- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03191929
Depression Screening in Primary Care: Using HIT for Patients With Limited English
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cambodian patients over age 18 were included.
Exclusion Criteria:
- Patients with severe visual/hearing impairments, major psychiatric disorders such as bipolar disorder or schizophrenia, and/or life-threatening illness, which limited their ability to consent to the study were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIT Intervention Arm
The Health Information Technology Intervention Study Arm consisted of: 1) web-based tutorial on delivering trauma-informed care, 2) Multi-media mental health risk assessment, 3) Immediate provider notification, which included flagging patients' scores that met criteria for symptoms of depression and/or PTSD, 4) subsequent integration into the patient electronic medical record, and 5) Clinical decision support adapted from the Harvard Program in Refugee Trauma.
|
Patients in the HIT intervention completed a multi-media, culturally adapted, mental health risk assessment tool in their preferred language prior to their baseline health care visit with their primary care provider. Patients' scores were transmitted to the provider prior to their clinic visit. Providers in the HIT intervention received a web-based training developed by the Harvard Program in Refugee Trauma to train providers in delivering culturally competent, trauma-informed care to address mental health problems and other trauma-related medical issues in patients who experienced extreme war trauma. Providers also received ongoing clinical decision support through a mobile application to support the diagnosis and initiation of treatment for depression and/or PTSD. |
Active Comparator: Minimal Intervention Control Arm
The Minimal Intervention Control Arm consisted of: 1) web-based tutorial on delivering culturally competent health care in general, 2) Multi-media mental health risk assessment, 3) Provider notification only in the event that patients' scores evidenced symptoms of being at risk to harm either themselves or others.
|
Patients in the Minimal Intervention Control Arm completed a multi-media, culturally adapted, mental health risk assessment tool in their preferred language prior to their baseline health care visit with their primary care provider; however, patients' scores in the Minimal Intervention Control Arm were only transmitted to the provider prior to their clinic visit if they showed evidence of being at risk to harm either themselves or others. Providers in the Minimal Intervention Control Arm completed the online tutorial, "A physician's practical guide to culturally competent care," which was provided by The Office of Minority Health, US Department of Health and Human Services Website. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appropriate clinical detection of depression and/or PTSD
Time Frame: 12 weeks
|
The appropriate presence or absence of provider diagnosis of depression and/or PTSD in the patient electronic medical record.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider initiation of guideline mental health treatment and trauma informed care
Time Frame: 12 weeks
|
The study will examine whether providers in the HIT intervention group were more likely to initiate guideline mental health treatment and trauma-informed care relative to the control group.
The initiation of guideline mental health treatment and trauma-informed care will be examined by obtaining providers' documentation and treatment plans for each patient's clinic visits over 12 weeks.
Providers will receive credit for initiating guideline mental health treatment if they initiated one or more of the following recommendations: 1) Pharmacotherapy discussion and prescription, 2) watchful waiting, and 3) referral to mental health specialist.
Providers will receive credit for initiating trauma-informed care if the provider engaged in one or more of the following: 1) conducted a risk assessment of patients' depression or PTSD status, 2) discussed the trauma story with the patient, 3) asked patients if they wanted to improve their well-being, and/or 4) assessed psychiatric symptoms.
|
12 weeks
|
Patient outcomes (at 12 weeks post-baseline visit) for depression and/or PTSD
Time Frame: 12 weeks
|
The study will examine whether patients' self-reported outcomes (12 weeks post-baseline visit) for depression and/or PTSD will be improved by the HIT intervention.
Depression and PTSD status will be assessed by the HSC and HTQ, which was readministered at 12 weeks post-baseline.
|
12 weeks
|
Patients' evaluation of the overall quality of care
Time Frame: 12 weeks
|
Patients' evaluation of their overall quality of care will be assessed using a single item that asked them to rate the quality of care they received in the past 12 months.
Ratings were made on a 5-point scale (1 = Poor, 5 = Excellent).
|
12 weeks
|
Patients' level of involvement in decision-making related to their care
Time Frame: 12 weeks
|
Patients' level of involvement in decision-making related to their care will be assessed using the Participatory Decision Making Scale (PDM-7).
Ratings were made on a 5-point Likert scale (1=Never/None of the time; 5=Very often/All of the time).
A sample item included "How often do the doctors that take care of you offer you choices in your medical care?"
|
12 weeks
|
Patients' trust in their provider
Time Frame: 12 weeks
|
Patients' trust in their provider will be assessed using five items from the Trust in Physicians Scale.
Ratings were made on a 5-point Likert scale (1=Never, 5=Always).
A sample item included "How often do you feel you trust your doctor's judgments about your medical care?"
|
12 weeks
|
Patients' perceptions of being treated as an equal partner in their care
Time Frame: 12 weeks
|
Patients' perceptions of being treated as an equal partner by their provider will be assessed by a single item, "Do the doctors who care for you make an effort to treat you like an equal partner?"
Ratings were made on a 5-point scale (1=Definitely Yes; 5=Definitely No)
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dara H. Sorkin, Ph.D., University of California, Irvine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-8343
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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