NCT03191929

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

3.8 years

First QC Date

June 9, 2017

Last Update Submit

June 30, 2023

Conditions

Keywords

DepressionPost-traumatic Stress DisorderHealth Information Technology (HIT)Primary Care ProviderMental Health Screening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Provider initiation of guideline mental health treatment and trauma informed care

    12 weeks

  • Patient outcomes (at 12 weeks post-baseline visit) for depression and/or PTSD

    12 weeks

  • Patients' evaluation of the overall quality of care

    12 weeks

  • Patients' level of involvement in decision-making related to their care

    12 weeks

  • Patients' trust in their provider

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

HIT Intervention Arm

EXPERIMENTAL

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.

Other: HIT Intervention

Minimal Intervention Control Arm

ACTIVE COMPARATOR

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.

Other: Minimal Intervention Control Arm

Interventions

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.

HIT Intervention 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.

Minimal Intervention Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cambodian patients over age 18 were included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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(Suppl 6 2):S190-S196. doi: 10.1097/MLR.0000000000001036.

MeSH Terms

Conditions

DepressionStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Dara H. Sorkin, Ph.D.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 19, 2017

Study Start

August 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share