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

NCT02713217 | Completed Results

• 1 other identifier: CRE 12-310
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depressive Disorders; Alcohol Use Disorders; Post-traumatic Stress Disorder (PTSD)

Keywords

depressive disorder; alcohol-related disorders; telemedicine; rural health; collaborative care; post-traumatic stress disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Six months

Secondary Outcomes (2)

• Change in PHQ-9 Scores

  Six months

• Change in AUDIT-C Scores

  Baseline, Six months

Other Outcomes (2)

• Adoption of Intervention by Primary Care Providers

  12-24 months

• Reach of Intervention

  Six months

Study Arms (2)

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.

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.

Other: Blended Telemedicine-Based Integrated Care

Interventions

Usual Care OTHER

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.

Also known as: Pre-Implementation

Pre-Implementation Cohort

Blended Telemedicine-Based Integrated Care OTHER

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.

Also known as: Post-Implementation

Post-Implementation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

North Little Rock, Arkansas, 72114-1706, United States

Location

Related Publications (2)

• 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.

  PMID: 30898129 RESULT

• Bauer 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.

  PMID: 26912342 RESULT

MeSH Terms

Conditions

Depressive Disorder; Alcoholism; Stress Disorders, Post-Traumatic; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Richard R. Owen, MD
• Organization: Central Arkansas Veterans Healthcare System

richard.owen2@va.gov

5012574802

Study Officials

• Richard R. Owen, MD

  Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

  PRINCIPAL INVESTIGATOR

• JoAnn E. Kirchner, MD

  Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 18, 2016
• Study Start: July 25, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 27, 2026
• Results First Posted: July 18, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)