Trial Outcomes & Findings for Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse (NCT NCT04154384)

Results Overview

For participants in the single-arm pilot study and in the dual-arm, clinical-trial portion of the study, daily pain within the last 24 hours was assessed using a 10-point Likert scale where 1 = no pain and 10 = severe pain. After Week 2, pain was assessed only during the follow-up visits.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

333 participants

Primary outcome timeframe

Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Results posted on

2024-11-21

Participant Flow

Participants were recruited from Grady Memorial Hospital in Atlanta, Georgia, USA.

The nature of this preliminary research began as a single-arm pilot study but due to the COVID-19 pandemic, the pilot was suspended. Instead, a two-arm Clinical Trial was commenced due to time constraints at a time when non-essential personnel, including research staff, were permitted to safely return to the fast-paced clinical environment once infection control measures were established. The outcomes of the clinical trial portion did not apply to the pilot group.

Participant milestones

Participant milestones
Measure	Life Care Specialist (LCS) Intervention In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Standard of Care With Clinical Coordination Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one-year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Overall Study STARTED	104	108	121
Overall Study COMPLETED	72	57	121
Overall Study NOT COMPLETED	32	51	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Life Care Specialist (LCS) Intervention In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Standard of Care With Clinical Coordination Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.
Overall Study Lost to Follow-up	24	33
Overall Study Withdrawal by Subject	7	18
Overall Study Missing outcome data	1	0

Baseline Characteristics

Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Pilot Study of Pain Management Strategies n=121 Participants Orthopedic trauma patients will work with a LifeCare Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one-year post-operation. An official pain management protocol will be developed during the pilot portion of this study.	Total n=250 Participants Total of all reporting groups
Age, Continuous	43.15 years STANDARD_DEVIATION 18.17 • n=5 Participants	42.46 years STANDARD_DEVIATION 16.97 • n=7 Participants	38.82 years STANDARD_DEVIATION 15.00 • n=5 Participants	42.84 years STANDARD_DEVIATION 17.59 • n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	33 Participants n=7 Participants	52 Participants n=5 Participants	124 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	24 Participants n=7 Participants	69 Participants n=5 Participants	126 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	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 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	53 Participants n=5 Participants	41 Participants n=7 Participants	94 Participants n=5 Participants	188 Participants n=4 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	44 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	72 participants n=5 Participants	57 participants n=7 Participants	121 participants n=5 Participants	129 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Population: Outcomes for the pilot study participants were only collected up to Week 2.

For participants in the single-arm pilot study and in the dual-arm, clinical-trial portion of the study, daily pain within the last 24 hours was assessed using a 10-point Likert scale where 1 = no pain and 10 = severe pain. After Week 2, pain was assessed only during the follow-up visits.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies n=121 Participants Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Numeric Rating Scale Average Pain Score Day 1 (during inpatient hospitalization)	7.94 units on a scale Standard Deviation 2.42	7.62 units on a scale Standard Deviation 2.72	8.43 units on a scale Standard Deviation 2.80
Numeric Rating Scale Average Pain Score Week 2	5.64 units on a scale Standard Deviation 2.93	5.88 units on a scale Standard Deviation 2.76	4.74 units on a scale Standard Deviation 2.68
Numeric Rating Scale Average Pain Score Week 6	4.14 units on a scale Standard Deviation 3.27	4.36 units on a scale Standard Deviation 2.91	—
Numeric Rating Scale Average Pain Score Month 3	3.72 units on a scale Standard Deviation 3.16	3.79 units on a scale Standard Deviation 3.09	—

PRIMARY outcome

Timeframe: Month 3

Population: This outcome applies to the clinical trial groups.

The number of participants in the dual-arm, clinical-trial portion of the study reporting a decrease in the NRS average pain score at 3 months follow-up compared to the baseline visit.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Number of Participants With Improvement in the Numeric Rating Scale (NRS) Average Pain Score	42 Participants	64 Participants	—

PRIMARY outcome

Timeframe: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Population: This outcome applies to the clinical trial groups.

For participants in the dual-arm, clinical trial portion of the study, severity of insomnia, sleep disruption, and sleep quality over the past seven days is assessed with the 4-item PROMIS Sleep Disturbance - Short Form. Responses are given on a 5-point Likert scale where 1 is equivalent to best possible and 5 is equivalent to worst possible. Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and standard deviation of 10. Scores below 50 indicate better sleep than the average person.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score Day 1 (during inpatient hospitalization)	51.57 T-score Standard Deviation 10.21	52.89 T-score Standard Deviation 10.70	—
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score Week 2	58.85 T-score Standard Deviation 9.56	60.16 T-score Standard Deviation 8.69	—
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score Week 6	53.81 T-score Standard Deviation 11.56	54.74 T-score Standard Deviation 11.26	—
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score Month 3	51.28 T-score Standard Deviation 13.13	52.68 T-score Standard Deviation 11.92	—

PRIMARY outcome

Timeframe: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Population: This outcome applies to the clinical trial groups only.

For participants in the dual-arm, clinical trial portion of the study, self-reported pain interference with activities is assessed with the PROMIS Pain Interference - Short Form. Responses to the 4 items are given on a 5-point Likert scale from 1 (no interference) to 5 (much interference). Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and standard deviation of 10. Scores above 50 indicate worse pain interference than the average person.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
PROMIS Pain Interference - Short Form Score Day 1 (during inpatient hospitalization)	56.24 T-score Standard Deviation 11.52	54.14 T-score Standard Deviation 12.17	—
PROMIS Pain Interference - Short Form Score Week 2	65.99 T-score Standard Deviation 7.16	65.19 T-score Standard Deviation 6.37	—
PROMIS Pain Interference - Short Form Score Week 6	59.36 T-score Standard Deviation 7.93	62.28 T-score Standard Deviation 8.59	—
PROMIS Pain Interference - Short Form Score Month 3	58.19 T-score Standard Deviation 9.27	58.89 T-score Standard Deviation 10.54	—

PRIMARY outcome

Timeframe: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Population: This outcome applies to the clinical trial groups only.

For participants in the dual-arm, clinical trial portion of the study, self-reported capability to conduct physical activity is assessed with the PROMIS Physical Function - Short Form. Responses to the 4 items are given on a 5-point Likert scale where 1 = unable to do and 5 = without any difficulty. Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better physical function than the average person.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
PROMIS Physical Function - Short Form Score Week 6	33.59 T-score Standard Deviation 8.43	30.33 T-score Standard Deviation 7.31	—
PROMIS Physical Function - Short Form Score Day 1 (during inpatient hospitalization)	42.31 T-score Standard Deviation 13.14	42.85 T-score Standard Deviation 13.75	—
PROMIS Physical Function - Short Form Score Week 2	26.82 T-score Standard Deviation 6.55	26.56 T-score Standard Deviation 5.27	—
PROMIS Physical Function - Short Form Score Month 3	37.53 T-score Standard Deviation 8.00	37.22 T-score Standard Deviation 8.43	—

SECONDARY outcome

Timeframe: Day 1 (during inpatient hospitalization)

For participants in the single-arm pilot study, and in the dual-arm, clinical-trial portion of the study, opioid utilization during inpatient hospitalization was recorded in daily morphine milligram equivalents.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies n=121 Participants Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Opioid Utilization	30.00 milligrams Interval 22.5 to 30.0	22.52 milligrams Interval 22.5 to 30.0	39.77 milligrams Interval 25.0 to 49.82

SECONDARY outcome

Timeframe: Day 1 (during inpatient hospitalization), Month 3

Population: This outcome applies to the clinical trial groups only.

For participants in the dual-arm, clinical trial portion of the study, accuracy of knowledge about opioids (3 questions) and opioid-related risks (5 questions) is assessed with an Opioid Literacy Tool (OLT). Accuracy of opioid knowledge responses are given on a dichotomous scale (yes/no). Responses for accuracy of knowledge about opioid-related risks are given on a 7-point scale where 1 = definitely true and 7 = definitely false. The score is reported as the percent of correct responses.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Opioid Literacy Tool (OLT) Score Day 1 (during inpatient hospitalization)	32.69 percentage out of 100% Standard Deviation 31.37	32.02 percentage out of 100% Standard Deviation 27.50	—
Opioid Literacy Tool (OLT) Score Month 3	31.25 percentage out of 100% Standard Deviation 33.32	33.20 percentage out of 100% Standard Deviation 34.63	—

SECONDARY outcome

Timeframe: Up to 72 hours (during inpatient hospitalization)

Population: This outcome applies to the clinical trial groups only. Only participants who wore the sleeping tracking device were included in this outcome.

For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices captured continuous postoperative functional outcomes among patients during their hospitalization and up to 72 hours postoperatively. Total sleep time is assessed in minutes of sleep per night.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=56 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=63 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Total Sleep Time	236.95 minutes/night Standard Deviation 55.6	267.34 minutes/night Standard Deviation 99.71	—

SECONDARY outcome

Timeframe: Day 1 (during inpatient hospitalization)

Population: This outcome applies to the clinical trial groups only. Only participants who wore the sleeping tracking device were included in this outcome.

For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices captured continuous postoperative functional outcomes among patients during their hospitalization. The percentage of sleep fragmentation is assessed as the number of awakenings and sleep stage shifts divided by the total sleep time \*100.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=56 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=63 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Percentage of Sleep Fragmentation	32.68 percentage of sleep fragmentation Standard Deviation 15.17	33.77 percentage of sleep fragmentation Standard Deviation 15.29	—

SECONDARY outcome

Timeframe: Week 2

Population: This outcome applies to the clinical trial groups only.

For participants in the dual-arm, clinical-trial portion of the study, patient satisfaction with clinical care was assessed with a modified Press Ganey Integrated Survey. This survey captured a comprehensive picture of each participant's care experience. Participants were asked "Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay?" Higher scores indicate higher satisfaction.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Patient Satisfaction Survey	7.23 units on a scale Standard Deviation 2.36	7.77 units on a scale Standard Deviation 2.39	—

SECONDARY outcome

Timeframe: Week 2

Population: This analysis includes participants in the pilot group who attended their 2 weeks post-operative follow-up appointment.

For participants in the single-arm pilot study, patient satisfaction with clinical care was assessed by asking: "Did you find the interactions with the Life Care Specialist, (LCS) helpful in managing your pain?" Response choices ranged from "strongly agree" to "strongly disagree". Responses were dichotomized as finding the LCS helpful or not finding the LCS helpful with managing pain.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=80 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Number of Pilot Study Participants Reporting Satisfaction With Clinical Care	—	79 Participants	—

SECONDARY outcome

Timeframe: Week 2

Population: This outcome applies to the clinical trial groups only.

For participants in the dual-arm, clinical-trial portion of the study, the PAC-SYM instrument was used to assess the severity of patient-reported symptoms of constipation. The instrument includes 12 items with subscales assessing abdominal, rectal, and stool symptoms. Responses are given on a 5-point scale ranging from 0 (symptom absent) to 4 (very severe symptoms). The total score is calculated as the mean of all response and ranges from 0 to 4, where lower scores indicate lower symptom burden.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Patient Assessment of Constipation-Symptoms (PAC-SYM) Score	0.79 score on a scale Standard Deviation 0.76	0.49 score on a scale Standard Deviation 0.74	—

SECONDARY outcome

Timeframe: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Population: This outcome applies to the clinical trial groups only.

The Defense and Veterans Pain Rating Scale is a patient-reported outcome used to measure the degree to which pain influenced a respondent's ability to function over the prior 24 hours. Scores range from 0 to 10 with higher scores indicating impaired functioning due to pain.

Outcome measures

Outcome measures
Measure	Standard of Care With Clinical Coordination n=57 Participants Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options. Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.	Life Care Specialist (LCS) Intervention n=72 Participants In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks). Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.	Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post-operation. An official pain management protocol will be developed during the pilot portion of this study.
Defense and Veterans Pain Rating Scale Score Day 1 (during inpatient hospitalization)	7.49 score on a scale Standard Deviation 2.67	6.84 score on a scale Standard Deviation 3.04	—
Defense and Veterans Pain Rating Scale Score Week 2	5.54 score on a scale Standard Deviation 2.69	5.35 score on a scale Standard Deviation 2.82	—
Defense and Veterans Pain Rating Scale Score Week 6	4.02 score on a scale Standard Deviation 3.09	4.13 score on a scale Standard Deviation 2.76	—
Defense and Veterans Pain Rating Scale Score Month 3	3.56 score on a scale Standard Deviation 3.25	3.68 score on a scale Standard Deviation 2.95	—

Adverse Events

Life Care Specialist (LCS) Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care With Clinical Coordination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pilot Study of Pain Management Strategies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mara L. Schenker

Emory University

Phone: 404-778-1550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place