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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

Adapting and Implementing the Blended Collaborative Care Model in CBOCs

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02713217
Acronym
Tele-PCMHI
Enrollment
318
Registered
2016-03-18
Start date
2017-07-25
Completion date
2020-08-01
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERUsual 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.

OTHERBlended 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in VR-12 Mental Component Summary ScoresSix monthsChange 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.

Secondary

MeasureTime frameDescription
Change in PHQ-9 ScoresSix monthsChange 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.
Change in AUDIT-C ScoresBaseline, Six monthsChange 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRichard R. Owen, MD

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

PRINCIPAL_INVESTIGATORJoAnn E. Kirchner, MD

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

Participant flow

Participants by arm

ArmCount
Usual Care (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. 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.
279
Blended Telemedicine-Based 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. 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.
39
Total318

Baseline characteristics

CharacteristicTotalUsual Care (Pre-Implementation) CohortBlended Telemedicine-Based Care (Post-Implementation) Cohort
Age, Continuous53.0 years
STANDARD_DEVIATION 15
53.6 years
STANDARD_DEVIATION 14.8
48.9 years
STANDARD_DEVIATION 16.6
AUDIT-C Total Score3.8 units on a scale
STANDARD_DEVIATION 3.4
3.6 units on a scale
STANDARD_DEVIATION 3.5
4.6 units on a scale
STANDARD_DEVIATION 2.9
BRFSS Tobacco Use119 Participants109 Participants10 Participants
Clinical Alcohol Screening Test - Positive128 Participants106 Participants22 Participants
Clinical Depression Screen Positive133 Participants116 Participants17 Participants
Clinical PTSD Screening - Positive106 Participants105 Participants1 Participants
CSQ-827.0 units on a scale27.0 units on a scale28.0 units on a scale
Education
College Degree or More
72 Participants54 Participants18 Participants
Education
High School or Less
115 Participants107 Participants8 Participants
Education
Some College
131 Participants118 Participants13 Participants
Employment
Full-Time or Part-Time
119 Participants98 Participants21 Participants
Employment
Other
120 Participants108 Participants12 Participants
Employment
Retired
79 Participants73 Participants6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants6 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
310 Participants272 Participants38 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
GAD-79.3 units on a scale
STANDARD_DEVIATION 6
9.1 units on a scale
STANDARD_DEVIATION 6
10.4 units on a scale
STANDARD_DEVIATION 6.1
Hoge Barriers Assessment33.8 units on a scale
STANDARD_DEVIATION 8.9
33.9 units on a scale
STANDARD_DEVIATION 8.8
33.1 units on a scale
STANDARD_DEVIATION 9.9
Jenkins Sleep Scale14.0 units on a scale14.0 units on a scale16.0 units on a scale
Marital Status187 Participants164 Participants23 Participants
Non-VA Health Insurance Status184 Participants163 Participants21 Participants
Pain Scale5.1 units on a scale
STANDARD_DEVIATION 2.7
5.1 units on a scale
STANDARD_DEVIATION 2.7
4.8 units on a scale
STANDARD_DEVIATION 2.9
PCL-530.3 units on a scale
STANDARD_DEVIATION 17.6
30.4 units on a scale
STANDARD_DEVIATION 17.6
29.2 units on a scale
STANDARD_DEVIATION 17.4
PHQ-911.2 units on a scale
STANDARD_DEVIATION 6.3
11.2 units on a scale
STANDARD_DEVIATION 6.3
11.3 units on a scale
STANDARD_DEVIATION 6.3
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
100 Participants93 Participants7 Participants
Race (NIH/OMB)
More than one race
17 Participants17 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants0 Participants
Race (NIH/OMB)
White
197 Participants165 Participants32 Participants
Readiness Ruler
Readiness 1
6.0 units on a scale6.0 units on a scale7.0 units on a scale
Readiness Ruler
Readiness 2
8.0 units on a scale8.0 units on a scale8.0 units on a scale
Readiness Ruler
Readiness 3
7.0 units on a scale7.0 units on a scale8.0 units on a scale
Region of Enrollment
United States
318 Participants279 Participants39 Participants
Severity Measure for Panic - Adult11.9 units on a scale
STANDARD_DEVIATION 8.6
12.1 units on a scale
STANDARD_DEVIATION 8.6
10.6 units on a scale
STANDARD_DEVIATION 8.6
Sex: Female, Male
Female
29 Participants22 Participants7 Participants
Sex: Female, Male
Male
289 Participants257 Participants32 Participants
VR-12 MCS39.5 units on a scale
STANDARD_DEVIATION 13.5
39.7 units on a scale
STANDARD_DEVIATION 13.5
38.2 units on a scale
STANDARD_DEVIATION 13.7
VR-12 PCS33.2 units on a scale
STANDARD_DEVIATION 13.6
32.7 units on a scale
STANDARD_DEVIATION 13.6
36.8 units on a scale
STANDARD_DEVIATION 13.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 2790 / 39
other
Total, other adverse events
0 / 2790 / 39
serious
Total, serious adverse events
0 / 2790 / 39

Outcome results

Primary

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.

Time frame: Six months

Population: The number of participants analyzed for each cohort is somewhat less than the number of total participants in each group (1) because of loss to follow-up and (2) because participants who only screened positive for PTSD were not included in this analysis.

ArmMeasureValue (MEAN)Dispersion
Usual Care (Pre-Implementation) CohortChange in VR-12 Mental Component Summary Scores2.9 score on a scaleStandard Deviation 11.8
Blended Telemedicine-Based Care (Post-Implementation) CohortChange in VR-12 Mental Component Summary Scores5.1 score on a scaleStandard Deviation 9.6
Secondary

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.

Time frame: Baseline, Six months

Population: Participants are included in this analysis if they screened positive for alcohol use disorder (clinical screen) before enrollment. The number of participants analyzed is lower than the total enrolled in the study because many participants did not screen positive for alcohol use disorder. At 6-month follow-up assessment, some participants were lost to follow-up.

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Pre-Implementation) CohortChange in AUDIT-C ScoresBaseline assessment6.8 units on a scaleStandard Deviation 2.8
Usual Care (Pre-Implementation) CohortChange in AUDIT-C Scores6-month follow-up assessment6.4 units on a scaleStandard Deviation 2.7
Blended Telemedicine-Based Care (Post-Implementation) CohortChange in AUDIT-C ScoresBaseline assessment6.5 units on a scaleStandard Deviation 1.7
Blended Telemedicine-Based Care (Post-Implementation) CohortChange in AUDIT-C Scores6-month follow-up assessment6.1 units on a scaleStandard Deviation 2
Secondary

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.

Time frame: Six months

Population: The numbers of participants analyzed in each cohort for this measure is less than the total number of participants (1) because this analysis only included participants who had screened positive for depression and (2) because of loss to follow-up.

ArmMeasureValue (MEAN)Dispersion
Usual Care (Pre-Implementation) CohortChange in PHQ-9 Scores-2.3 score on a scaleStandard Deviation 6
Blended Telemedicine-Based Care (Post-Implementation) CohortChange in PHQ-9 Scores-3.2 score on a scaleStandard Deviation 3.8
Other Pre-specified

Adoption of Intervention by Primary Care Providers

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.

Time frame: 12-24 months

Other Pre-specified

Reach of Intervention

Proportion of patients having any mental health encounter in the six month follow-up period.

Time frame: Six months

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026