Trial Outcomes & Findings for Evaluation of Implementing FLOW (NCT NCT04193033)

NCT ID: NCT04193033

Last Updated: 2024-08-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Change from baseline to 12 months
• Results posted on: 2024-08-23

Participant Flow

Unit of analysis: sites

Participant milestones

Measure	FLOW Intervention Sequence 1: 12 months of FLOW implementation, then 12 months of maintenance. Sites received 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. Because this is a site-level trial, participants and providers were not directly enrolled in the trial. 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.	Waitlist Until Time 2 Sequence 2: 3 months of usual care, 12 months of FLOW implementation, then 9 months of maintenance	Waitlist Until Time 3 Sequence 3: 6 months of usual care, 12 months of FLOW implementation, then 6 months of maintenance
Overall Study STARTED	0 3	0 3	0 3
Overall Study COMPLETED	0 3	0 3	0 3
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data only collected at site level, not participant level.

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Change from baseline to 12 months

Population: Data only collected at site level - not participant level

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

Outcome measures

Measure	FLOW Intervention n=3 Sites 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. 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.	Waitlist Until Time 2 n=3 Sites 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 n=3 Sites 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.
Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care	1.41 Percent of mental health patients Standard Deviation .82	.77 Percent of mental health patients Standard Deviation .62	1.89 Percent of mental health patients Standard Deviation 1.56

PRIMARY outcome

Timeframe: Change from baseline to 12 months

Population: Data only collected at site level - not participant level

Appointments freed up by FLOW consistent discharges from mental health clinics, by site

Outcome measures

Measure	FLOW Intervention n=3 Sites 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. 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.	Waitlist Until Time 2 n=3 Sites 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 n=3 Sites 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.
Effectiveness of Intervention's Impact on Clinic Access	148.7 Appointment slots Standard Deviation 98.69	222.33 Appointment slots Standard Deviation 337.32	354.2 Appointment slots Standard Deviation 242.49

PRIMARY outcome

Timeframe: 12 months

Population: Data only collected at site level - not participant level

Percent of mental health providers who use the FLOW intervention for at least 3 patients, compared to the total number of mental health providers in the participating clinics

Outcome measures

Measure	FLOW Intervention n=3 Sites 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. 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.	Waitlist Until Time 2 n=3 Sites 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 n=3 Sites 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.
Adoption: Percent of Mental Health Providers Who Use FLOW Intervention	14.24 Percent of providers Standard Deviation 12.98	8.09 Percent of providers Standard Deviation 7.33	8.47 Percent of providers Standard Deviation 4.24

PRIMARY outcome

Timeframe: 12 months

Population: Data only collected at site level - not participant level

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

Outcome measures

Measure	FLOW Intervention n=3 Sites 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. 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.	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.	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.
Implementation Fidelity to the Protocol	100 Percent of FLOW components Standard Deviation 0	100 Percent of FLOW components Standard Deviation 0	100 Percent of FLOW components Standard Deviation 0

SECONDARY outcome

Timeframe: 12-18 months

Population: Data only collected at site level - not participant level

Encounter slots 'freed up' by FLOW discharges

Outcome measures

Measure	FLOW Intervention n=3 Sites 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. 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.	Waitlist Until Time 2 n=3 Sites 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 n=3 Sites 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.
Maintenance of Effectiveness of Intervention's Impact on Clinic Access	171.73 Appointment slots Standard Deviation 50.67	81.26 Appointment slots Standard Deviation 95.76	147 Appointment slots Standard Deviation 140.36

SECONDARY outcome

Timeframe: 12-24 months

Population: Data only collected at site level - not participant level

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

Outcome measures

Measure	FLOW Intervention n=3 Sites 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. 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.	Waitlist Until Time 2 n=3 Sites 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 n=3 Sites 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.
Maintenance of Implementation Fidelity to the Protocol	100 Percent of FLOW components Standard Deviation 0	100 Percent of FLOW components Standard Deviation 0	100 Percent of FLOW components Standard Deviation 0

SECONDARY outcome

Timeframe: from 12-24 months

Population: Data only collected at site level - not participant level

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

Outcome measures

Measure	FLOW Intervention n=3 Sites 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. 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.	Waitlist Until Time 2 n=3 Sites 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 n=3 Sites 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.
Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care	2.95 Percent of mental health patients Standard Deviation 2.13	1.08 Percent of mental health patients Standard Deviation 1.25	2.59 Percent of mental health patients Standard Deviation 2.13

Adverse Events

FLOW Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Until Time 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Until Time 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Natalie Hundt

Michael E DeBakey VAMC

Phone: 713-440-4450

Email: Natalie.Hundt@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place