Depressive DisordersTele-PCMHINCT02713217
Implementing a Blended Care Model That Integrates Mental Healthcare and Primary Care Using Telemedicine and Care Management for Patients With Depression or Alcohol Use Disorder in Small Primary Care Clinics
An observational study of Depressive Disorders and Alcohol Use Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Integrating mental health treatments into the primary care delivered at Community Based Outpatient Clinics(CBOCs) that are geographically accessible to rural Veterans is a major priority for the Department of Veterans Affairs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorders, Alcohol Use Disorders, Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- Blended Telemedicine-Based Integrated Care
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 1 Aug 2020
- Phase
- Observational
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
Study population: Patients will be Veterans receiving care at 6 Community-Based Outpatient Clinics (primary care clinics) affiliated with the Central Arkansas Veterans Healthcare System or the Overton Brooks VA Medical Center.
Who may be able to join
- The investigators will enroll Veterans who screen positive on routinely administered VA mental health screens for depressive disorders, alcohol use disorders, and PTSD at the 6 study CBOCs.
Who cannot join
- Patients receiving specialty mental health treatment in the 6 months prior to recruitment and those who have a diagnosis of PTSD
- Those with a diagnosis of substance dependence
- Those with a psychotic disorder diagnosis:
- schizophrenia
- bipolar disorder
- other psychotic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, 72114-1706
About this study
Official title: Adapting and Implementing the Blended Collaborative Care Model in CBOCs
Integrating mental health treatments into the primary care delivered at Community Based Outpatient Clinics(CBOCs) that are geographically accessible to rural Veterans is a major priority for the Department of Veterans Affairs. However, there is no scientific evidence that integrating mental health and primary care is clinically effective at smaller CBOCs that have limited mental health staffing. The goal of this proposed project is to implement a "blended" combination of integrated care models that have been adapted for smaller CBOCs using telemedicine technologies, and evaluate the acceptability and effectiveness of the blended, telemedicine-based, integrated care model. If clinical outcomes are improved compared to usual care, findings will be used to justify and facilitate the implementation of this telemedicine-based integrated care model at smaller CBOCs in order to increase rural Veterans' access to effective mental health treatments.
Read the detailed description
Background: Providing mental health care to rural Veterans in geographically accessible Community Based Outpatient Clinics (CBOCs) is a major priority of the Office of Rural Health. Likewise, integrating mental health into primary care is one of the highest priorities of the Office of Mental Health Services and the Office of Mental Health Operations. The Uniform Mental Health Services Handbook mandates the blending of the two predominant, evidence-based models of integrated care (the Care Management model and the Co-Located model) at VAMCs, very large CBOCs, and large CBOCs. Because there is no scientific evidence to support its implementation, the "Blended model" is not mandated at medium CBOCs or small CBOCs that serve rural Veterans. At most smaller CBOCs, on-site mid-level providers and/or off-site tele-psychiatrists and tele-psychologists deliver traditional referral-based specialty treatment (Referral model) rather than integrated care.
Objective: This project contributes to Specific Aim 3 (Test clinical interventions to improve quality and outcomes of mental health care at CBOCs) of the Little Rock CREATE application. The goal of this proposed Hybrid Type 2 pragmatic effectiveness-implementation trial is to generate the scientific evidence needed to justify the national dissemination of the Blended model adapted using telemedicine technologies to accommodate the clinical context of smaller CBOCs that lack on-site psychiatrists and PhD psychologists. The resulting Telemedicine Blended model will be compared to usual care (Referral model) in a pragmatic trial, where the intervention will be delivered via interactive video by centrally located clinical staff and fidelity will be monitored but not controlled. Specific Aim 1: Use an expert panel comprised of clinical providers and managers who are applying telemedicine to provide a Blended model for CBOCs lacking on-site PhD psychologists and psychiatrists to document the core components of a Telemedicine Blended model and using a PDSA process, implement this model in six CBOCs. Specific Aim 2: Conduct a Hybrid Type 2 pragmatic effectiveness-implementation trial of the adapted Telemedicine Blended model by assessing RE-AIM outcomes including: provider Reach into the patient population, Effectiveness at improving clinical outcomes, Adoption by providers and Implementation Fidelity.
Methods: In conjunction with national, regional and local partners, including providers and managers who have experience with the Telemedicine Blended model, the Blended model will be adapted for smaller CBOCs using telemedicine technologies and pilot tested to generate a standardized treatment protocol. We will use a stepped wedge design with randomization of sites to sequential implementation steps, and CBOC patients who screen positive for depression or alcohol disorders will be recruited and consented to participate in the Hybrid Type 2 pragmatic effectiveness-implementation trial. Data about Reach and Adoption will be obtained from the Corporate Data Warehouse. Data about Implementation Fidelity will be obtained from chart review. Data about clinical Effectiveness will be obtained from telephone survey.
Impact: If the Telemedicine Blended model improves clinical outcomes compared to usual care, results will be used to justify and facilitate the implementation of the Telemedicine Blended model at smaller CBOCs.
- Being tested
- Usual Care, Blended Telemedicine-Based Integrated Care
- Keywords
- depressive disorder, alcohol-related disorders, telemedicine, rural health, collaborative care, post-traumatic stress disorder (PTSD)
- Medical subject headings
- Depressive Disorder, Alcoholism, Stress Disorders, Post-Traumatic, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Also called Pre-Implementation
This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care.
Blended Telemedicine-Based Integrated CareOther
Also called Post-Implementation
This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation Cohort | Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs. Receives: Other: Usual Care | |
| Post-Implementation Cohort | Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model. Receives: Other: Blended Telemedicine-Based Integrated Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VR-12 Mental Component Summary Scores
Change in overall mental health functioning from study enrollment (after screening positive for depressive disorder or alcohol use disorder) to six-month follow-up on the Mental Component Summary scale of the Veterans Rand 12-item Health Survey. Measure Description: The Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) is a normed scale, presented as a T-score that is standardized to the US population. The population mean MCS score is 50 and standard deviation is 10, with scores ranging from 0-100. A higher (positive) change score represents greater improvement in mental health-related quality of life from study enrollment to follow-up. The VR-12 was developed from the Veterans RAND 36-Item Health Survey (VR-36), which was developed from the Medical Outcomes Study RAND SF-36(TM) Version 1.0.
Measured: Six months
Secondary outcomes (2)
Change in PHQ-9 Scores
Change in depressive symptoms as measured by Patient Health Questionnaire (PHQ-9) from study enrollment to six-month follow-up, for patients screening positive for depressive disorders at baseline. The possible range of scores on the PHQ-9 is 0-27, with higher scores indicating more severe depressive symptoms. A negative change score represents improvement in depressive symptoms.
Measured: Six months
Change in AUDIT-C Scores
Change in alcohol use symptoms from study enrollment to six-month follow-up, for patients screening positive for alcohol use disorders at baseline. The analysis used the Alcohol Use Disorders Identification Test (AUDIT-C) Total Score. The possible range of scores is 0-12, with higher scores indicating greater alcohol use.
Measured: Baseline, Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start25 Jul 2017
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard R. Owen, MD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, ARJoAnn E. Kirchner, MD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713217
- Sponsor's protocol ID
- CRE 12-310
- Acronym
- Tele-PCMHI
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2016
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Owen RR, Woodward EN, Drummond KL, Deen TL, Oliver KA, Petersen NJ, Meit SS, Fortney JC, Kirchner JE. Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design. Implement Sci. 2019 Mar 21;14(1):33. doi: 10.1186/s13012-019-0875-5.
PubMed 30898129Bauer MS, Miller C, Kim B, Lew R, Weaver K, Coldwell C, Henderson K, Holmes S, Seibert MN, Stolzmann K, Elwy AR, Kirchner J. Partnering with health system operations leadership to develop a controlled implementation trial. Implement Sci. 2016 Feb 24;11:22. doi: 10.1186/s13012-016-0385-7.
PubMed 26912342