Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan

NCT06330753 | Enrolling By Invitation

• 1 other identifier: 2024P000682
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. Patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. The aims to are: Aim 1: Explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of Trauma-Informed Care Plans(TICP) when used by clinicians on the health care team (HCTC). Hypothesis 1: HCTC using the TICP will report its acceptability, feasibility, satisfaction and ease of use. Hypothesis 2: HCTC will report heightened awareness of intersection of trauma and social determinants of health. Hypothesis 3: HCTC will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient. Aim 2: Explore the impact of having a TICP by patients understanding how the TICP may have improved their experience around care and treatment. Hypothesis 1: patients will report: improved satisfaction with their care. Hypothesis 2: patients will report feeling better known by HCT. Hypothesis 3: will report less stress and anxiety related to health care encounters.

Conditions

Trauma and Stressor Related Disorders; Violence, Structural; Violence, Domestic; Violence, Sexual

Keywords

trauma; violence; abuse

Outcome Measures

Primary Outcomes (1)

• Acceptability of Trauma Informed Care Plans

  This study is exploring the acceptability of trauma-informed care plans by the percentage of patients and clinicians that find the TICP acceptable

  6-10 months

Secondary Outcomes (2)

• Intervention Appropriateness of Trauma-Informed Care plans

  6-10 months

• Feasibility of the trauma-informed care plans

  6- 10 months

Study Arms (1)

Feasibility and Acceptability of Trauma-informed Care Plans (TICP)

OTHER

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).

Other: Trauma-informed Care Plan-

Interventions

Trauma-informed Care Plan- OTHER

Per our IRB protocol patient participates will be consented for this study. A member of the healthcare team ( licensed nurse, social worker or doctor) will conduct the TICP with the patient. The TICP will be placed in the electronic medical record right below the patients name. The workflow is such is that if any plan of care placed on the Storyboard (under the patient's name) should be read first before engaging with a patient.

Feasibility and Acceptability of Trauma-informed Care Plans (TICP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients ( ages 18-60)
• who have frequent health care appointments
• have complex health care needs
• consent to participate in study
• English or spanish speaking.

You may not qualify if:

• patients less than 18 and older than 60.
• patients too ill (medically/phytologically) to consent.
• suicidal or homicidal patients.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

Trauma and Stressor Related Disorders; Coitus; Wounds and Injuries

Condition Hierarchy (Ancestors)

Mental Disorders; Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants (patients and providers) will be de-identified
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Innovation, Center for Nursing Excellence

Model Details: This is a prospective study designed to explore the acceptability, intervention appropriateness of trauma-informed care plans and the feasibility of trauma-informed care plans by patients and members of the health care team

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 26, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)