Welcome to the first issue of the HEART Trial newsletter. Every three months, we will share public updates and explain parts of the research work. We will also introduce the people helping guide the work and share ways to get involved when opportunities are available. Because this is our first newsletter, we want to introduce the trial and provide an update on where the work stands.
What is the HEART Trial?
HEART stands for Healing and Empowerment Actions for Recovery from Trauma. Led by Carmen Quatman, MD, PhD, at The Ohio State University, HEART is a five-year, multicenter study funded by the Patient-Centered Outcomes Research Institute (PCORI). This trial is studying how best to support adults recovering from major orthopaedic injuries that require surgery. It compares current trauma recovery programming with a more comprehensive program that adds resiliency coaching, peer support, education, and help navigating resources. The added support begins during hospitalization and continues during recovery, with patients and care partners choosing which resources meet their needs.
We will follow participants for 12 months and will examine anxiety and other mental health outcomes, along with pain, substance use, and the use of emergency and hospital care. The study will also examine how the two approaches affect care partners and healthcare workers.
The trial is led by Ohio State in collaboration with Johns Hopkins University, Vanderbilt University, the University of Maryland, the University of Colorado, Dartmouth Hitchcock Medical Center, University of California-Irvine, and Hennepin County Medical Center.
Where we are now: moving from startup to enrollment
Since the project began in January 2026, teams at the participating sites have focused on the work required to launch the trial. This has included receiving the required ethics approvals, finalizing study contracts, planning how the study will be carried out at each site, and training study personnel.
Those preparations have now brought the trial right up to the point of enrollment as we expect to begin enrolling participants any day. Enrollment marks an important transition from planning the trial to carrying it out with participants. The team will continue to review early processes and address implementation questions as enrollment progresses.
Engagement spotlight: the Stakeholder Engagement Team
PCORI is an innovative funder that requires considerable stakeholder participation to ensure that studies completed reflect patient and stakeholder preferences as much as possible. As such, the HEART Trial has formed a Stakeholder Engagement Team (SET) whose members add perspectives that complement those of the study’s scientific and operational teams. The SET includes people who have experienced serious trauma and care partners; clinicians and professional coaches; and representatives from health systems, advocacy organizations, health policy, and payer organizations.
During startup, SET members advised the research team on how potential participants should be approached about the study. Their feedback emphasized respectful, voluntary, and neutral enrollment conversations. They also advised on assessing a person’s readiness to hear about the study, training research coordinators, timing follow-up from resiliency coaches, and helping participants remain involved over time. This input has helped the team refine its recruitment and retention plans.
The SET’s role will continue throughout the trial. Members will provide regular feedback on implementation and participant experience as enrollment proceeds. Later, they will help the research team interpret the findings and plan how results should be shared with patients, care partners, clinicians, and the public. We are grateful to the members of the SET for contributing their time and experience to the HEART Trial!
Next steps
Future newsletters will report enrollment milestones and explain how different parts of the trial work. We will also introduce members of the broader HEART team and share opportunities to learn more or participate when they become available.
To learn more, visit the HEART Trial overview or view the study record on ClinicalTrials.gov.
Funding acknowledgment
Research reported in this newsletter was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (BPS-2024C3-41889). The statements in this newsletter are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI).