Evaluation of Implementing FLOW

NCT04193033 | Completed Results

• 1 other identifier: PEX 19-004
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health

Keywords

mental health

Outcome Measures

Primary Outcomes (4)

• 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

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

  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 3 patients, compared to the total number of mental health providers in the participating clinics

  12 months

• Implementation Fidelity to the Protocol

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

  12 months

Secondary Outcomes (3)

• Maintenance of Effectiveness of Intervention's Impact on Clinic Access

  12-18 months

• Maintenance of Implementation Fidelity to the Protocol

  12-24 months

• Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care

  from 12-24 months

Study Arms (3)

FLOW intervention

EXPERIMENTAL

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

Waitlist until Time 2

NO INTERVENTION

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

NO INTERVENTION

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.

Interventions

FLOW intervention OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-VA sites and CBOCs smaller than large

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Hundt NE, Kim B, Plasencia M, Amspoker AB, Walder A, Yusuf Z, Nagamoto H, Tsao CG, Smith TL. Factors associated with successful FLOW implementation to improve mental health access: a mixed-methods study. Transl Behav Med. 2024 Nov 25;14(12):693-702. doi: 10.1093/tbm/ibae050.

  PMID: 39326034 DERIVED

• Smith TL, Yusuf ZI, Kim B, Amspoker AB, Hundt NE. An external facilitation case study analysis of an implementation trial of FLOW: A program for improving the transition of patients with mental health disorders back to primary care. Psychol Serv. 2024 Aug 22. doi: 10.1037/ser0000898. Online ahead of print.

  PMID: 39172402 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Limitations and Caveats

Because this was a cluster randomized stepped wedge trial in which 9 sites were randomized to receive the intervention at different times, we have no comparison sites which never received the intervention and the overall sample size (n = 9) was small. Additionally, the 9 sites were all in one VA Veterans Integrated Service Network (VISN), under the same VISN leadership, so some informal spread of information about the intervention via informal networks may have occurred.

Results Point of Contact

• Title: Dr. Natalie Hundt
• Organization: Michael E DeBakey VAMC

Natalie.Hundt@va.gov

713-440-4450

Study Officials

• Natalie E Hundt, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because this is a stepped wedge design QI clinical trial, masking is not feasible.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 10, 2019
• Study Start: July 6, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)