Trial Outcomes & Findings for Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults (NCT NCT04118595)

Last Updated: 2023-11-21

Results Overview

The Brief Pain Inventory-Short Form (BPI-SF) is an 11-item measure of pain severity and pain interference. Patients will rate their pain severity and interference over the past week on a 0-10 numeric scale at 3 discrete time periods (1, 3, and 6 months). End points for the severity items include 0 which equals "no pain" and 10 which equals "pain as bad as you can imagine." End points for the interference items include 0 which equals "does not interfere" and 10 "completely interferes." Higher scores reflect more pain severity and more pain interference. A composite score will be calculated by averaging scores from both the pain severity and interference items (all 11-items). Results from the 3 time periods will be analyzed longitudinally.

Recruitment status

COMPLETED

Study phase

Target enrollment

330 participants

Primary outcome timeframe

Month 1 (following ED or orthopedic urgent care visit) to Month 6

Results posted on

2023-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Full Intervention (Video + Telecare + PCP Communication) Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A video link is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the emergency department (ED) or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care Patients will receive the typical care provided by medical personnel for their acute pain.
Overall Study STARTED	112	107	111
Overall Study Completed Week 1 Within 7-day Window	107	97	108
Overall Study Completed Month 1 Within 7-day Window	108	100	106
Overall Study Completed Month 3 Within 7-day Window	103	99	102
Overall Study Completed Month 6 Within 7-day Window	104	96	102
Overall Study Completed Month 12 Within 7-day Window	101	88	96
Overall Study COMPLETED	101	88	96
Overall Study NOT COMPLETED	11	19	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Intervention (Video + Telecare + PCP Communication) n=112 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=107 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=111 Participants Patients will receive the typical care provided by medical personnel for their acute pain.	Total n=330 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 9.9 • n=5 Participants	65.1 years STANDARD_DEVIATION 8.8 • n=7 Participants	64.4 years STANDARD_DEVIATION 8.7 • n=5 Participants	64.7 years STANDARD_DEVIATION 9.1 • n=4 Participants
Age, Customized < 65 years old	60 Participants n=5 Participants	58 Participants n=7 Participants	59 Participants n=5 Participants	177 Participants n=4 Participants
Age, Customized 65 years old or greater	52 Participants n=5 Participants	49 Participants n=7 Participants	52 Participants n=5 Participants	153 Participants n=4 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	72 Participants n=7 Participants	72 Participants n=5 Participants	226 Participants n=4 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	35 Participants n=7 Participants	39 Participants n=5 Participants	104 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants	104 Participants n=7 Participants	107 Participants n=5 Participants	319 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	17 Participants n=7 Participants	18 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	74 Participants n=7 Participants	82 Participants n=5 Participants	239 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	32 Participants n=4 Participants
Region of Enrollment United States	112 Participants n=5 Participants	107 Participants n=7 Participants	111 Participants n=5 Participants	330 Participants n=4 Participants

PRIMARY outcome

Timeframe: Month 1 (following ED or orthopedic urgent care visit) to Month 6

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
Mean Brief Pain Inventory-Short Form (BPI-SF) Combined Pain Severity and Interference Score Month 1	2.67 score on a scale Standard Deviation 2.09	2.99 score on a scale Standard Deviation 2.12	2.94 score on a scale Standard Deviation 2.29
Mean Brief Pain Inventory-Short Form (BPI-SF) Combined Pain Severity and Interference Score Month 3	1.90 score on a scale Standard Deviation 1.80	2.18 score on a scale Standard Deviation 2.15	2.57 score on a scale Standard Deviation 2.34
Mean Brief Pain Inventory-Short Form (BPI-SF) Combined Pain Severity and Interference Score Month 6	2.22 score on a scale Standard Deviation 2.21	2.35 score on a scale Standard Deviation 2.46	2.84 score on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: Up to 6 months

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

The BPI-SF is an 11-item measure of pain severity and pain interference with severity entailing 4 of the questions. Patient's will rate their pain severity over the past week on a 0-10 numeric rating scale, with a higher score reflecting more pain. End points include 0 which equals "no pain" and 10 which equals "pain as bad as you can imagine." Answers to each of the 4 questions will be reported as mean values for each time point (Month 1, 3, and 6).

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
Mean Pain Severity on the Brief Pain Inventory-Short Form (BPI-SF) Score Month 1	2.69 score on a scale Standard Deviation 2.00	2.94 score on a scale Standard Deviation 1.97	2.90 score on a scale Standard Deviation 2.14
Mean Pain Severity on the Brief Pain Inventory-Short Form (BPI-SF) Score Month 3	1.98 score on a scale Standard Deviation 1.79	2.22 score on a scale Standard Deviation 2.10	2.53 score on a scale Standard Deviation 2.25
Mean Pain Severity on the Brief Pain Inventory-Short Form (BPI-SF) Score Month 6	2.30 score on a scale Standard Deviation 2.14	2.45 score on a scale Standard Deviation 2.42	2.81 score on a scale Standard Deviation 2.27

SECONDARY outcome

Timeframe: Up to 6 months

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

The BPI-SF is an 11-item measure of pain severity and pain interference with interference with daily activities entailing 7 of the questions. Patient's will rate their pain interference over the past week, on a 0-10 scale with a higher score reflecting more interference with activities. End points include 0 which equals "does not interfere" and 10 which equals "completely interferes." Answers to each of the 7 questions will be reported as mean values for each time point (Month 1, 3, and 6).

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
Mean Pain Interference on the BPI-SF Score Month 1	2.64 score on a scale Standard Deviation 2.40	3.04 score on a scale Standard Deviation 2.51	2.98 score on a scale Standard Deviation 2.70
Mean Pain Interference on the BPI-SF Score Month 3	1.82 score on a scale Standard Deviation 1.99	2.14 score on a scale Standard Deviation 2.38	2.61 score on a scale Standard Deviation 2.64
Mean Pain Interference on the BPI-SF Score Month 6	2.14 score on a scale Standard Deviation 2.43	2.26 score on a scale Standard Deviation 2.72	2.88 score on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: 1 week & 1 month

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

The Opioid-Related Symptom Distress Scale (OR-SDS) will be used to assess subject-reported levels of frequency and severity of 10 symptoms known to be associated with opioid medication usage, such as drowsiness, dizziness, and constipation. Added to this measure are 5 other symptoms (including shortness of breath, falls, abdominal pain, bloody stool, and 'other'), reflecting side effects for patients taking NSAIDs or acetaminophen. Symptom frequency will be rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly, with higher ratings indicating more frequent symptoms (ranging from 1 to 4). Symptom severity will be rated as: 1=slightly, 2-moderate, 3=severe, or 4=very severe, with higher ratings indicating more severe symptoms (ranging from 1 to 4). Patients who deny a symptom will be given a score of zero for frequency and severity. A mean symptom distress score was calculated for each arm based on patient reported scores for severity and frequency.

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=108 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
Mean Symptom Distress Score Week 1	0.062 score on a scale Standard Deviation 0.138	0.063 score on a scale Standard Deviation 0.164	0.043 score on a scale Standard Deviation 0.103
Mean Symptom Distress Score Month 1	0.023 score on a scale Standard Deviation 0.080	0.019 score on a scale Standard Deviation 0.065	0.015 score on a scale Standard Deviation 0.058

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

Patients will be asked if they have used opioids during the past week at each of the follow-up time points. This will be a dichotomous outcome in which 'yes' will indicate opioid use in the past week and 'no' will indicate no opioid use in the past week.

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
Percent of Participants With Opioid Use During the Past Week Month 6-Yes	2.9 percentage of participants	3.1 percentage of participants	5.9 percentage of participants
Percent of Participants With Opioid Use During the Past Week Month 1-Yes	5.6 percentage of participants	9.0 percentage of participants	5.7 percentage of participants
Percent of Participants With Opioid Use During the Past Week Month 3-Yes	1.9 percentage of participants	1.0 percentage of participants	4.9 percentage of participants
Percent of Participants With Opioid Use During the Past Week Month 12-Yes	3.0 percentage of participants	3.4 percentage of participants	6.3 percentage of participants

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow. One participant in the Full Intervention (Video + Telecare + PCP communication) arm did not complete the 3 month assessment.

Patient report of physical function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function-4 for chores, ability to use stairs, walking, and running errands on a 5-point scale with end points of "without any difficulty" and "unable to do." Higher scores reflect less difficulty. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Therefore a person with a T-score of 40 is one SD below the mean. These values will be compared to the value obtained from the baseline assessment with patients reporting their function prior to injury. The data will be analyzed longitudinally for months 1, 3, 6, and 12 (following the approach for BPI for the primary outcome).

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
PROMIS Measure: Mean T-score Physical Function-4 Month 1	42.19 T-score Standard Deviation 8.10	40.83 T-score Standard Deviation 8.26	41.17 T-score Standard Deviation 8.54
PROMIS Measure: Mean T-score Physical Function-4 Month 3	45.25 T-score Standard Deviation 8.23	44.21 T-score Standard Deviation 8.51	43.49 T-score Standard Deviation 9.26
PROMIS Measure: Mean T-score Physical Function-4 Month 6	45.88 T-score Standard Deviation 9.00	44.41 T-score Standard Deviation 8.98	43.51 T-score Standard Deviation 9.23
PROMIS Measure: Mean T-score Physical Function-4 Month 12	47.44 T-score Standard Deviation 8.54	46.29 T-score Standard Deviation 8.94	44.50 T-score Standard Deviation 9.54

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

Patient reported global health will be measured using the PROMIS Global Health-Physical 2a. General physical health is measured on a 5-point scale with end points of "excellent" and "poor," where higher scores reflect better physical health. Ability to carry out every day physical activities is measured on a 5 point scale with end points of "completely" and "not at all," where higher scores reflect better ability. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Therefore a person with a T-score of 40 is one SD below the mean. These values will be compared to the value obtained from the baseline assessment with patients reporting their global health prior to injury. The data will be analyzed longitudinally for months 1, 3, 6, and 12 (following the approach for BPI for the primary outcome).

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
PROMIS Measure: Mean T-score Global Health-Physical 2a Month 1	47.73 T-score Standard Deviation 7.89	45.72 T-score Standard Deviation 7.54	46.75 T-score Standard Deviation 8.24
PROMIS Measure: Mean T-score Global Health-Physical 2a Month 3	49.67 T-score Standard Deviation 7.14	48.55 T-score Standard Deviation 8.14	47.47 T-score Standard Deviation 9.42
PROMIS Measure: Mean T-score Global Health-Physical 2a Month 6	49.68 T-score Standard Deviation 8.91	47.87 T-score Standard Deviation 8.69	47.52 T-score Standard Deviation 8.89
PROMIS Measure: Mean T-score Global Health-Physical 2a Month 12	50.08 T-score Standard Deviation 7.92	49.16 T-score Standard Deviation 8.69	47.78 T-score Standard Deviation 8.58

SECONDARY outcome

Timeframe: Up to 12 months

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

The number of days the patient spent in the hospital after ED discharge will be collected through patient report and the patient's electronic health record. Analysis will compare these outcomes among study arms.

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
Healthcare Utilization, Mean Days in the Hospital Month 1	0.04 Days Standard Deviation 0.30	0.00 Days Standard Deviation 0.00	0.05 Days Standard Deviation 0.29
Healthcare Utilization, Mean Days in the Hospital Month 3	0.16 Days Standard Deviation 1.22	0.01 Days Standard Deviation 0.10	0.10 Days Standard Deviation 0.67
Healthcare Utilization, Mean Days in the Hospital Month 6	0.00 Days Standard Deviation 0.00	0.07 Days Standard Deviation 0.62	0.17 Days Standard Deviation 1.23
Healthcare Utilization, Mean Days in the Hospital Month 12	0.23 Days Standard Deviation 1.09	0.09 Days Standard Deviation 0.39	0.13 Days Standard Deviation 0.39

SECONDARY outcome

Timeframe: Up to 12 months

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

The number of visits to an ED or urgent care will be collected through patient report and the patient's electronic health record. Analysis will compare these outcomes among study arms.

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
Healthcare Utilization, Mean Number of Visits to ED/Urgent Care Month 1	0.09 visits Standard Deviation 0.35	0.06 visits Standard Deviation 0.24	0.04 visits Standard Deviation 0.19
Healthcare Utilization, Mean Number of Visits to ED/Urgent Care Month 3	0.25 visits Standard Deviation 0.85	0.08 visits Standard Deviation 0.31	0.25 visits Standard Deviation 0.62
Healthcare Utilization, Mean Number of Visits to ED/Urgent Care Month 6	0.30 visits Standard Deviation 1.45	0.26 visits Standard Deviation 0.71	0.40 visits Standard Deviation 1.08
Healthcare Utilization, Mean Number of Visits to ED/Urgent Care Month 12	0.40 visits Standard Deviation 1.21	0.35 visits Standard Deviation 0.76	0.35 visits Standard Deviation 0.74

SECONDARY outcome

Timeframe: Up to 12 months

Population: Data are reported for all participants who completed each Follow-up within the 7-day window. There was participant attrition over time as shown in the Participant Flow.

The number of visits to a primary care provider's office will be collected through patient report and the patient's electronic health record. Analysis will compare these outcomes among study arms.

Outcome measures

Outcome measures
Measure	Full Intervention (Video + Telecare + PCP Communication) n=108 Participants Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=100 Participants Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=106 Participants Patients will receive the typical care provided by medical personnel for their acute pain.
Healthcare Utilization, Mean Number of Visits to Primary Care Provider Month 1	0.15 visits Standard Deviation 0.43	0.22 visits Standard Deviation 0.48	0.17 visits Standard Deviation 0.42
Healthcare Utilization, Mean Number of Visits to Primary Care Provider Month 3	0.50 visits Standard Deviation 0.78	0.42 visits Standard Deviation 0.86	0.53 visits Standard Deviation 0.77
Healthcare Utilization, Mean Number of Visits to Primary Care Provider Month 6	0.70 visits Standard Deviation 0.82	0.79 visits Standard Deviation 1.05	0.81 visits Standard Deviation 0.96
Healthcare Utilization, Mean Number of Visits to Primary Care Provider Month 12	1.50 visits Standard Deviation 1.73	1.10 visits Standard Deviation 1.12	1.39 visits Standard Deviation 1.35

Adverse Events

Full Intervention (Video + Telecare + PCP Communication)

Serious events: 6 serious events

Other events: 38 other events

Deaths: 0 deaths

Video-only Intervention

Serious events: 3 serious events

Other events: 39 other events

Deaths: 1 deaths

Usual Care

Serious events: 13 serious events

Other events: 35 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Full Intervention (Video + Telecare + PCP Communication) n=112 participants at risk Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=107 participants at risk Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=111 participants at risk Patients will receive the typical care provided by medical personnel for their acute pain.
Gastrointestinal disorders Abdominal pain	3.6% 4/112 • Number of events 7 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	6.5% 7/107 • Number of events 9 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	6.3% 7/111 • Number of events 7 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Gastrointestinal disorders Constipation	4.5% 5/112 • Number of events 9 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	6.5% 7/107 • Number of events 7 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	9.9% 11/111 • Number of events 13 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
General disorders Fatigue	10.7% 12/112 • Number of events 14 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	9.3% 10/107 • Number of events 11 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	7.2% 8/111 • Number of events 9 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Musculoskeletal and connective tissue disorders Back pain	3.6% 4/112 • Number of events 5 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	1.9% 2/107 • Number of events 2 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	7.2% 8/111 • Number of events 9 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Musculoskeletal and connective tissue disorders Pain in extremity	10.7% 12/112 • Number of events 15 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	9.3% 10/107 • Number of events 10 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	5.4% 6/111 • Number of events 8 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Nervous system disorders Concentration impairment	6.2% 7/112 • Number of events 8 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	2.8% 3/107 • Number of events 3 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	2.7% 3/111 • Number of events 3 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Nervous system disorders Dizziness	5.4% 6/112 • Number of events 6 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	1.9% 2/107 • Number of events 2 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	2.7% 3/111 • Number of events 3 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Nervous system disorders Somnolence	15.2% 17/112 • Number of events 20 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	15.0% 16/107 • Number of events 17 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	12.6% 14/111 • Number of events 17 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.

Additional Information

Michelle Meyer, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-6539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Full Intervention (Video + Telecare + PCP Communication) n=112 participants at risk Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient. Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Correspondence with Primary Care Provider: Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up.	Video-only Intervention n=107 participants at risk Patients in this arm will watch an interactive pain management video. Educational Video: The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.	Usual Care n=111 participants at risk Patients will receive the typical care provided by medical personnel for their acute pain.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	1.8% 2/111 • Number of events 2 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Cardiac disorders Atrial flutter	0.89% 1/112 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/111 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Cardiac disorders Cardiac arrest	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Gastrointestinal disorders Abdominal pain	1.8% 2/112 • Number of events 2 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
General disorders Non-cardiac chest pain	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Hepatobiliary disorders Cholecystitis	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	1.8% 2/111 • Number of events 2 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Infections and infestations Bacteremia	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Infections and infestations Bladder infection	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.93% 1/107 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/111 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Infections and infestations Endocarditis infective	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.93% 1/107 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/111 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Infections and infestations Enterocolitis infectious	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Infections and infestations Urinary tract infection	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Injury, poisoning and procedural complications Fall	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	1.8% 2/111 • Number of events 2 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Injury, poisoning and procedural complications Hip fracture	0.89% 1/112 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/111 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Nervous system disorders Stroke	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.93% 1/107 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/111 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Nervous system disorders Syncope	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Psychiatric disorders Anxiety	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Psychiatric disorders Suicidal ideation	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.89% 1/112 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/111 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.00% 0/112 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.
Vascular disorders Thromboembolic event	0.89% 1/112 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.00% 0/107 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.	0.90% 1/111 • Number of events 1 • Adverse events (AEs) were collected from time of consent to study exit, up to 12 months.