HEART: The Healing and Empowerment Actions for Recovery from Trauma Trial

The HEART trial compares the current trauma recovery programming (TRP) versus a patient-centered approach that addresses comprehensive psychosocial needs (C-TRP).  Results from the HEART Trial will inform health decisions by determining the effectiveness of C-TRP and potential strengths, weaknesses, opportunities, and threats for implementation to help health systems, payors, and policymakers address patient-centered needs and allocate resources for physical trauma patients and their families.

Over 62 million people incur physical trauma each year in the United States (US). Currently, care focuses on visible injuries, but hidden scars – emotional, mental, and financial devastation – often go ignored and untreated. The ripple effect of trauma beyond the patient to the caregiver, healthcare providers, and community is underscored by society’s lack of systematic, financially-supported programs to address these wounds, leaving crucial gaps in patient-centered care. For patients recovering from complex orthopedic trauma (e.g., motor vehicle accidents, injurious falls, physical assault), the psychosocial burden of recovery can be especially difficult for patients and their care-partners.

The HEART Trial is a multicenter pragmatic, stepped-wedge cluster randomized, hybrid type I comparative effectiveness-implementation superiority trial. The HEART Trial will 1) compare the effectiveness of C-TRP to TRP on patient anxiety, mental health, acute healthcare utilization, pain, and substance use, 2) compare effectiveness of C-TRP relative to TRP on care-partner anxiety, mental health, acute healthcare utilization, pain and substance use, and 3) compare effectiveness of C-TRP relative to TRP on trauma healthcare worker burnout, confidence in trauma patient outcomes and impact of trauma recovery programming on healthcare personal well-being.

ClinicalTrials.gov Identifier: NCT07584252

See the participating clinical sites on the map below. For site details, visit ClinicalTrials.gov