Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-07 @ 12:38 PM
Study NCT ID:
NCT04193033
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Implementing FLOW
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Evaluation of Implementing FLOW: Transitioning Stabilized Mental Health Patients to Management in Primary Care (PEC 19-302)
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLOW
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: