Evaluation of Implementing FLOW

Mental Health Clinical Trial

— FLOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193033
• Other study ID #: PEX 19-004
• Status: Completed
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health

Intervention

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.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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