Evaluation of Implementing FLOW

Study Overview
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Brief Summary
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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
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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: To evaluate the impact of FLOW, using the evaluation framework RE-AIM, including: Reach of the program: % of clinic patients transitioned to PC using FLOW Effectiveness: successful transition to primary care and impact on clinic access for future patients Adoption: percent of providers in the selected clinics transitioning patients to primary care Implementation: use of all FLOW components Maintenance: sustainment of FLOW after withdrawal of external facilitation To evaluate structural and process implementation factors, including organizational readiness to change, staffing levels, interservice agreements about care, leadership support, and internal facilitation.

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

Conditions
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Mental Health

Intervention / Treatment
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* Other: FLOW intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomization will be at the site level. All 9 sites will receive the intervention, using a stepped wedge design. Sites will be randomly allocated to one of three cohorts, and all sites within a cohort will receive the intervention at the same time. Cohort start dates will be offset by three months to allow examination of time effects.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLOW intervention<br>Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process. | Other: FLOW intervention<br>* The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.<br>|
| No Intervention: Waitlist until Time 2<br>Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2. | |
| No Intervention: Waitlist until Time 3<br>Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach: Percent of specialty mental health patients transitioned to primary care | 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 | Change from baseline to 12 months | 
| Effectiveness of intervention's impact on clinic access | Change in the VA publically reported metric Percent of patients receiving an appointment within 7 days of the requested date from baseline to 12 months | Change from baseline to 12 months | 
| Adoption: Percent of mental health providers who use FLOW intervention | Percent of mental health providers who use the FLOW intervention for at least 1 patient, compared to the total number of mental health providers in the participating clinics | 12 months | 
| Implementation fidelity to the protocol | Percent if all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of Effectiveness of intervention's impact on clinic access | Change in the VA publically reported metric Percent of patients receiving an appointment within 7 days of the requested date from 12 to 24 months | 12-24 months | 
| Maintenance of Implementation fidelity to the protocol | Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist, from 12 to 24 months | 12-24 months | 
| Maintenance of Adoption: percentage of mental health providers who use FLOW intervention | Percent of mental health providers who use the FLOW intervention for at least 1 patient, compared to the total number of mental health providers in the participating clinics, from 12-24 months | 12-24 months | 
| Maintenance of Reach: percentage of specialty mental health patients transitioned to primary care | 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, during the maintenance period | from 12-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health