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

NCT ID: NCT06330753

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-17

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants (patients and providers) will be de-identified

Study Groups

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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).

Group Type OTHER

Trauma-informed Care Plan-

Intervention Type 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.

Interventions

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Trauma-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.

Intervention Type OTHER

Eligibility Criteria

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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

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Annie Lewis-Oconnor, NP

Director of Research and Innovation, Center for Nursing Excellence

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2024P000682

Identifier Type: -

Identifier Source: org_study_id

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