Evaluation of Implementing FLOW (FLOW)

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health
• Intervention / Treatment: Other: FLOW intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center, Houston, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Natalie E Hundt, PhD, Michael E. DeBakey VA Medical Center, Houston, TX

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: mental health
• Other Study ID Numbers: PEX 19-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This QI project uses site-level randomization and a stepped wedge design. Individual participants are not recruited into the study and do not provide informed consent. The quality improvement intervention is rolled out across sites, and the primary outcomes include access to care, which data are freely available to all VA investigators via the VA administrative and clinical databases.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No