跳至主要内容
临床试验/NCT04208217
NCT04208217已完成不适用

Participatory System Dynamics vs Usual Quality Improvement: Is Staff Use of Simulation an Effective, Scalable and Affordable Way to Improve Timely Veteran Access to High-quality Mental Health Care?

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2021年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
720
试验地点
1
主要终点
Number of completed EBPsy templates during sessions with a relevant CPT code

研究概览

简要总结

Evidence-based VA care is best for meeting Veterans' mental health needs, such as depression, PTSD and opioid use disorder, to prevent suicide or overdose. But some key evidence-based practices only reach 3-28% of patients. Participatory system dynamics (PSD) helps improve quality with existing resources, critical in mental health and all VA health care. PSD uses learning simulations to improve staff decisions, showing how goals for quality can best be achieved given local resources and constraints. This study aims to significantly increase the proportion of patients who start and complete evidence-based care, and determine the costs of using PSD for improvement. Empowering frontline staff with PSD simulation encourages safe 'virtual' prototyping of complex changes to scheduling, referrals and staffing, before translating changes to the 'real world.' This study determines if PSD increases Veteran access to the highest quality care, and if PSD better maximizes VA resources when compared against usual trial-and-error approaches to improving quality.

详细描述

Background: Evidence-based practices (EBPs) are the most high value treatments to meet Veterans' addiction and mental health needs, reduce chronic impairment, and prevent suicide or overdose. Over 10 years, VA invested in dissemination of evidence-based psychotherapies and pharmacotherapies based on substantial evidence of effectiveness as compared to usual care. Quality metrics also track progress. Despite these investments, patients with prevalent needs, such as depression, PTSD and opioid use disorder often don't receive EBPs. Systems theory explains limited EBP reach as a system behavior emerging dynamically from local components (e.g., patient demand/health service supply). Participatory research and engagement principles guide participatory system dynamics (PSD), a mixed-methods approach used in business and engineering, shown to be effective for improving quality with existing resources.

Significance/Impact: This study is proposed in the high priority area of VA addiction and mental health care to improve Veteran access to VA's highest quality care. The PSD program, Modeling to Learn (MTL), improves frontline management of dynamic complexity through simulations of staffing, scheduling and service referrals common in healthcare, across generalist and specialty programs, patient populations, and provider disciplines/treatments.

Innovation: Recent synthesis of VA data in the enterprise-wide SQL Corporate Data Warehouse (CDW) makes it feasible to scale participatory simulation learning activities with VA frontline addiction and mental health staff. MTL is an advanced quality improvement (QI) infrastructure that helps VA take a major step toward becoming a learning health care system, by empowering local multidisciplinary staff to develop change strategies that fit to local capacities and constraints. Model parameters are from one VA source and generic across health services. If findings show that MTL is superior to usual VA quality improvement activities of data review with facilitators from VA program offices, this paradigm could prove useful across VA services. The PSD approach also advances implementation science. Systems theory explains how dynamic system behaviors (EBP reach) are defined by general scientific laws, yet arise from idiographic local conditions. Empowering staff with systems science simulation encourages the safe prototyping of ideas necessary for learning, increasing ongoing quality improvement capacities, and saving time and money as compared to trial-and-error approaches.

Specific Aims:

  1. Effectiveness: Test for superiority of MTL over usual QI for increasing the proportion of patients (1a) initiating, and (1b) completing a course of evidence-based psychotherapy (EBPsy) and evidence-based pharmacotherapy (EBPharm).
  2. Scalable: (2a) Evaluate usual QI and MTL fidelity. (2b) Test MTL fidelity for convergent validity with participatory measures. (2c) Test the participatory theory of change: Evaluate whether 12 month period EBP reach is mediated by team scores on participatory measures.
  3. Affordable: (3a) Determine the budget impact of MTL. (3b). Calculate the average marginal costs per 1% increase in EBP reach.

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

入选标准

  • 24 health care systems currently functioning below the median VA mental health recommendations for Strategic Analytics for Improvement & Learning (SAIL) and below the median for 3 of 8 SAIL evidence-based treatment approaches.
  • 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

  • Health care systems functioning above median VA mental health recommendations for Strategic Analytics for Improvement & Learning (SAIL) and below the median for 3 of 8 SAIL evidence-based treatment approaches. Only one health care system can be included per arm - MTL vs QI.
  • clinics with less than 12 months of data in 2018
  • clinics 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

Modeling to Learn (MTL)

Experimental

12 clinics randomly assigned to MTL

干预措施: Modeling to Learn (MTL) (Behavioral)

Usual quality improvement (QI)

Experimental

12 clinics randomly assigned to usual QI

干预措施: Usual quality improvement (QI) (Behavioral)

结局指标

主要结局

Number of completed EBPsy templates during sessions with a relevant CPT code

时间窗: Pre-/Post- 12-month period average of EBP reach (24 months total observation)]

Proportion of 3 EBPsy treatments for depression - Cognitive Behavior Therapy (CBT-D), Acceptance and Commitment Therapy (ACT), Interpersonal Psychotherapy (IPT) 2 EBPsy for PTSD - Prolonged Exposure (PE), and Cognitive Processing Therapy (CPT)

Proportion of patients initiating and completing a course of evidence-based psychotherapy (EBPsy) or evidence-based pharmacotherapy (EBPharm)

时间窗: Pre-/Post- 12-month period average of EBP reach (24 months total observation)]

Proportion evidence-based practice (EBP) reach is defined as the proportion of VA outpatient addiction and mental health patients who receive evidence-based psychotherapy and/or evidence-based pharmacotherapy for opioid use disorder, depression, or PTSD in routine outpatient VA care.

Number 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 EBP reach (24 months total observation)]

Proportion of 2 EBPharm treatments for depression - 84 and 180 days therapeutic continuity at new antidepressant start and 2 EBPharm for Opioid Use Disorder (OUD) - methadone and buprenorphine

次要结局

  • Differences in team perceptions of MTL and QI assessed by the Acceptability of Intervention Measure (AIM)(at 6 months)
  • Participatory Measure: Relationships(At 6 months)
  • QI Fidelity Checklist for 12-Session Plan(Throughout 6 months)
  • Differences in team perceptions of MTL and QI assessed by the Feasibility of Intervention Measure (FIM)(at 6 months)
  • Differences in team perceptions of MTL and QI assessed by the Intervention Appropriateness Measure (IAM)(at 6 months)
  • Participatory Measure: Context(At baseline and 6 months)
  • Participatory Measure: Partnership Structural Values(At 6 months)
  • Demographic Measures(At baseline and 6 months)
  • Participatory Measure: Synergy(At 6 months)
  • Participatory Measure: Capacity-Building Index(At 6 months)
  • MTL Fidelity Checklist for 12-Session Plan(Throughout 6 months)
  • Quality Improvement Activity Tracking(Throughout 6 months)
  • Patient Aligned Care Team Burnout Measure (PACT)(At baseline and 6 months)
  • Facilitator Quality: Engagement Principles(At 6 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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