Comprehensive Trauma Recovery for Blunt Trauma

(HEART Trial)

Not yet recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stephanie Di Stasi
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to aid recovery from serious injuries requiring orthopedic surgery. It enhances standard recovery care with additional support, such as coaching and education, through comprehensive trauma recovery programming (C-TRP). The researchers aim to determine if this approach benefits not only patients but also their caregivers and healthcare workers. Individuals with moderate to severe bone or joint injuries who have been hospitalized for more than three days may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative recovery methods that could benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this psychosocial intervention is safe?

Research has shown that comprehensive trauma recovery programs (C-TRP) are generally manageable for participants. One study on this type of program found that it includes key components such as peer support, education, and resilience coaching. These elements aim to help patients feel safe and supported during their recovery.

Evidence from similar programs suggests that providing emotional and social support can enhance recovery without causing significant side effects. Reports have not indicated any serious negative outcomes or safety concerns with these support programs. This suggests that C-TRP is a safe option for those recovering from trauma, focusing on mental health and emotional well-being as part of the healing process.12345

Why are researchers excited about this trial?

Researchers are excited about Comprehensive Trauma Recovery Programming (C-TRP) because it offers a holistic approach to trauma recovery that goes beyond the standard care. Unlike typical protocols, which often leave patients to manage their recovery alone after discharge, C-TRP provides ongoing support with resiliency coaching and peer guidance. This innovative method includes education through multiple channels—online resources, print materials, and mobile apps—to suit different patient needs. Additionally, C-TRP addresses both physical and psychosocial aspects of recovery, potentially offering a more comprehensive and supportive healing process.

What evidence suggests that the Comprehensive trauma recovery programming (C-TRP) could be effective for trauma recovery?

Research has shown that programs like the Comprehensive Trauma Recovery Programming (C-TRP), a treatment arm in this trial, provide crucial emotional and social support to aid recovery from serious injuries. Participants in similar programs have reported better mental health, with fewer symptoms of depression and anxiety. C-TRP offers coaching to build resilience, peer support, and education to help patients manage their recovery. These components address the emotional and mental challenges that often accompany physical injuries. Although more research is needed to fully understand C-TRP's effectiveness in trauma centers, each part of the program is based on proven methods. Overall, these programs aim to improve recovery by focusing on the whole person, not just the physical injury.12367

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have had moderate to severe orthopedic injuries treated with surgery, are alert at enrollment, and expect to stay in the hospital over 72 hours. Participants must be able and willing to meet with a support coach during or soon after their hospital stay.

Inclusion Criteria

I am at least 18 years old.
Anticipated hospital length of stay greater than 72 hours
I have had surgery for moderate to severe bone or joint injuries.
See 9 more

Exclusion Criteria

No reliable internet access at baseline
Patients with significant burn injury
Care partners must be sufficiently fluent in English to consent and complete surveys without interpretive services
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Comprehensive Trauma Recovery Programming (C-TRP) intervention, including resiliency coaching, peer support, education, and navigation resources.

12-14 weeks
Ongoing support during hospitalization and post-discharge

Follow-up

Participants are monitored for anxiety and burnout using PROMIS-Anxiety and Maslach Burnout Inventory.

12 months
Assessments at 5-7 weeks, 12-14 weeks, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Comprehensive trauma recovery programming (C-TRP)

Trial Overview

The study compares a comprehensive trauma recovery program offering psychosocial support (C-TRP) against standard care chosen by doctors. It aims to see if extra emotional and practical help improves outcomes for patients, caregivers, and healthcare workers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Comprehensive trauma recovery programming (C-TRP)Experimental Treatment1 Intervention
Group II: Trauma recovery Programming (TRP)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stephanie Di Stasi

Lead Sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Citations

Implementation of a Stepped Care Program to Address ... - PMC

Although effectiveness of the full model in trauma centers has not yet been established, each step of the model is supported by a wide range ...

The Healing and Empowerment Actions for Recovery From ...

The study intervention (C-TRP) is a trauma-focused psychosocial intervention, with each site serving as its own control (TRP). Official Title.

Comprehensive Trauma Recovery for Blunt ...

The study compares a comprehensive trauma recovery program offering psychosocial support (C-TRP) against standard care chosen by doctors. It ...

Trauma Recovery

The Trauma Recovery Program (TRP) helps individuals manage the wide range of emotional, psychological, and physical symptoms that often follow trauma. This ...

Trauma Resilience and Recovery Program (TRRP)

TRRP maximizes its efficacy by employing both bedside and post-discharge screening. This dual-screening methodology captures a broader spectrum ...

Optimizing recovery after trauma: overview of existing ...

This review will highlight the importance of mental health and social support programming in optimizing outcomes after acute traumatic injury.

Recovery-oriented and trauma-informed care for people with ...

Recovery-oriented and trauma-informed models of care can contribute to the implementation of non-coercive practices, which show promising ...