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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03191929
Other study ID # 2011-8343
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date June 2015

Study information

Verified date June 2023
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assessed the potential of Health Information Technology (HIT) to improve the screening, diagnosis, and treatment of depression and post-traumatic stress among LEP Southeast Asians. Should this intervention be found to be effective, the principles of the HIT technology could be easily adapted for screening in other languages to increase the recognition and treatment of depression and PTSD in primary care settings.


Description:

The prevalence of depression in primary care is high. Primary care physicians serve as the initial point of contact for most patients with depression, yet it is estimated that only about half of the depressed patients who present for care are recognized and treated. Language barriers can further exacerbate this problem. Approximately 54 million people in the United States speak a language other than English at home and over 21 million are limited English-language proficient (LEP). Language barriers may result in less discussion about patients' mental health needs and fewer referrals to specialty mental health services. Recent advances in health information technology (HIT), however, may facilitate novel ways to screen for mental health problems among limited English proficient patients. The HIT intervention is a provider-level intervention that consists of four components: 1) web- based training for the providers; 2) multimedia electronic screening of patients for depression and PTSD; 3) immediate notification to the health care providers and integration with the patients' electronic health records (EHR); and 4) provider clinical decision support. In a randomized controlled trial in a primary care setting, we will assess the potential of a multi-component health information technology intervention to improve the screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder among LEP Southeast Asians. We will examine the usability and acceptability of this technology to patients with limited English skills and their providers. Finally, we will identify and evaluate potential facilitators and barriers to wide spread implementation and dissemination of the HIT intervention. This technology has the potential to be adapted and utilized for any group of limited English-language proficient (LEP) patients, regardless of their native language, and has the potential to be adapted for providers to aid in the recognition, diagnosis, and treatment of mental health problems in diverse primary care settings.


Recruitment information / eligibility

Status Completed
Enrollment 410
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
HIT Intervention
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.
Minimal Intervention Control Arm
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dara Sorkin

Outcome

Type Measure Description Time frame Safety issue
Primary Appropriate clinical detection of depression and/or PTSD The appropriate presence or absence of provider diagnosis of depression and/or PTSD in the patient electronic medical record. 12 weeks
Secondary Provider initiation of guideline mental health treatment and trauma informed care 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
Secondary Patient outcomes (at 12 weeks post-baseline visit) for depression and/or PTSD 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
Secondary Patients' evaluation of the overall quality of care 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
Secondary Patients' level of involvement in decision-making related to their care 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
Secondary Patients' trust in their provider 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
Secondary Patients' perceptions of being treated as an equal partner in their care 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
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