Clinical trial NCT04193033: Evaluation of Implementing FLOW
Official title: Evaluation of Implementing FLOW: Transitioning Stabilized Mental Health Patients to Management in Primary Care (PEC 19-302)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: mental health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-12-10
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

   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.

Eligibility criteria: 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

Primary outcomes:
measure: Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care
timeFrame: Change from baseline to 12 months
measure: Effectiveness of Intervention's Impact on Clinic Access
timeFrame: Change from baseline to 12 months
measure: Adoption: Percent of Mental Health Providers Who Use FLOW Intervention
timeFrame: 12 months
measure: Implementation Fidelity to the Protocol
timeFrame: 12 months
Secondary outcomes:
measure: Maintenance of Effectiveness of Intervention's Impact on Clinic Access
timeFrame: 12-18 months
measure: Maintenance of Implementation Fidelity to the Protocol
timeFrame: 12-24 months
measure: Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care
timeFrame: from 12-24 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Natalie E Hundt, PhD
role: PRINCIPAL_INVESTIGATOR
References: