Evaluation of Implementing FLOW

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04193033
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 26.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health	Other: FLOW intervention	N/A

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:

2. Reach of the program: % of clinic patients transitioned to PC using FLOW

3. Effectiveness: successful transition to primary care and impact on clinic access for future patients

4. Adoption: percent of providers in the selected clinics transitioning patients to primary care

5. Implementation: use of all FLOW components

6. Maintenance: sustainment of FLOW after withdrawal of external facilitation

7. To evaluate structural and process implementation factors, including organizational readiness to change, staffing levels, interservice agreements about care, leadership support, and internal facilitation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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)
• Masking Description: Because this is a stepped wedge design QI clinical trial, masking is not feasible.
• Primary Purpose: Health Services Research
• Official Title: Evaluation of Implementing FLOW: Transitioning Stabilized Mental Health Patients to Management in Primary Care (PEC 19-302)
• Actual Study Start Date: Jul 6, 2020
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Reach: Percent of specialty mental health patients transitioned to primary care [Change from baseline to 12 months]

   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

2. Effectiveness of intervention's impact on clinic access [Change from baseline to 12 months]

   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

3. Adoption: Percent of mental health providers who use FLOW intervention [12 months]

   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

4. Implementation fidelity to the protocol [12 months]

   Percent if all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist

Secondary Outcome Measures

1. Maintenance of Effectiveness of intervention's impact on clinic access [12-24 months]

   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

2. Maintenance of Implementation fidelity to the protocol [12-24 months]

   Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist, from 12 to 24 months

3. Maintenance of Adoption: percentage of mental health providers who use FLOW intervention [12-24 months]

   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

4. Maintenance of Reach: percentage of specialty mental health patients transitioned to primary care [from 12-24 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas	United States	77030

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Natalie E Hundt, PhD, Michael E. DeBakey VA Medical Center, Houston, TX

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04193033
• Other Study ID Numbers: PEX 19-004
• First Posted: Dec 10, 2019
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by VA Office of Research and Development: mental health

Study Results

No Results Posted as of Jul 18, 2022