Evaluation of Implementing FLOW

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2022-09-30

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.

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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:

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

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

Conditions

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Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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

Study Groups

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FLOW intervention

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.

Group Type EXPERIMENTAL

FLOW intervention

Intervention Type OTHER

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.

Waitlist until Time 2

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Waitlist until Time 3

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FLOW intervention

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.

Intervention Type OTHER

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