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NCT06330753 Clinical Trial

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

Violence, Domestic Clinical Trial

— TICP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06330753
Other study ID # 2024P000682
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date November 30, 2025

Study information
Verified date March 2024
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date November 30, 2025
Est. primary completion date May 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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 6-10 months
Secondary 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. 6- 10 months
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