Background & Aims
Acute orthopedic traumatic injuries are prevalent and costly. 20-50% of patients develop persistent pain and disability despite making good physical recovery, a significant public health burden. Psychosocial factors predict recovery after injury, yet to date there are no efficacious interventions for this population. We used a sequential approach to develop the Toolkit for Optimal Recovery after Injury (TOR), a program aimed at preventing persistent pain and disability after an acute orthopedic traumatic injury. We demonstrated TOR’s feasibility at one site10. We problem solved barriers to recruitment and surgeon referrals11 by conducting focus groups with 79 providers across 3 trauma centers, developing education materials and integrating our protocol within clinical care.
This is a multi-site RCT of TOR versus control. We aim to meet a priori set feasibility benchmarks and demonstrate that TOR leads to improvement in pain, physical/emotional function and other relevant outcome.
Methods
Surgeons provided warm hand-offs. Adults with an acute orthopedic traumatic injury 1-2 months earlier who endorses pain catastrophizing (PCS> 20) or pain anxiety (PASS-20> 40) were eligible, completed baseline and were randomized 1:1 to TOR or MEUC stratified by site. The Short Musculoskeletal Function Assessment Questionnaire (SMFA; physical function), Center for Epidemiologic Study of Depression (CES-D), The Posttraumatic Stress Disorder Checklist and putative mechanisms (PCS, PASS-20, mindfulness CAMS and coping MOCS ) were administered at baseline, post treatment and 3 months later. TOR is a 4-session live video–based, program. TOR teaches skills through didactics, in-session activities, and home practice. MEUC is an educational pamphlet. We calculated feasibility of recruitment and data collection, credibility, acceptability, satisfaction, adherence and fidelity. For efficacy analysis, we implemented a shared baseline linear mixed-model repeated-measures ANOVA.
Results
195 patients were eligible and randomized (97 to TOR, 98 to MEUC). We achieved or exceeded our predefined benchmarks for primary outcomes (89% feasibility of recruitment; 78% appropriateness; 79% survey completion rate; 99% TOR satisfaction; 73% acceptability of TOR, 100% fidelity). Data collection from staff was successful, and staff scored above the expected cutoff on question items related to satisfaction (75%), ease of referral (100%), patient cost-benefit (79%), clinic cost-benefit (72%), feasibility of implementation (79%), and appropriateness (88%). Referral rate was 89%. Participation in TOR, compared to MEUC, was associated with statistically significant improvement baseline to post-intervention in physical function (-7.34; P?.001), pain [at rest ( -1.17; P?.001), activity (-0.69; P?=?.026)], depression (-6.02; P?.001), and PCL (-3.80; P?=?.03)]. Improvements were clinically significant and sustained or continued through the 3 months follow-up, same as for mechanisms.
Conclusions
We met or exceeded all patient and staff feasibility benchmarks across the 4 sites. For patients, we observed excellent feasibility (ability to recruit participants quickly, randomize and retain them with low attrition rates). Most participants completed all study measures across the 3 timepoints, and those in TOR believed that the program would help improve their recovery trajectory and experienced high satisfaction with the program. For staff, we observed excellent feasibility of referrals, implementation, data collection, satisfaction, and ease of the study procedures and referral process. Taken together, these findings suggest that TOR content and methodology is appropriate for both patients and orthopedic trauma staff.
Efficacy results shows that TOR can improve physical function, pain, depression, and PTSD, and can prevent transition from acute to persistent pain. TOR has the potential to be the first efficacious program with smooth integration within orthopedic trauma clinics
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Presenting Author
Ana-Maria Vranceanu
Poster Authors
Ana-Maria Vranceanu
PhD
Massachusetts General Hospital/Harvard Medical School
Lead Author
Topics
- Treatment/Management: Pharmacology: Psychological and Rehabilitative Therapies