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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

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as enrolling by invitation.

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 31 studies in Trauma and Stressor Related Disorders with a site in United States — 20 open to participants now, 20 under way, 1 of them phase 3. Trauma and Stressor Related Disorders · United States.

Planned enrollment
5th of 30
200 · median 47
Started
2025
with 6 others
No phase
25 of 31
19 open now
Primary completion
2026-05
later than 3 of 19 live
Registered
14th of 31
by date
Lead sponsor
1 of 31
Brigham and Women's Hospital

Among the 31 studies in Trauma and Stressor Related Disorders with a site in United States, this one is the 5th largest by planned enrollment of the 30 interventional ones that give a count, is one of 7 that started in 2025, is one of 25 with no phase, reaches primary completion later than 3 of the 19 other live ones, and was the 14th registered.

Trauma and Stressor Related Disorders

54 studies on the registry are indexed under Trauma and Stressor Related Disorders; 29 are open to participants now.

Browse Trauma and Stressor Related Disorders studies →

Open to participants now

20 of the 31 studies in Trauma and Stressor Related Disorders with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 23 Trauma and Stressor Related Disorders studies recruiting now, 8 (35%) set no upper age limit and 10 (43%) stop at 75 or younger; 4 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

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.

03

Conditions studied

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

Keywords

  • trauma
  • violence
  • abuse
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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.

06

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

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for May 2026, 15 months after the start.

Of 32 interventional studies with no phase under Trauma and Stressor Related Disorders, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 55. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2024
First posted
Mar 26, 2024
StartActual
Jan 17, 2025
Primary completionEst.
May 15, 2026
CompletionEst.
Nov 30, 2026
Last update
Nov 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06330753
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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