Evaluation of Implementing FLOW

VA Office of Research and Development

Status: Completed

Conditions: Mental Health

Treatments: Other: FLOW intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04193033

PEX 19-004

Details and patient eligibility

About

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.

Full 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:

   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.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

FLOW intervention

Experimental group

Description:

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.

Treatment:

Other: FLOW intervention

Waitlist until Time 2

No Intervention group

Description:

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.

Waitlist until Time 3

No Intervention group

Description:

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.