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Controlled Clinical Trial

The 12-Month Effects of the Trauma Collaborative Care Intervention: A Nonrandomized Controlled Trial

Major Extremity Trauma Research Consortium (METRC). J Bone Joint Surg Am. .

Abstract

Background: Studies have suggested that patient-centered collaborative care in the early phases of recovery may assist providers and patients in managing the multifactorial consequences of injury and may lead to better outcomes. This cluster-controlled trial, conducted at 12 U.S. Level-I trauma centers, was designed to evaluate the impact of the Trauma Collaborative Care (TCC) program on 1-year outcomes following severe musculoskeletal injury.

Methods: Patients with high-energy orthopaedic trauma requiring surgical fixation were prospectively enrolled. Six sites implemented the TCC intervention as well as the Trauma Survivors Network (TSN), and the other 6 sites provided the standard of care. Participants were followed for 1 year, and a composite primary outcome measure composed of the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index, Patient Health Questionnaire-9 (PHQ-9), and Posttraumatic Stress Disorder Checklist (PCL) was assessed. A 2-stage, Bayesian hierarchical statistical procedure was used to characterize treatment effects. Sensitivity analyses were conducted to account for an error in the delivery of the intervention.

Results: There were 378 patients enrolled at 6 trauma centers implementing the TCC program, and 344 patients enrolled at 6 trauma centers providing usual care. Patient utilization of treatment components varied across the intervention sites: 29% of patients in the intervention group received all 5 key components (TSN handbook education, peer visits, recovery assessment, and calls before and after recovery assessment). Posterior estimates of the intention-to-treat effect suggested that the intervention did not have an appreciable effect: the odds of the composite outcome for the TCC group increased by 5% (95% credible interval, -40% to 63%). The estimates of the effect of receiving all 5 key intervention components were similar.

Conclusions: Despite prior work showing early positive effects, this analysis suggests that the TCC program as delivered did not have positive effects on patient outcomes at 1 year. It is not known whether programs that improve compliance or target specific subgroups would better meet the psychosocial needs of trauma survivors.

Level of evidence: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

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Conflict of interest statement

Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article ( http://links.lww.com/JBJS/H202 ).

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