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 (Tele-PCMHI)
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|ClinicalTrials.gov Identifier: NCT02713217|
Recruitment Status : Enrolling by invitation
First Posted : March 18, 2016
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment|
|Depressive Disorders Alcohol Use Disorders Post-traumatic Stress Disorder (PTSD)||Other: Usual Care Other: Blended Telemedicine-Based Integrated Care|
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.
|Study Type :||Observational|
|Estimated Enrollment :||588 participants|
|Official Title:||Adapting and Implementing the Blended Collaborative Care Model in CBOCs|
|Actual Study Start Date :||July 25, 2017|
|Estimated Primary Completion Date :||July 24, 2020|
|Estimated Study Completion Date :||February 1, 2021|
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
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.
Other Name: Pre-Implementation
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
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.
Other Name: Post-Implementation
- Change in SF-12V Mental Health Composite Scale scores [ Time Frame: Six months ]Change in overall mental health functioning from study enrollment (after screening positive for depressive disorder or alcohol use disorder) to six-month follow-up.
- Change in PHQ-9 scores [ Time Frame: Six months ]Change in depressive symptoms as measured by PHQ-9 from study enrollment to six-month follow-up, for patients screening positive for depressive disorders at baseline.
- Change in AUDIT-C scores [ Time Frame: Six months ]Change in alcohol use symptoms from study enrollment to six-month follow-up, for patients screening positive for alcohol use disorders at baseline.
- Adoption of intervention by primary care providers [ Time Frame: 12-24 months ]Proportion of primary care providers with at least one patient with a Primary Care-Mental Health Integration encounter following implementation of the blended, integrated care model. The time frame is variable due to the stepped wedge design.
- Reach of intervention [ Time Frame: Six months ]Proportion of patients having any mental health encounter in the six month follow-up period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713217
|United States, Arkansas|
|Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|
|North Little Rock, Arkansas, United States, 72114-1706|
|Principal Investigator:||Richard R. Owen, MD||Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|