Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
To evaluate the impact of FLOW, using the evaluation framework RE-AIM, including:
To evaluate structural and process implementation factors, including organizational readiness to change, staffing levels, interservice agreements about care, leadership support, and internal facilitation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Effectiveness of Intervention's Impact on Clinic Access | Encounter slots 'freed up' by FLOW discharges | 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 |
Not provided
Inclusion Criteria:
This study uses site-level randomization
Sites must be VA sites with substantial numbers of mental health patients
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Natalie E Hundt, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39326034 | Derived | 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. | |
| 39172402 | 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. 2026 Feb;23(1):91-100. doi: 10.1037/ser0000898. Epub 2024 Aug 22. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Waitlist Until Time 2 | Sequence 2: 3 months of usual care, 12 months of FLOW implementation, then 9 months of maintenance |
| FG002 | Waitlist Until Time 3 | Sequence 3: 6 months of usual care, 12 months of FLOW implementation, then 6 months of maintenance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This data was not collected for site level assessments.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Data only collected at site level - not participant level | Posted | Mean | Standard Deviation | Percent of mental health patients | Change from baseline to 12 months | Sites | Sites |
|
Adverse events were not monitored.
Adverse Events were not collected in this site-level randomized trial. This implementation project sought to influence provider behavior; patients were not directly enrolled.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natalie Hundt | Michael E DeBakey VAMC | 713-440-4450 | Natalie.Hundt@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2023 | Aug 15, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided
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.
Not provided
Not provided
Because this is a stepped wedge design QI clinical trial, masking is not feasible.
Not provided
| 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 | from 12-24 months |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | Data only collected at site level, not participant level. | Sites |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| Primary | Effectiveness of Intervention's Impact on Clinic Access | Appointments freed up by FLOW consistent discharges from mental health clinics, by site | Data only collected at site level - not participant level | Posted | Mean | Standard Deviation | Appointment slots | Change from baseline to 12 months | Sites | Sites |
|
|
|
|
| Primary | 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 | Data only collected at site level - not participant level | Posted | Mean | Standard Deviation | Percent of providers | 12 months | Sites | Sites |
|
|
|
|
| Primary | Implementation Fidelity to the Protocol | Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist | Data only collected at site level - not participant level | Posted | Mean | Standard Deviation | Percent of FLOW components | 12 months | Sites | Sites |
|
|
|
| Secondary | Maintenance of Effectiveness of Intervention's Impact on Clinic Access | Encounter slots 'freed up' by FLOW discharges | Data only collected at site level - not participant level | Posted | Mean | Standard Deviation | Appointment slots | 12-18 months | Sites | Sites |
|
|
|
|
| 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 | Data only collected at site level - not participant level | Posted | Mean | Standard Deviation | Percent of FLOW components | 12-24 months | Sites | Sites |
|
|
|
| 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 | Data only collected at site level - not participant level | Posted | Mean | Standard Deviation | Percent of mental health patients | from 12-24 months | Sites | Sites |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided