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Enrolling by invitationNCT06330753TICPUpdated Nov 5, 2025

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

An interventional study of Trauma-informed Care Plan- in Trauma and Stressor Related Disorders, Violence, Structural and Violence, Domestic, sponsored by Brigham and Women's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-05.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • trauma
  • violence
  • abuse
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients less than 18 and older than 60.
  • patients too ill (medically/phytologically) to consent.
  • suicidal or homicidal patients.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

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

    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

  • OtherTrauma-informed Care Plan-

    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.

05

What researchers measure

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

    Time frame: 6-10 months

Secondary outcomes

  1. Intervention Appropriateness of Trauma-Informed Care plans

    This study is exploring the appropriateness of trauma-informed care plans by the percentage of patients and clinicians that find the TICP to be appropriate

    Time frame: 6-10 months

  2. Feasibility of the trauma-informed care plans

    This study is exploring the feasibility of the trauma-informed care plans by the percentage of patients and clinicians that find the trauma-informed care plans to be feasible.

    Time frame: 6- 10 months

06

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02116, United States
07

Registry details

Key details

Study ID
NCT06330753
Lead sponsor
Brigham and Women's Hospital
Responsible party
Annie Lewis-Oconnor, NP (Director of Research and Innovation, Center for Nursing Excellence, Brigham and Women's Hospital) — Principal investigator
First posted
Mar 26, 2024
Start date
Jan 17, 2025
Primary completion
May 15, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Nov 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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