DepressionNCT03191929
Depression Screening in Primary Care: Using HIT for Patients With Limited English
A study testing HIT Intervention in people with Depression and Post-Traumatic Stress Disorder, run by Dara Sorkin.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Post-Traumatic Stress Disorder
- What is being tested?
- HIT Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cambodian patients over age 18 were included.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Depression, Post-Traumatic Stress Disorder
- Being tested
- HIT Intervention, Minimal Intervention Control Arm
- Keywords
- Depression, Post-traumatic Stress Disorder, Health Information Technology (HIT), Primary Care Provider, Mental Health Screening
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIT InterventionOther
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 ArmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Minimal Intervention Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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).
Measured: 12 weeks
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?"
Measured: 12 weeks
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?"
Measured: 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study startAug 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dara Sorkin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dara Sorkin, University of California, Irvine
- Investigators
- Dara H. Sorkin, Ph.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191929
- Sponsor's protocol ID
- 2011-8343
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2017
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31095060
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Screening in Primary Care: Using HIT for Patients With Limited English
- ClinicalTrials.gov ID
- NCT03191929
- Acronym / sponsor ID
- 2011-8343
- Conditions
- Depression, Post-Traumatic Stress Disorder
- Keywords
- Depression, Post-traumatic Stress Disorder, Health Information Technology (HIT), Primary Care Provider, Mental Health Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Dara SorkinUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIT Intervention Arm | Experimental | Other: HIT InterventionThe 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. |
| Minimal Intervention Control Arm | Active comparator | Other: Minimal Intervention Control ArmThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cambodian patients over age 18 were included.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIT InterventionPatients 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. | Other | HIT Intervention Arm |
| Minimal Intervention Control ArmPatients 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. | Other | Minimal Intervention Control Arm |
Primary outcome
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.
6 secondary outcomes
Provider initiation of guideline mental health treatment and trauma informed care
Time frame: 12 weeks
Patient outcomes (at 12 weeks post-baseline visit) for depression and/or PTSD
Time frame: 12 weeks
Patients' evaluation of the overall quality of care
Time frame: 12 weeks
Patients' level of involvement in decision-making related to their care
Time frame: 12 weeks
Patients' trust in their provider
Time frame: 12 weeks
Patients' perceptions of being treated as an equal partner in their care
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 31095060Sorkin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dara H. Sorkin, Ph.D. principal investigator
University of California, Irvine
Questions about this trial
What is this clinical trial studying?
A study testing HIT Intervention in people with Depression and Post-Traumatic Stress Disorder, run by Dara Sorkin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate clinical detection of depression and/or PTSD (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.