Clinical trial NCT02713217: 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
Official title: Adapting and Implementing the Blended Collaborative Care Model in CBOCs
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-03-18
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in VR-12 Mental Component Summary Scores
timeFrame: Six months
Secondary outcomes:
measure: Change in PHQ-9 Scores
timeFrame: Six months
measure: Change in AUDIT-C Scores
timeFrame: Baseline, Six months
Other outcomes:
measure: Adoption of Intervention by Primary Care Providers
timeFrame: 12-24 months
measure: Reach of Intervention
timeFrame: Six months
Locations:
city: North Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
state: Arkansas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Richard R. Owen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: JoAnn E. Kirchner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.