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Depression Screening in Primary Care: Using HIT for Patients With Limited English

Primary Purpose

Depression, Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HIT Intervention
Minimal Intervention Control Arm
Sponsored by
Dara Sorkin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Post-traumatic Stress Disorder, Health Information Technology (HIT), Primary Care Provider, Mental Health Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HIT Intervention Arm

    Minimal Intervention Control Arm

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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).
    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?"
    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?"
    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)

    Full Information

    First Posted
    June 9, 2017
    Last Updated
    June 30, 2023
    Sponsor
    Dara Sorkin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03191929
    Brief Title
    Depression Screening in Primary Care: Using HIT for Patients With Limited English
    Official Title
    Depression Screening in Primary Care: Using HIT for Patients With Limited English
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dara Sorkin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Post-Traumatic Stress Disorder
    Keywords
    Depression, Post-traumatic Stress Disorder, Health Information Technology (HIT), Primary Care Provider, Mental Health Screening

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    410 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HIT Intervention Arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Minimal Intervention Control Arm
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    HIT Intervention
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Minimal Intervention Control Arm
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Appropriate clinical detection of depression and/or PTSD
    Description
    The appropriate presence or absence of provider diagnosis of depression and/or PTSD in the patient electronic medical record.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Provider initiation of guideline mental health treatment and trauma informed care
    Description
    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.
    Time Frame
    12 weeks
    Title
    Patient outcomes (at 12 weeks post-baseline visit) for depression and/or PTSD
    Description
    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.
    Time Frame
    12 weeks
    Title
    Patients' evaluation of the overall quality of care
    Description
    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).
    Time Frame
    12 weeks
    Title
    Patients' level of involvement in decision-making related to their care
    Description
    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?"
    Time Frame
    12 weeks
    Title
    Patients' trust in their provider
    Description
    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?"
    Time Frame
    12 weeks
    Title
    Patients' perceptions of being treated as an equal partner in their care
    Description
    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)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dara H. Sorkin, Ph.D.
    Organizational Affiliation
    University of California, Irvine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31095060
    Citation
    Sorkin DH, Rizzo S, Biegler K, Sim SE, Nicholas E, Chandler M, Ngo-Metzger Q, Paigne K, Nguyen DV, Mollica R. Novel Health Information Technology to Aid Provider Recognition and Treatment of Major Depressive Disorder and Posttraumatic Stress Disorder in Primary Care. Med Care. 2019 Jun;57 Suppl 6 Suppl 2:S190-S196. doi: 10.1097/MLR.0000000000001036.
    Results Reference
    derived

    Learn more about this trial

    Depression Screening in Primary Care: Using HIT for Patients With Limited English

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