Evaluation of Implementing FLOW: Transitioning Stabilized Mental Health Patients to Management in Primary Care (PEC 19-302)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Adoption: Percent of Mental Health Providers Who Use FLOW Intervention
研究概览
简要总结
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.
详细描述
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:
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To evaluate the impact of FLOW, using the evaluation framework RE-AIM, including:
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Reach of the program: % of clinic patients transitioned to PC using FLOW
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Effectiveness: successful transition to primary care and impact on clinic access for future patients
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Adoption: percent of providers in the selected clinics transitioning patients to primary care
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Implementation: use of all FLOW components
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Maintenance: sustainment of FLOW after withdrawal of external facilitation
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To evaluate structural and process implementation factors, including organizational readiness to change, staffing levels, interservice agreements about care, leadership support, and internal facilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Because this is a stepped wedge design QI clinical trial, masking is not feasible.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-VA sites and CBOCs smaller than large
研究组 & 干预措施
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.
干预措施: FLOW intervention (Other)
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.
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.
结局指标
主要结局
Adoption: Percent of Mental Health Providers Who Use FLOW Intervention
时间窗: 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
Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care
时间窗: 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
时间窗: Change from baseline to 12 months
Appointments freed up by FLOW consistent discharges from mental health clinics, by site
Implementation Fidelity to the Protocol
时间窗: 12 months
Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist
次要结局
- Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care(from 12-24 months)
- Maintenance of Effectiveness of Intervention's Impact on Clinic Access(12-18 months)
- Maintenance of Implementation Fidelity to the Protocol(12-24 months)