Participatory System Dynamics vs Audit and Feedback: A Cluster Randomized Trial of Mechanisms of Implementation Change to Expand Reach of Evidence-based Addiction and Mental Health Care
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Proportion of completed evidence-based practice templates during sessions with a relevant CPT code
研究概览
简要总结
The most common reasons Veterans seek VA addiction and mental health care is for help with opioid and alcohol misuse, depression and PTSD. Research evidence has established highly effective treatments that prevent relapse, overdose and suicide, but even with policy mandates, performance metrics, and electronic health records to fix the problem, these treatments may only reach 3-28% of patients. This study tests participatory business engineering methods (Participatory System Dynamics) that engage patients, providers and policy makers against the status quo approaches, such as data review, and will determine if participatory system dynamics works, why it works, and whether it can be applied in many health care settings to guarantee patient access to the highest quality care and better meet the addiction and mental health needs of Veterans and the U.S. population.
详细描述
The broad aim is to empower all healthcare stakeholders to provide the highest quality care to all patients. The specific aims address the complexities and tradeoffs associated with implementing evidence-based practices (EBPs) in outpatient addiction and mental health systems. There is scientific consensus about the best evidence-based psychotherapies and pharmacotherapies (EBPs) to meet the needs of patients with opioid and alcohol use disorder, PTSD and depression. However, EBP coordination over time, within and across multidisciplinary teams of providers, is complex and constantly changing. Veterans Health Administration (VA) policy mandates, national training programs, and incentivized quality measures, have been insufficient for reaching more than 3 to 28% of patients with the highest quality treatments. In fact, limited EBP reach is common in health systems and the field of implementation science seeks to address it. One routine strategy is data auditing with provider feedback (audit-and-feedback; AF), however, the impact is highly variable. As an alternative, participatory system dynamics (PSD) has been used to explain causes of complex problems in business management for 60 years. Partnering with frontline staff using PSD to determine how EBP reach emerges from local resources and constraints, and is determined by system dynamics, such as delays and feedback. The dynamics of EBP reach were formally specified in differential equation models, and tested against VA data drawn from a national VA SQL database. Using existing enterprise data to tailor model parameters to each care team. PSD models were made accessible via a 'Modeling to Learn' interface and training, during which teams safely evaluated local change scenarios via simulation to find the highest yield options for meeting Veterans' needs. PSD learning simulations produce immediate, real-time feedback to the teams who coordinate care, improving day-to-day decisions and long-term improvement plans. The study design is a two-arm, 24-site (12 sites/arm) cluster randomized trial to test the effectiveness of PSD simulation as compared to more standard team AF data review. The hypothesis is that PSD will be superior to AF for improving EBP initiation and dose (Aim 1). The investigators will test the PSD theory of change that the effect of PSD on improved EBP reach is explained by improvement in team systems thinking (Aim 2). To confirm the potential for widespread usefulness of PSD, by also testing the generalizability of PSD causal dynamics across PSD and AF arms (Aim 3). This study has the potential to inform a new paradigm, by determining what works to improve health system quality defined as EBP reach, why it works, and under what conditions. If PSD is effective, study activities will address a national priority to improve Veterans' addiction and mental health care to prevent chronic symptoms, relapse, suicide and overdose. Findings from the proposed tests of effectiveness, causality, and generality, could also catalyze future applications to make a significant public health impact across the continuum of healthcare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VA divisions and community-based outpatient clinics (CBOCs) or 'clinics' from regional VA health systems
- •Must be below the overall VA quality median (as assessed by the Strategic Analytics for Improvement and Learning or SAIL), which includes 3 of 8 SAIL measures associated with four evidence-based psychotherapies and three evidence-based pharmacotherapies for depression, PTSD, and opioid use disorder.
排除标准
- •clinics with less than 12 months of data in 2018
- •clinics already involved in Office of Veterans Access to Care (OVACS) quality improvement program at baseline.
- •clinics where the VA Cerner electronic health record (EHR) implementation rollout will occur during the project period (Veterans Integrated Services Networks (VISNs) 20, 21 ,22, and 7)
- •clinics who serve less than 122 unique patients each month on average
- •clinics without an onsite multidisciplinary team of mental health or addiction service providers (minimum required: 1 psychiatrist, 1 psychologist, 1 social worker onsite)
研究组 & 干预措施
Participatory System Dynamics (PSD)
12 clinics assigned to PSD
干预措施: Participatory System Dynamics (PSD) (Other)
Audit and Feedback (AF)
12 clinics assigned to AF
干预措施: Audit and Feedback (AF) (Other)
结局指标
主要结局
Proportion of completed evidence-based practice templates during sessions with a relevant CPT code
时间窗: Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
We will study 5 evidence-based psychotherapies: 3 for depression (Cognitive Behavior Therapy (CBT-D), Acceptance and Commitment Therapy (ACT), and Interpersonal Psychotherapy (IPT)) and 2 for PTSD (Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT)). Data is gathered based on electronic health record data from the Corporate Data Warehouse (CDW).
Proportion of patients diagnosed with alcohol use disorder, depression, opioid use disorder, or PTSD who meet evidence-based psychotherapy and pharmacotherapy initiation and course measures divided by total number of patients with these diagnoses
时间窗: Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
Initiation of an evidence-based practice is indicated by an evidence-based psychotherapy template or evidence-based pharmacotherapy prescription after intake. Adequate course is based on receiving an adequate number of evidence-based psychotherapy sessions to be a "completer" (typically 8 sessions) or enough refills for a guideline-recommended adequate trial of each medication (varies by medication). Data is gathered based on electronic health record data from the VA Corporate Data Warehouse (CDW).
Proportion of combination of prescriptions placed with the VA pharmacy and sessions with a relevant CPT code
时间窗: Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
We will study 8 evidence-based pharmacotherapies: 2 for depression (84 and 180 days therapeutic continuity at new antidepressant start), 2 for Opioid Use Disorder (OUD) (methadone and buprenorphine), and 4 for Alcohol Use Disorder (AUD) (Acamprosate, Disulfiram, Naltrexone, and Topiramate). Data is gathered based on electronic health record data from the Corporate Data Warehouse (CDW).
次要结局
- Patient Aligned Care team Burnout Measure (PACT) [followed by its scale information in the Description](At baseline and 6 months)
- Degree of acceptability of intervention assessed by the Acceptability of Intervention Measure (AIM) [followed by its scale information in the Description](At 6 months)
- Degree of appropriateness of intervention assessed by the Intervention Appropriateness Measure (IAM) [followed by its scale information in the Description](At 6 months)
- Degree of feasibility of intervention assessed by the Feasibility of Intervention Measure (FIM) [followed by its scale information in the Description](At 6 months)
- Team Decision Making Questionnaire (TDMQ) [followed by its scale information in the Description](At 6 months)
- Systems Thinking Scale (STS) [followed by its scale information in the Description](At baseline and 6 months)
- Learning Organization Survey (LOS-27) [followed by its scale information in the Description](At baseline and 6 months)
- Systems Thinking Codebook and Session Observations [followed by its scale information in the Description](Over 6 months)
- Facilitator Fidelity to Intervention Guides and Theory of Change(Over 6 months)
- Demographic Measures(At baseline and 6 months)
研究者
Lindsey Zimmerman
Principal Investigator
Palo Alto Veterans Institute for Research
