- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06330753
Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan (TICP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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). |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Trauma Informed Care Plans
Time Frame: 6-10 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention Appropriateness of Trauma-Informed Care plans
Time Frame: 6-10 months
|
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
|
Feasibility of the trauma-informed care plans
Time Frame: 6- 10 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024P000682
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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