Trial Outcomes & Findings for Toolkit for Optimal Recovery After Orthopedic Injury (NCT NCT04973696)

NCT ID: NCT04973696

Last Updated: 2025-06-27

Results Overview

We will report number of participants who consented to participate out of those eligible, evaluated at the end of study. This number is not the same as the number who were actually enrolled and randomized in the trial (195).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 195 participants
• Primary outcome timeframe: At the end of the entire enrollment period of the study, which was about 1 year and 10 months.
• Results posted on: 2025-06-27

Participant Flow

The two arms for this study and participant flow are listed below. As stated in the Protocol Section, several secondary outcomes will assess whether the intervention (TOR) tested in this study is feasible, acceptable, and satisfactory, from the point of view of the clinic staff and surgeons in the orthopedic clinics that are the sites of recruitment for study participants. Since they were not actually enrolled in the study, these clinic staff and surgeons are not included in participant flow.

Participant milestones

Measure	Toolkit for Optimal Recovery After Orthopedic Injury (TOR) - Active Toolkit for Optimal Recovery after Orthopedic Injury: The Toolkit (TOR) is a 4-session, individual, live video, synchronous program developed specifically for patients with orthopedic acute injuries who are at risk for chronic pain and disability. The program teaches evidence-based mind-body skills (e.g., relaxation and mindfulness; myths about pain; activity pacing; acceptance and values based goal setting). Patients randomized to this arm gain access to a website downloaded on their phones as an app. The website includes explainer videos of skills and recordings of mindfulness and relaxation exercises. In addition, participants will receive usual care as determined by their medical team.	Minimally Enhanced Usual Care (MEUC) - Control In the Minimally Enhanced Usual Care (MEUC) arm of the study, patients who are randomized to this arm will receive educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, these participants will receive usual care as determined by their medical team.
Overall Study STARTED	97	98
Overall Study COMPLETED	74	81
Overall Study NOT COMPLETED	23	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Toolkit for Optimal Recovery After Orthopedic Injury

Baseline characteristics by cohort

Measure	Toolkit for Optimal Recovery After Orthopedic Injury - Active n=97 Participants Toolkit for Optimal Recovery after Orthopedic Injury: The Toolkit (TOR) is a 4-session, individual, live video, synchronous program developed specifically for patients with orthopedic acute injuries who are at risk for chronic pain and disability. The program teaches evidence-based mind-body skills (e.g., relaxation and mindfulness; myths about pain; activity pacing; acceptance and values based goal setting). Patients randomized to this arm gain access to a website downloaded on their phones as an app. The website includes explainer videos of skills and recordings of mindfulness and relaxation exercises. In addition, participants will receive usual care as determined by their medical team.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants In the Minimally Enhanced Usual Care (MEUC) arm of the study, patients who are randomized to this arm will receive educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, these participants will receive usual care as determined by their medical team.	Total n=195 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 17 • n=5 Participants	45 years STANDARD_DEVIATION 16 • n=7 Participants	44 years STANDARD_DEVIATION 17 • n=5 Participants
Sex/Gender, Customized Man	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Sex/Gender, Customized Woman	63 Participants n=5 Participants	62 Participants n=7 Participants	125 Participants n=5 Participants
Sex/Gender, Customized Genderqueer/gender fluid/nonbinary	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex/Gender, Customized Prefer not to say	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	66 Participants n=7 Participants	131 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants	83 Participants n=7 Participants	163 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Education Less than high school	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Education Completed high school or GED	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Education Some college/Associates degree	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Education Completed 4 years of college	30 Participants n=5 Participants	19 Participants n=7 Participants	49 Participants n=5 Participants
Education Graduate/professional degree	15 Participants n=5 Participants	23 Participants n=7 Participants	38 Participants n=5 Participants
Education Choose Not to Answer	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Employment Employed full-time	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Employment Employed part-time	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Employment Going to school full or part-time	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Employment Keeping House/Housemaker	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Employment Other	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Employment Retired	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Employment Unemployed	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Employment Choose Not to Answer	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Income Less than $10,000	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Income $10,000 to less than $15,000	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Income $15,000 to less than $20,000	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Income $20,000 to less than $25,000	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Income $25,000 to less than $35,000	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Income $35,000 to less than $50,000	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Income $50,000 to less than $75,000	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Income $75,000 or more	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Income Choose Not to Answer	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Marital Status Single, never married	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Marital Status Married	35 Participants n=5 Participants	39 Participants n=7 Participants	74 Participants n=5 Participants
Marital Status Living with significant other	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Marital Status Separated/Divorced	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Marital Status Widowed	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Marital Status Choose Not to Answer	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of the entire enrollment period of the study, which was about 1 year and 10 months.

We will report number of participants who consented to participate out of those eligible, evaluated at the end of study. This number is not the same as the number who were actually enrolled and randomized in the trial (195).

Outcome measures

Measure	All Participants (TOR and MEUC) n=235 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Recruitment Among All Patients	210 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline

A measure of participant's expectations and believed credibility for program (i.e. appropriateness), as assessed by the Credibility and Expectancy Scale. This scale has a range of 3 to 27 points, with higher ratings indicating more belief that the program is logical and will help with the intended outcome. This measure was the count of patients who scored above or below the scale's theoretical midpoint (i.e. the midpoint is not based on the collected data) on the Credibility and Expectancy Scale

Outcome measures

Measure	All Participants (TOR and MEUC) n=90 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Appropriateness of Treatment Program, Rated by Participants Randomized to TOR and Assessed by the Credibility and Expectancy Scale	66 Participants	—	—	—

PRIMARY outcome

Timeframe: On the participant level, data was collected over the course of 4 months (baseline through followup). Counts reported here and described above were summed at the final end of all study activities (a total duration of 1 year 10 months).

Population: Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together, since regardless of study arm, all participants completed the same baseline, posttest, and followup questionnaires at the timepoints. This is appropriate for the feasibility benchmark of data collection; we are only assessing the feasibility of collecting these questionnaires for this outcome across the study as a whole, and not comparing the feasibility between the arms.

This outcome will assess the feasibility of collecting the data used to assess and compare the TOR intervention to MEUC (usual care); it is not looking at the data itself or comparing two arms, but just the feasibility of collecting it. To assess this feasibility marker of our intervention, we will report the number of patients who complete their study assessments, for both TOR and MEUC together, at all of their required timepoints in the study.

Outcome measures

Measure	All Participants (TOR and MEUC) n=195 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Data Collection	154 Participants	—	—	—

PRIMARY outcome

Timeframe: Assessed at Post-Test, which was approximately 4 weeks after a participant's enrollment in the study and baseline assessment.

Population: The number of participants analyzed in this outcome reflects the number of participants (out of the total enrolled and randomized) who made it to the posttest assessment and could complete this questionnaire (i.e. did not drop out and were not lost to followup in the time since randomization and enrollment).

Participant's satisfaction with treatment received after completion of TOR was assessed using the Client Satisfaction Questionnaire. In this questionnaire, items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. This measure is the count of participants in TOR who scored above the scale's theoretical midpoint (i.e. the midpoint is not based on the collected data) on the Client Satisfaction Questionnaire.

Outcome measures

Measure	All Participants (TOR and MEUC) n=76 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Acceptability of Treatment (Satisfaction) Assessed With the Client Satisfaction Questionnaire (Patients Randomized to TOR Only)	75 Participants	—	—	—

PRIMARY outcome

Timeframe: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts of attendance were summed at the end of the study (~1 year and 10 months).

We will the report total number of patients in the TOR intervention who attend all four sessions that are part of their intervention.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Acceptability of TOR (Attendance for Patients Randomized to TOR)	71 Participants	—	—	—

SECONDARY outcome

Timeframe: Assessed the counts for the study as a whole at the end of study completion, which was about 1 year and 10 months. On the participant level, the time from randomization to posttest took place over an average of 4 weeks.

We will report number of participants who are randomized within one arm and complete post-test.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients	76 Participants	93 Participants	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected over the course of the entire intervention/study (about 1 year and 7 months total from the start of referrals and participant enrollment in the study).

Population: The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to referrals, from surgeons and staff, to the study overall, and it is not related to the actual treatment arms themselves. This is appropriate for the feasibility benchmark assessing whether referrals for this trial (and thus our intervention) are feasible for surgeons and clinic staff to complete.

We will report the number of surgeons and staff who make at least 5 referrals across all four sites, to assess whether referrals for this trial (and thus our intervention) are feasible for surgeons and clinic staff to complete. Referrals could come from providers at any point over the course of the intervention/study.

Outcome measures

Measure	All Participants (TOR and MEUC) n=28 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Orthopedic Staff Feasibility of Referral	25 Participants	—	—	—

SECONDARY outcome

Timeframe: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).

Population: Total number of participants enrolled per site listed here. Deviations reported for each site are for TOR and MEUC together, since regardless of study arm, deviations were reported and logged for all arms together at each site. This is appropriate for the fidelity benchmark of collecting minor deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.

We will report number of minor deviations per each separate, site among all enrolled patients (both TOR and MEUC combined at each site). This is appropriate for the fidelity benchmark of collecting minor deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.

Outcome measures

Measure	All Participants (TOR and MEUC) n=66 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=48 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center n=30 Participants Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine n=51 Participants Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Fidelity to Study Procedures (Minor Deviations)	7 minor protocol deviations	1 minor protocol deviations	4 minor protocol deviations	3 minor protocol deviations

SECONDARY outcome

Timeframe: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).

Population: Total number of participants enrolled per site listed here. Deviations reported for each site are for TOR and MEUC together, since regardless of study arm, deviations were reported and logged for all arms together at each site. This is appropriate for the fidelity benchmark of collecting major deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.

We will report number of major deviations per each separate site among all enrolled patients (both TOR and MEUC combined at each site). This is appropriate for the fidelity benchmark of collecting major deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.

Outcome measures

Measure	All Participants (TOR and MEUC) n=66 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=48 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center n=30 Participants Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine n=51 Participants Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Fidelity to Study Procedures (Major Deviations)	1 major protocol deviations	0 major protocol deviations	0 major protocol deviations	0 major protocol deviations

SECONDARY outcome

Timeframe: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts were then summed at the end of the study (~1 year and 10 months).

The number of participants who returned at least 1 out of 3 homework logs (1 log was given per week), that have 4 out of 7 days of practice reported on those logs.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Adherence to TOR Homework	74 Participants	—	—	—

SECONDARY outcome

Timeframe: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts that met our criteria noted in the description were then summed at the end of the study (~1 year and 10 months).

Population: This measure refers to the total number of sessions that were analyzed for this outcome. The overall number of units analyzed that is reported here reflects the total number of sessions delivered over the course of the study, that were then scored by therapists. The overall number of participants analyzed is the number of participants who were randomized to the TOR arm of the study, and received the intervention (which included the sessions (units) that were analyzed for this outcome).

Assessed using a therapist scale rating patient participation quality in each session. We will report the number of TOR sessions that scored over 7 (out of 10 possible points). There were 304 total TOR sessions delivered over the course of the study, and 294 sessions received a score over 7.

Outcome measures

Measure	All Participants (TOR and MEUC) n=304 Sessions Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Acceptability as Rated by Therapist	294 count of sessions	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who were involved with referring patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the satisfaction of surgeons and staff, in regards to the intervention and the study procedures as a whole, and it is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who score over 7 on the satisfaction question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=20 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Perceived Satisfaction of Staff	15 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who were involved with referring patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the perceived acceptability of surgeons and staff, in regards to the intervention and the study procedures as a whole (referral process), and it is not related to the actual treatment arms themselves.

We will report number of surgeons and staff who score over 7 on the ease of referral question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=22 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Perceived Acceptability of Staff Regarding Ease of Referral	22 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the perceived acceptability of surgeons and staff, in regards to the intervention and cost-benefit to the patient, and it is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who score over 7 on the cost-benefit (patient) question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=19 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Perceived Acceptability of Staff Regarding Cost-benefit for the Patient	15 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the acceptability of surgeons and staff, in regards to the intervention and the study procedures (cost-benefit to the clinic) as a whole, and it is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who score over 7 on the cost-benefit (clinic) question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=21 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Perceived Acceptability of Staff Regarding Cost-benefit for the Clinic	15 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of implementing the study, as perceived by surgeons and staff, in regards to the intervention and the study procedures as a whole; it is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who score over 7 on the feasibility of study implementation question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=19 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Study Implementation as Perceived by Study Staff	15 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the perceived appropriateness (relevance, compatibility) of the study for their patient population, in regards to the intervention and the study procedures as a whole; it is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who score over 7 on the appropriateness question that was part of a study feedback survey. This question assessed the the perceived appropriateness (relevance, compatibility) of the study for their patient population.

Outcome measures

Measure	All Participants (TOR and MEUC) n=16 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Appropriateness as Perceived by Study Staff	14 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff satisfaction, in regards to the intervention and the study procedures as a whole; it is not related to the actual treatment arms themselves.

We will report the number of surgeons and study staff who complete the study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=22 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Obtaining Data on Orthopedic Staff Satisfaction	20 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff ease of referrals, in regards to the intervention and the study procedures as a whole; it is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who complete the ease of referral question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=22 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Obtaining Data on Orthopedic Staff Perceived Ease of Referrals	22 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff perceived cost-benefit measure for the patient. This is in regards to the intervention and the study procedures as a whole, and is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who complete the perceived cost-benefit (patient) measure question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=22 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Patient) Measure	19 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff perceived cost-benefit measure for the clinic. This is in regards to the intervention and the study procedures as a whole, and is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who complete the perceived cost-benefit (clinic) measure question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=22 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Clinic) Measure	21 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff feasibility of study implementation in their clinic. This is in regards to the intervention and the study procedures as a whole, and is not related to the actual treatment arms themselves

We will report the number of surgeons and staff who complete the feasibility question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=22 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Obtaining Data on Orthopedic Staff Feasibility of Study Implementation	19 Participants	—	—	—

SECONDARY outcome

Timeframe: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff perceived appropriateness. This is in regards to the intervention and the study procedures as a whole, and is not related to the actual treatment arms themselves.

We will report the number of surgeons and staff who complete the perceived appropriateness measure question that was part of a study feedback survey.

Outcome measures

Measure	All Participants (TOR and MEUC) n=22 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Obtaining Data on Orthopedic Staff Perceived Appropriateness	16 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

Rating of participant's pain at rest using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. Means reported reflect the Mean Difference between the timepoints noted in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Numerical Rating Scale (Pain at Rest), Change Between Time Points Baseline to Post-Treatment	-1.7 score on a scale Interval -2.1 to -1.2	-0.5 score on a scale Interval -0.9 to -0.1	—	—
Numerical Rating Scale (Pain at Rest), Change Between Time Points Baseline to Follow-Up	-2.0 score on a scale Interval -2.5 to -1.5	-1.0 score on a scale Interval -1.5 to -0.5	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

Rate of participant's pain with activity using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. Means reported reflect the Mean Difference between the timepoints noted in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Numerical Rating Scale (Pain During Activity), Change Between Time Points Baseline to Post-Treatment	-1.7 score on a scale Interval -2.1 to -1.2	-1.0 score on a scale Interval -1.4 to -0.6	—	—
Numerical Rating Scale (Pain During Activity), Change Between Time Points Baseline to Follow-Up	-2.4 score on a scale Interval -3.0 to -1.8	-1.6 score on a scale Interval -2.1 to -1.0	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

The Short Musculoskeletal Function Assessment (SMFA) assesses one's self-report physical function and the extent to which a participant is bothered by their functioning. Scores range from 46 to 230. Higher scores represent greater dysfunction or bother. Means reported reflect the Mean Difference between the time points noted in the row title. A decrease in score between baseline and posttest or baseline and followup (i.e. a more negative difference, or larger negative difference, as reported here) reflects improvements in physical function.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Short Musculoskeletal Function Assessment (SMFA), Change Between Time Points Posttest minus baseline mean score	-16 score on a scale Interval -19.0 to -13.0	-8 score on a scale Interval -11.0 to -6.0	—	—
Short Musculoskeletal Function Assessment (SMFA), Change Between Time Points Followup minus baseline mean score	-24 score on a scale Interval -27.0 to -20.0	-18 score on a scale Interval -21.0 to -14.0	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

The Center for Epidemiologic Study of Depression (CES-D), a 20-item measure assesses depressive symptomatology; scores range from 0-60 and higher scores indicate greater depressive symptomatology. Means reported reflect the Mean Difference between the timepoints noted in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Center for Epidemiologic Study of Depression (CES-D), Change Between Time Points Baseline to post-test	-9 score on a scale Interval -11.0 to -7.0	-3 score on a scale Interval -5.0 to -1.0	—	—
Center for Epidemiologic Study of Depression (CES-D), Change Between Time Points Baseline to follow-up	-10 score on a scale Interval -12.0 to -7.0	-4 score on a scale Interval -7.0 to -2.0	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

The 17-item PTSD Checklist civilian measure assesses post-traumatic stress; scores range from 17-85 with higher scores indicating greater post-traumatic stress. Means reported reflect the Mean Difference between the timepoints noted in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
PTSD Checklist- Civilian Measure (PCL-C), Change Between Time Points Baseline to post-test	-7 score on a scale Interval -10.0 to -5.0	-4 score on a scale Interval -6.0 to -1.0	—	—
PTSD Checklist- Civilian Measure (PCL-C), Change Between Time Points Baseline to follow-up	-10 score on a scale Interval -13.0 to -7.0	-5 score on a scale Interval -8.0 to -2.0	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

The Pain Catastrophizing Scale (PCS), a 13-item measure assesses hopelessness, helplessness and rumination about pain, with items ranging from 0-4 and total scores ranging from 0-52, with higher scores indicating higher levels of pain catastrophizing. Means reported reflect the Mean Difference between the timepoints noted in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Pain Catastrophizing Scale (PCS), Change Between Time Points. Baseline to post-test	-14 score on a scale Interval -16.0 to -12.0	-6 score on a scale Interval -8.0 to -4.0	—	—
Pain Catastrophizing Scale (PCS), Change Between Time Points. Baseline to follow-up	-15 score on a scale Interval -18.0 to -12.0	-8 score on a scale Interval -10.0 to -5.0	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

The Pain Anxiety Scale, short form (PASS-20) assesses cognitive and somatic symptoms of anxiety, items range from 0-100 and higher scores indicating greater pain anxiety. Means reported reflect the Mean Difference between the timepoints noted in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Pain Anxiety Scale, Short Form (PASS-20), Change Between Time Points Baseline to follow-up	-38 score on a scale Interval -42.0 to -33.0	-19 score on a scale Interval -23.0 to -14.0	—	—
Pain Anxiety Scale, Short Form (PASS-20), Change Between Time Points Baseline to post-test	-38 score on a scale Interval -41.0 to -34.0	-13 score on a scale Interval -17.0 to -10.0	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

The Measure of Current Status (MOCS-A) assesses ability to engage in healthy coping skills, with items ranging from 0-4, total score ranging from 0-52, and higher scores reflect greater self-perceived current state. Means reported reflect the Mean Difference between the timepoints noted in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Measure of Current Status (MOCS-A), Change Between Time Points. Baseline to post-test	0.4 score on a scale Interval 0.2 to 0.5	0.01 score on a scale Interval -0.1 to 0.2	—	—
Measure of Current Status (MOCS-A), Change Between Time Points. Baseline to follow-up	0.4 score on a scale Interval 0.3 to 0.6	0.1 score on a scale Interval -0.03 to 0.3	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

The Measure of Current Status (MOCS-A) assesses mindfulness, with total score ranging from 12-48. Higher scores indicate greater mindfulness. Means reported reflect the Mean Difference between the timepoints noted in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Cognitive and Affective Mindfulness Scale- Revised (CAMS-R), Change Between Time Points. Baseline to post-test	3 score on a scale Interval 2.0 to 4.0	0 score on a scale Interval -1.0 to 1.0	—	—
Cognitive and Affective Mindfulness Scale- Revised (CAMS-R), Change Between Time Points. Baseline to follow-up	3 score on a scale Interval 1.0 to 4.0	1 score on a scale Interval -1.0 to 2.0	—	—

SECONDARY outcome

Timeframe: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).

Population: The data reported are for TOR and MEUC together, since regardless of study arm, any use of non-narcotic rescue analgesics were reported and logged for all arms together. This is appropriate for the feasibility benchmark of collecting non-narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.

We will report number of participants with complete data on non-narcotic rescue analgesics (non-narcotic) among all enrolled patients with orthopedic injuries, via self-report log. This is appropriate for the feasibility benchmark of collecting non-narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.

Outcome measures

Measure	All Participants (TOR and MEUC) n=195 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Data Collection of Rescue Analgesics (Non-narcotic)	155 Participants	—	—	—

SECONDARY outcome

Timeframe: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).

Population: The data reported are for TOR and MEUC together, since regardless of study arm, any use of narcotic rescue analgesics were reported and logged for all arms together. This is appropriate for the feasibility benchmark of collecting narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.

We will report number of participants with complete data on narcotic rescue analgesics among all enrolled patients with orthopedic injuries, via self-report log. This is appropriate for the feasibility benchmark of collecting narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.

Outcome measures

Measure	All Participants (TOR and MEUC) n=195 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Data Collection of Rescue Analgesics (Narcotic)	155 Participants	—	—	—

SECONDARY outcome

Timeframe: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).

Population: Total number of participants enrolled per site are listed here. The adverse events reported below for each site are for TOR and MEUC together, since regardless of study arm, adverse events were reported and logged for all arms together at each site. This is appropriate because we are not comparing adverse events in any way between the arms.

We will report number of adverse events (serious and non-serious) per each separate site among all enrolled patients with orthopedic injuries (both TOR and MEUC combined at each site). This is appropriate to report the arms together because we are not comparing adverse events in any way between the arms.

Definition of an adverse event in this study: throughout the study, subjects were monitored for the occurrence of events defined as any undesirable experience or unanticipated risk. Lack of effect of treatment was not considered an event.

Outcome measures

Measure	All Participants (TOR and MEUC) n=66 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=48 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center n=30 Participants Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine n=51 Participants Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Adverse Events (Serious and Non-serious) Adverse Events	0 adverse events	2 adverse events	0 adverse events	1 adverse events
Adverse Events (Serious and Non-serious) Serious Adverse Events	1 adverse events	0 adverse events	1 adverse events	1 adverse events

SECONDARY outcome

Timeframe: On the participant level, data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).

Population: The total number of participants randomized in the TOR arm is listed here. The completed data on adverse events reported below is only for TOR. This is appropriate for the feasibility benchmark of collecting the adverse event data, since we are interested in whether it is feasible for our treatment, which is part of the TOR arm only.

We will report number of participants with completed data on their adverse events, among enrolled patients with orthopedic injuries in the TOR arm. Data will be reported by study clinicians, for all sites and both arms combined. This is appropriate for the feasibility benchmark of collecting the adverse event data, since we are interested in whether it is feasible for our treatment/study intervention, which is part of the TOR arm only.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Feasibility of Data Collection of Adverse Events	97 participants with completed data	—	—	—

SECONDARY outcome

Timeframe: On the fidelity reviewer level, the data for this outcome was collected over the course of the intervention as the sessions were delivered by therapists (4 weeks of delivery). Reviews/points were then summed at end of the study (~1 year and 10 months).

Population: 16 clinicians/therapists were randomly selected to review fidelity checks. Since study clinicians were only used in the intervention arm (TOR), study arm, i.e. TOR vs. MEUC, is not an applicable breakdown for this outcome, as those in the MEUC arm would not have received the intervention, i.e. the sessions that were assessed in this fidelity check.

We will report the number of adherence/fidelity "points" that therapists achieved from reviewers during their fidelity checks, over the course of the study. These fidelity checks were done by assessing a checklist review of audio recordings of the sessions, and were completed by 2 raters, for 16 different TOR therapists.

Outcome measures

Measure	All Participants (TOR and MEUC) n=7360 Points Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Therapist Adherence/Fidelity to Session	6829 Points	—	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

Population: The overall number of participants analyzed reflects all participants who were analyzed at the first timepoint/row below (i.e. baseline). The actual numbers analyzed, reported at each timepoint/row below, reflects that some were lost to follow-up or had dropped out of the study by the different time points.

Self-report of past-week rescue analgesics use was collected from participants at each assessment timepoint and is reported here for each timepoint; timepoint is indicated in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=83 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Within-group Use of Rescue Analgesics (Non-narcotic) Post-test non-narcotic use (percentage)	9.2 percentage	60.6 percentage	—	—
Within-group Use of Rescue Analgesics (Non-narcotic) Baseline non-narcotic use (percentage)	22.9 percentage	64.3 percentage	—	—
Within-group Use of Rescue Analgesics (Non-narcotic) Follow-up non-narcotic use (percentage)	9.5 percentage	61.3 percentage	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

Population: The overall number of participants analyzed reflects all participants who were analyzed at the first timepoint/row below (i.e. baseline). The actual numbers analyzed, reported at each timepoint/row below, reflects that some were lost to follow-up or had dropped out of the study by the different time points.

Self-report of past-week rescue analgesics use was collected from participants at each assessment timepoint and is reported here for each timepoint; timepoint is indicated in the row title.

Outcome measures

Measure	All Participants (TOR and MEUC) n=83 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Within Group Use of Rescue Analgesics (Narcotic) Baseline narcotic use (percentage)	22.9 percentage	33.7 percentage	—	—
Within Group Use of Rescue Analgesics (Narcotic) Post-test narcotic use (percentage)	9.2 percentage	19.1 percentage	—	—
Within Group Use of Rescue Analgesics (Narcotic) Follow-up narcotic use (percentage)	9.5 percentage	13.8 percentage	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0), Post-Test (Week 4)

We assessed the correlation between change scores in the Short Musculoskeletal Function Assessment (SMFA) and change scores on the following mechanistic targets of the TOR intervention: Center for Epidemiologic Study of Depression (CES-D), Posttraumatic Stress Disorder Checklist (PCL), Pain Catastrophizing Scale (PCS), Pain Anxiety Scale Short Form (PASS), Measures of Current Status (MOCS), and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Change scores reflected the difference in score between baseline (week 0) and post-test (week 4). Possible correlations range from 0-1; the closer a correlation score is to 1, the more correlated (associated, related) the two measures being compared are. This means that the closer a correlation in change scores is to 1, the more related a change in SMFA is to a change in the named mechanistic target of the intervention.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
2-tailed Pearson Correlation (TOR and MEUC) SMFA Change-CES-D Change-Correlation	0.6 2-tailed Pearson Correlation (r) Interval 0.428 to 0.724	0.7 2-tailed Pearson Correlation (r) Interval 0.539 to 0.769	—	—
2-tailed Pearson Correlation (TOR and MEUC) SMFA Change-PCL Change Correlation	0.4 2-tailed Pearson Correlation (r) Interval 0.244 to 0.609	0.5 2-tailed Pearson Correlation (r) Interval 0.364 to 0.662	—	—
2-tailed Pearson Correlation (TOR and MEUC) SMFA Change-PCS Change Correlation	0.3 2-tailed Pearson Correlation (r) Interval 0.044 to 0.465	0.4 2-tailed Pearson Correlation (r) Interval 0.208 to 0.553	—	—
2-tailed Pearson Correlation (TOR and MEUC) SMFA Change-PASS Change Correlation	0.3 2-tailed Pearson Correlation (r) Interval 0.072 to 0.486	0.5 2-tailed Pearson Correlation (r) Interval 0.313 to 0.626	—	—
2-tailed Pearson Correlation (TOR and MEUC) SMFA Change-MOCS Change Correlation	-0.2 2-tailed Pearson Correlation (r) Interval -0.407 to 0.027	-0.3 2-tailed Pearson Correlation (r) Interval -0.473 to -0.098	—	—
2-tailed Pearson Correlation (TOR and MEUC) SMFA Change-CAMS-R Change Correlation	-0.2 2-tailed Pearson Correlation (r) Interval -0.389 to 0.049	-0.3 2-tailed Pearson Correlation (r) Interval -0.489 to -0.118	—	—

SECONDARY outcome

Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)

The PROMIS Physical Function (v1.0 8b) assesses one's ability to carry out activities that require physical actions, ranging from self-care to social activities to work. Raw scores are converted to T scores, which are standardized scores based on the average in the population (a score of 50 would indicate matching the average score in the reference, general population. T scores range from 8-40, with a higher score reflecting greater physical function and ability to carry out the activity. Means reported reflect the Mean Difference between the time points in the row titles listed. For the differences reported, a bigger difference thus reflects a greater improvement in physical function.

Outcome measures

Measure	All Participants (TOR and MEUC) n=97 Participants Includes all individuals who were eligible to participate (adult with recent, acute orthopedic trauma) across all four sites.	Minimally Enhanced Usual Care (MEUC) - Control n=98 Participants The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Minimally Enhanced Usual Care (MEUC): The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.	Vanderbilt University Medical Center Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Physical Function Self-report, Change Between Time Points Baseline to Post-Treatment	6 T score Interval 5.0 to 8.0	4 T score Interval 3.0 to 6.0	—	—
Physical Function Self-report, Change Between Time Points Baseline to Follow-Up	12 T score Interval 10.0 to 14.0	11 T score Interval 9.0 to 12.0	—	—

Adverse Events

Massachusetts General Hospital

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Dell Medical School

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Vanderbilt University Medical Center

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

University of Kentucky College of Medicine

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Massachusetts General Hospital n=66 participants at risk Team at the Center for Health Outcomes and Interdisciplinary Research at Massachusetts General Hospital	Dell Medical School n=48 participants at risk Department of Surgery and Perioperative Care, Dell Medical School	Vanderbilt University Medical Center n=30 participants at risk Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine n=51 participants at risk Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Psychiatric disorders Suicide attempt and subsequent hospitalization	1.5% 1/66 • Number of events 1 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/48 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/30 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/51 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.
Infections and infestations Diagnosis of ankle septic arthritis and hospitalization	0.00% 0/66 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/48 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/30 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	2.0% 1/51 • Number of events 1 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.
Infections and infestations Pneumonia and hospitalization	0.00% 0/66 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/48 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	3.3% 1/30 • Number of events 1 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/51 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.

Other adverse events

Measure	Massachusetts General Hospital n=66 participants at risk Team at the Center for Health Outcomes and Interdisciplinary Research at Massachusetts General Hospital	Dell Medical School n=48 participants at risk Department of Surgery and Perioperative Care, Dell Medical School	Vanderbilt University Medical Center n=30 participants at risk Department of Physical Medicine \& Rehabilitation, Osher Center for Integrative Health, Vanderbilt University Medical Center	University of Kentucky College of Medicine n=51 participants at risk Department of Orthopaedic Surgery \& Sports Medicine, University of Kentucky College of Medicine
Musculoskeletal and connective tissue disorders Increased pain severity with movement	0.00% 0/66 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/48 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/30 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	2.0% 1/51 • Number of events 1 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.
Musculoskeletal and connective tissue disorders Fall onto ankle	0.00% 0/66 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	2.1% 1/48 • Number of events 1 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/30 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/51 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.
Musculoskeletal and connective tissue disorders New onset of jaw pain	0.00% 0/66 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	2.1% 1/48 • Number of events 1 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/30 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.	0.00% 0/51 • Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period). Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together (although broken down by site), since adverse events were collected as a whole for both TOR and MEUC together.

Additional Information

Dr. Ana-Maria Vranceanu

Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital

Phone: 617-724-4977

Email: avranceanu@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place