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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)

This study is not yet open for participant recruitment.
Verified May 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02713217
First Posted: March 18, 2016
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Depressive Disorders Alcohol Use Disorders Other: Usual Care Other: Blended Telemedicine-Based Integrated Care

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Adapting and Implementing the Blended Collaborative Care Model in CBOCs

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 588
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: December 1, 2020
Estimated Primary Completion Date: June 15, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
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
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • The investigators will enroll Veterans who screen positive on routinely administered VA mental health screens for depressive disorders and alcohol use disorders 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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Mary K Bartnik, MA (501) 257-1702 Mary.Bartnik@va.gov
Contact: Amanda K Lunsford, MS (501) 257-1806 Amanda.Lunsford2@va.gov

Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR Not yet recruiting
North Little Rock, Arkansas, United States, 72114-1706
Contact: Mary K Bartnik, MA    501-257-1702    Mary.Bartnik@va.gov   
Contact: Amanda K Lunsford, MS    (501) 257-1806    Amanda.Lunsford2@va.gov   
Sub-Investigator: Dinesh Mittal, MD         
Sub-Investigator: Eva N Woodward, PhD         
Sub-Investigator: JoAnn E. Kirchner, MD         
Sub-Investigator: Karen L. Drummond, PhD         
Principal Investigator: Richard R. Owen, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Richard R. Owen, MD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02713217     History of Changes
Other Study ID Numbers: CRE 12-310
First Submitted: March 14, 2016
First Posted: March 18, 2016
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
depressive disorder
alcohol-related disorders
telemedicine
rural health
collaborative care

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Alcohol Drinking
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Drinking Behavior


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