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Clinical Trials/NCT04193033
NCT04193033CompletedNot Applicable

Evaluation of Implementing FLOW: Transitioning Stabilized Mental Health Patients to Management in Primary Care (PEC 19-302)

VA Office of Research and Development2 sites in 1 country9 target enrollmentStarted: July 6, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
9
Locations
2
Primary Endpoint
Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care

Study Overview

Brief Summary

Adequate access to mental health is one of the most important problems facing the VA and VISN 19. Mental health patients who are stabilized and recovered should be transitioned back to primary care to increase availability in mental health for new patients, and to signal to recovered patients that they are successfully recovered. Because there are currently no methods to identify who is recovered or tools and processes to assist in transitions, few patients 'graduate' mental health. The FLOW program consists of an algorithm to identify patients who are potentially appropriate for transition, a user-friendly online report to communicate this information to providers, materials to explain this process to patients and providers, and an electronic medical record (EMR) note template to document the transition. The investigators are partnering with VISN 19 to evaluate this program using a stepped wedge design with 9 sites randomly allocated into 3 steps in the wedge. Sites will receive an evidence-based implementation facilitation approach. The investigators will evaluate the number of patients transitioned, success of those transitions, and patient and provider satisfaction.

Detailed Description

Our study sites requested that we pause implementation due to clinical efforts and site disruption related to COVID-19. Date of study resumption is unclear.

Adequate access to mental health is one of the most important problems facing the VA and VISN 19. Mental health patients who are stabilized and recovered should be transitioned back to primary care to increase availability in mental health for new patients, and to signal to recovered patients that they are successfully recovered. Because there are currently no methods to identify who is recovered or tools and processes to assist in transitions, few patients 'graduate' mental health. The FLOW program consists of an algorithm to identify patients who are potentially appropriate for transition, a user-friendly online report to communicate this information to providers, materials to explain this process to patients and providers, and an electronic medical record (EMR) note template to document the transition. The investigators are partnering with VISN 19 to evaluate this program using a stepped wedge design with 9 sites randomly allocated into 3 steps in the wedge. Sites will receive an evidence-based implementation facilitation approach. The investigators will evaluate the number of patients transitioned, success of those transitions, and patient and provider satisfaction.

Specific aims for this proposal are:

  1. To evaluate the impact of FLOW, using the evaluation framework RE-AIM, including:

  2. Reach of the program: % of clinic patients transitioned to PC using FLOW

  3. Effectiveness: successful transition to primary care and impact on clinic access for future patients

  4. Adoption: percent of providers in the selected clinics transitioning patients to primary care

  5. Implementation: use of all FLOW components

  6. Maintenance: sustainment of FLOW after withdrawal of external facilitation

  7. To evaluate structural and process implementation factors, including organizational readiness to change, staffing levels, interservice agreements about care, leadership support, and internal facilitation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
None

Masking Description

Because this is a stepped wedge design QI clinical trial, masking is not feasible.

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • This study uses site-level randomization
  • Sites must be VA sites with substantial numbers of mental health patients
  • VA medical centers or large or very large community based outpatient clinics

Exclusion Criteria

  • Non-VA sites and CBOCs smaller than large

Outcomes

Primary Outcomes

Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care

Time Frame: Change from baseline to 12 months

Percent of mental health patients in each of the participating clinics who are transitioned to primary care through use of the FLOW intervention, based upon electronic medical record data documenting this transition

Effectiveness of Intervention's Impact on Clinic Access

Time Frame: Change from baseline to 12 months

Appointments freed up by FLOW consistent discharges from mental health clinics, by site

Implementation Fidelity to the Protocol

Time Frame: 12 months

Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist

Adoption: Percent of Mental Health Providers Who Use FLOW Intervention

Time Frame: 12 months

Percent of mental health providers who use the FLOW intervention for at least 3 patients, compared to the total number of mental health providers in the participating clinics

Secondary Outcomes

  • Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care(from 12-24 months)
  • Maintenance of Effectiveness of Intervention's Impact on Clinic Access(12-18 months)
  • Maintenance of Implementation Fidelity to the Protocol(12-24 months)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (2)

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