Mental Health
Conditions
Keywords
mental health
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.
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. 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.
Interventions
OTHERFLOW 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Because this is a stepped wedge design QI clinical trial, masking is not feasible.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care | 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 | 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 | 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 | 12 months | Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Implementation Fidelity to the Protocol | 12-24 months | Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist, from 12 to 24 months |
| Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care | from 12-24 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, during the maintenance period |
| Maintenance of Effectiveness of Intervention's Impact on Clinic Access | 12-18 months | Encounter slots 'freed up' by FLOW discharges |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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 |
| 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 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — Sites |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 12 months
Population: Data only collected at site level - not participant level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLOW Intervention | Adoption: Percent of Mental Health Providers Who Use FLOW Intervention | 14.24 Percent of providers | Standard Deviation 12.98 |
| Waitlist Until Time 2 | Adoption: Percent of Mental Health Providers Who Use FLOW Intervention | 8.09 Percent of providers | Standard Deviation 7.33 |
| Waitlist Until Time 3 | Adoption: Percent of Mental Health Providers Who Use FLOW Intervention | 8.47 Percent of providers | Standard Deviation 4.24 |
p-value: 0.66ANOVA
Primary
Effectiveness of Intervention's Impact on Clinic Access
Appointments freed up by FLOW consistent discharges from mental health clinics, by site
Time frame: Change from baseline to 12 months
Population: Data only collected at site level - not participant level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLOW Intervention | Effectiveness of Intervention's Impact on Clinic Access | 148.7 Appointment slots | Standard Deviation 98.69 |
| Waitlist Until Time 2 | Effectiveness of Intervention's Impact on Clinic Access | 222.33 Appointment slots | Standard Deviation 337.32 |
| Waitlist Until Time 3 | Effectiveness of Intervention's Impact on Clinic Access | 354.2 Appointment slots | Standard Deviation 242.49 |
p-value: 0.012t-test, 2 sided
Primary
Implementation Fidelity to the Protocol
Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist
Time frame: 12 months
Population: Data only collected at site level - not participant level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLOW Intervention | Implementation Fidelity to the Protocol | 100 Percent of FLOW components | Standard Deviation 0 |
| Waitlist Until Time 2 | Implementation Fidelity to the Protocol | 100 Percent of FLOW components | Standard Deviation 0 |
| Waitlist Until Time 3 | Implementation Fidelity to the Protocol | 100 Percent of FLOW components | Standard Deviation 0 |
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
Time frame: Change from baseline to 12 months
Population: Data only collected at site level - not participant level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLOW Intervention | Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care | 1.41 Percent of mental health patients | Standard Deviation 0.82 |
| Waitlist Until Time 2 | Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care | .77 Percent of mental health patients | Standard Deviation 0.62 |
| Waitlist Until Time 3 | Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care | 1.89 Percent of mental health patients | Standard Deviation 1.56 |
p-value: 0.001Linear Growth Curve Model
Secondary
Maintenance of Effectiveness of Intervention's Impact on Clinic Access
Encounter slots 'freed up' by FLOW discharges
Time frame: 12-18 months
Population: Data only collected at site level - not participant level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLOW Intervention | Maintenance of Effectiveness of Intervention's Impact on Clinic Access | 171.73 Appointment slots | Standard Deviation 50.67 |
| Waitlist Until Time 2 | Maintenance of Effectiveness of Intervention's Impact on Clinic Access | 81.26 Appointment slots | Standard Deviation 95.76 |
| Waitlist Until Time 3 | Maintenance of Effectiveness of Intervention's Impact on Clinic Access | 147 Appointment slots | Standard Deviation 140.36 |
p-value: 0.49Linear Growth Curve Model
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
Time frame: 12-24 months
Population: Data only collected at site level - not participant level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLOW Intervention | Maintenance of Implementation Fidelity to the Protocol | 100 Percent of FLOW components | Standard Deviation 0 |
| Waitlist Until Time 2 | Maintenance of Implementation Fidelity to the Protocol | 100 Percent of FLOW components | Standard Deviation 0 |
| Waitlist Until Time 3 | Maintenance of Implementation Fidelity to the Protocol | 100 Percent of FLOW components | Standard Deviation 0 |
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
Time frame: from 12-24 months
Population: Data only collected at site level - not participant level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLOW Intervention | Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care | 2.95 Percent of mental health patients | Standard Deviation 2.13 |
| Waitlist Until Time 2 | Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care | 1.08 Percent of mental health patients | Standard Deviation 1.25 |
| Waitlist Until Time 3 | Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care | 2.59 Percent of mental health patients | Standard Deviation 2.13 |
p-value: 0.06t-test, 2 sided