Mental HealthFLOWNCT04193033

Evaluation of Implementing FLOW

A study testing FLOW intervention in people with Mental Health, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Mental Health
What is being tested?: FLOW intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 6 Jul 2020to 30 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Non-VA sites and CBOCs smaller than large

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Specific aims for this proposal are:

To evaluate the impact of FLOW, using the evaluation framework RE-AIM, including:
Reach of the program: % of clinic patients transitioned to PC using FLOW
Effectiveness: successful transition to primary care and impact on clinic access for future patients
Adoption: percent of providers in the selected clinics transitioning patients to primary care
Implementation: use of all FLOW components
Maintenance: sustainment of FLOW after withdrawal of external facilitation
To evaluate structural and process implementation factors, including organizational readiness to change, staffing levels, interservice agreements about care, leadership support, and internal facilitation.

Conditions: Mental Health
Being tested: FLOW intervention
Keywords: mental health
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLOW interventionOther
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.

Study groups in NCT04193033
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 12 months
Implementation Fidelity to the Protocol
Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist
Measured: 12 months

Secondary outcomes (3)

Maintenance of Effectiveness of Intervention's Impact on Clinic Access
Encounter slots 'freed up' by FLOW discharges
Measured: 12-18 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
Measured: 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
Measured: from 12-24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202030 Sep 2022

First posted10 Dec 2019
Study start6 Jul 2020
Primary completion1 Sep 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Mental HealthStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
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.
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04193033
Sponsor's protocol ID: PEX 19-004
Acronym: FLOW
Status last verified: Aug 2024
First submitted: 25 Nov 2019
Last updated: 23 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 39326034
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. 2026 Feb;23(1):91-100. doi: 10.1037/ser0000898. Epub 2024 Aug 22.
PubMed 39172402

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Implementing FLOW: Transitioning Stabilized Mental Health Patients to Management in Primary Care (PEC 19-302)
ClinicalTrials.gov ID: NCT04193033
Acronym / sponsor ID: FLOW / PEX 19-004
Conditions: Mental Health
Keywords: mental health
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 6 Jul 2020 (actual)
Primary completion: 1 Sep 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 10 Dec 2019 (actual)
Results: Posted 23 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Specific aims for this proposal are:

To evaluate the impact of FLOW, using the evaluation framework RE-AIM, including:
Reach of the program: % of clinic patients transitioned to PC using FLOW
Effectiveness: successful transition to primary care and impact on clinic access for future patients
Adoption: percent of providers in the selected clinics transitioning patients to primary care
Implementation: use of all FLOW components
Maintenance: sustainment of FLOW after withdrawal of external facilitation
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

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
FLOW intervention	Experimental	Other: FLOW interventionSites 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.
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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

This study uses site-level randomization
Sites must be VA sites with substantial numbers of mental health patients

Key exclusion criteria (1 listed)

Non-VA sites and CBOCs smaller than large

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLOW interventionThe 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

Primary outcome

Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care
Time frame: 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
Effectiveness of Intervention's Impact on Clinic Access
Time frame: Change from baseline to 12 months
Appointments freed up by FLOW consistent discharges from mental health clinics, by site
Adoption: Percent of Mental Health Providers Who Use FLOW Intervention
Time frame: 12 months
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
Implementation Fidelity to the Protocol
Time frame: 12 months
Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist

3 secondary outcomes

Maintenance of Effectiveness of Intervention's Impact on Clinic Access
Time frame: 12-18 months
Maintenance of Implementation Fidelity to the Protocol
Time frame: 12-24 months
Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care
Time frame: from 12-24 months

Results and safety

Results posted to the registry on 23 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLOW Intervention	–	–
Waitlist Until Time 2	–	–
Waitlist Until Time 3	–	–

Primary outcome: Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care

Time frame: Change from baseline to 12 months. Mean (Standard Deviation). Unit: Percent of mental health patients

Measure	FLOW Intervention n = NA	Waitlist Until Time 2 n = NA	Waitlist Until Time 3 n = NA
Value	1.41 (.82)	.77 (.62)	1.89 (1.56)

FLOW Intervention vs Waitlist Until Time 2 vs Waitlist Until Time 3: p = 0.001, Linear Growth Curve Model

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

Primary outcome: Effectiveness of Intervention's Impact on Clinic Access

Time frame: Change from baseline to 12 months. Mean (Standard Deviation). Unit: Appointment slots

Measure	FLOW Intervention n = NA	Waitlist Until Time 2 n = NA	Waitlist Until Time 3 n = NA
Value	148.7 (98.69)	222.33 (337.32)	354.2 (242.49)

FLOW Intervention vs Waitlist Until Time 2 vs Waitlist Until Time 3: p = 0.012, t-test, 2 sided

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

Primary outcome: Adoption: Percent of Mental Health Providers Who Use FLOW Intervention

Time frame: 12 months. Mean (Standard Deviation). Unit: Percent of providers

Measure	FLOW Intervention n = NA	Waitlist Until Time 2 n = NA	Waitlist Until Time 3 n = NA
Value	14.24 (12.98)	8.09 (7.33)	8.47 (4.24)

FLOW Intervention vs Waitlist Until Time 2 vs Waitlist Until Time 3: p = 0.66, ANOVA

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

Primary outcome: Implementation Fidelity to the Protocol

Time frame: 12 months. Mean (Standard Deviation). Unit: Percent of FLOW components

Measure	FLOW Intervention n = NA	Waitlist Until Time 2 n = NA	Waitlist Until Time 3 n = NA
Value	100 (0)	100 (0)	100 (0)

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were not monitored.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events
FLOW Intervention	0 of 0	0 of 0
Waitlist Until Time 2	0 of 0	0 of 0
Waitlist Until Time 3	0 of 0	0 of 0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39326034Hundt 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.
Derived from this study: PubMed 39172402Smith 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. 2026 Feb;23(1):91-100. doi: 10.1037/ser0000898. Epub 2024 Aug 22.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Natalie E Hundt, PhD principal investigator

Michael E. DeBakey VA Medical Center, Houston, TX

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FLOW intervention in people with Mental Health, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care (time frame: Change from baseline to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04193033, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.