Trauma-Informed Care Plan for Trauma and Stressor Related Disorders

(TICP Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Under 18, Over 60, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called a Trauma-Informed Care Plan to improve care for people with complex health needs. It aims to determine if these care plans enhance healthcare experiences by reducing stress and helping patients feel more understood by their healthcare providers. The trial will also assess whether healthcare teams find the plans useful and easy to implement. Individuals who frequently visit the doctor and have complicated health conditions might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions that could enhance patient care experiences.

Do I need to stop my current medications to join the trial?

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 trauma-informed care plans are safe and effective?

Research has shown that trauma-informed care plans focus on understanding and addressing how trauma affects patients. This approach prioritizes safety and aims to prevent re-traumatization during care. Studies have found that these care plans help create a supportive environment for patients with trauma histories.

Although specific data on negative effects related to trauma-informed care plans is lacking, they are generally well-received due to their emphasis on understanding and empathy. The goal is to improve patient comfort and satisfaction without introducing new risks. Since this approach does not involve invasive procedures, it is considered safe for use in various healthcare settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Trauma-informed Care Plan (TICP) because it integrates a personalized approach directly into a patient's electronic medical record, offering a tailored treatment strategy for trauma and stressor-related disorders. Unlike traditional methods that might focus solely on therapy or medication, TICP emphasizes understanding and addressing the unique trauma experiences of each patient in a structured way. This approach aims to improve how acceptable, appropriate, and feasible care is for both patients and clinicians, potentially leading to more effective and compassionate treatment outcomes.

What evidence suggests that the Trauma-Informed Care Plan is effective for trauma and stressor-related disorders?

Research has shown that trauma-informed care plans can improve patient health. These plans foster strong relationships between patients and healthcare providers, reducing stress and anxiety during visits. The trial will evaluate the feasibility and acceptability of trauma-informed care plans (TICP) by asking both patient and clinician participants to rate their experiences. This approach focuses on understanding a patient's life experiences, which can lead to better mental health and substance use outcomes. Patients and staff find this method acceptable in various healthcare settings. Overall, trauma-informed care plans can increase patient satisfaction and make patients feel more understood and cared for by their healthcare team. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking adults aged 18-60 with complex health care needs and frequent appointments. Participants must consent to the study. It's designed for those affected by trauma such as sexual violence, domestic abuse, or nerve injuries.

Inclusion Criteria

I often go to the doctor or hospital for my health.

I have multiple health issues that require ongoing medical care.

I agree to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation and evaluation of Trauma-Informed Care Plans (TICP) in electronic health records

6-10 months

Follow-up

Participants are monitored for feedback on the acceptability, feasibility, and appropriateness of TICP

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trauma-informed Care Plan

Trial Overview The study tests a Trauma-Informed Care Plan (TICP) integrated into electronic health records. It aims to see if TICPs are acceptable, appropriate, and feasible for clinicians and if they improve patient satisfaction and reduce stress during care.

How Is the Trial Designed?

Group I: Feasibility and Acceptability of Trauma-informed Care Plans (TICP) Experimental Treatment 1 Intervention

Per our IRB protocol - Patient participants and clinician participants will be asked (via a survey) to rate their: Acceptability of the Trauma-informed Care Plan, the Appropriateness of the TICP and the feasibility of the TICP. The intervention is the TICP place in the Electronic Medical Record right below the patient's name (on the Storyboard).

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10940237/

Effectiveness of Trauma-Informed Care Implementation in ... This study aimed to understand the mechanisms and outcomes effective in implementing TIC across health systems using a systematic review of reviews and realist ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949875924002832

Feasibility and outcomes of a trauma-informed model ... The novel TIC model was acceptable for residential clients and staff and was associated with improved mental and substance use outcomes.

3. samhsa.gov samhsa.gov/sites/default/files/programs_campaigns/childrens_mental_health/atc-whitepaper-040616.pdf

Key Ingredients for Successful Trauma-Informed Care ... Trauma-informed care acknowledges the need to understand a patient's life experiences in order to deliver effective care and has the potential to improve ...

4. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/related_files/trauma-informed-care.pdf

Trauma Informed Care: A Systematic Review The reports and assessments provide organizations with comprehensive, evidence-based information on common medical conditions and new healthcare ...

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11813-3

Evaluation of a trauma-informed care (TIC) training program ... Research has shown that TIC is effective in improving patient health outcomes, establishing good patient-provider relationships, and ...

6. mlnha.org mlnha.org/wp-content/uploads/2023/02/Trauma-Informed-Care-for-MANHA-Feb-2023-Final.pdf

TRAUMA INFORMED CARE WHAT. IS TRAUMA-INFORMED CARE. • Trauma informed care is an approach that aims to engage people with histories of trauma, recognize the presence of trauma ...

7. nursinghomehelp.org nursinghomehelp.org/wp-content/uploads/2019/10/TRAUMA-INFORMED-CARE.pdf

Trauma-informed Care Trauma: an intense event that threatens safety or security of an individual. • Toxic Stress: recurring negative experiences that threaten safety ...