In partnership with a state Medicaid home and community-based waiver program, this study tests implementation strategies for adoption and sustainability of an evidence-based intervention to support disabled and older adults who have difficulty with physical function and daily living tasks. A multi-level implementation strategy bundle will be directed at relationship, coalition, and team building; readiness to implement, leadership, and clinician attitude toward evidence assessments; intervention and facilitation training; interdisciplinary coordination; facilitation; and audit and feedback to support practice change. Knowledge-to-Action model underpins this 2-arm, 3-year pragmatic mixed method randomized hybrid type III trial in 18 waiver program sites in Michigan. Data will be collected on sites, 775 clinicians (registered nurses, occupational therapists, social workers), and 15,000 disabled and older adults. Consolidated Framework for Implementation Research guides examination of site, clinician, and beneficiary characteristics; clinician attitude and self-efficacy; leadership and readiness to implement; and intervention impact on beneficiary outcomes. Sites will be randomized to either usual waiver care with internal facilitation of the bundle of implementation strategies or usual waiver care with both internal and external facilitation of the bundle. Primary outcomes are site-level adoption and sustainability over 12 months, and intervention effects on these outcomes are hypothesized to be mediated by clinicians’ attitude and self-efficacy. At the beneficiary level, by addressing the individual’s capabilities and home environment, the intervention is hypothesized to improve secondary outcomes of activities of daily living, pain, depression, falls, emergency department visits, and hospitalizations. Baseline site readiness and leadership and stages of implementation at 6 months will be explored as potential moderators. Linear mixed effects models will be used to test intervention effects on primary outcomes, with bias-correcting analytic strategy in mediation analyses. Generalized linear mixed effects modeling will be employed for the analysis of intervention effects on secondary outcomes. Synthesizing findings within and across the sites, we will specify how leadership, readiness for change, and level of facilitation enhance capacity for adoption and sustainability of an evidence-based intervention in an under-resourced Medicaid setting that cares for disabled and older adults. ClinitalTrials.gov , NCT03634033 . Registered 16 August 2018.

中文翻译：

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在医疗补助豁免中测试关于证据采用和可持续性的实施策略捆绑，以优化社区居民的残疾人和老年人的身体机能：多地点，务实的混合III型协议

与一项国家医疗补助计划的基于家庭和社区的豁免计划合作，该研究测试了采用和可持续实施循证干预措施的实施策略，以支持身体功能和日常生活有困难的残疾人和老年人。多层次的实施策略包将针对关系，联盟和团队建设；准备实施，领导力和临床医生对证据评估的态度；干预和促进培训；跨学科协调；便利化 以及审核和反馈以支持实践变更。知识到行动模型在密歇根州的18个豁免计划站点中进行了这项2臂，3年，务实的混合方法III型随机混合试验的基础。将在以下地点收集数据：775名临床医生（注册护士，职业治疗师，社会工作者）和15,000名残疾人和老年人。实施研究综合框架指导现场，临床医生和受益人特征的检查；临床医生的态度和自我效能感；领导能力和实施意愿；干预对受益人结局的影响。站点将被随机分配到内部，以简化实施策略捆绑的通常弃权护理，或内部和外部简化为实施捆绑的通常弃权护理。主要结果是在站点级别采用和在12个月内具有可持续性，并且假设对这些结果的干预效果是由临床医生的态度和自我效能感所介导的。在受益人一级，通过解决个人的能力和家庭环境，假设干预措施可以改善日常生活，疼痛，抑郁，跌倒，急诊就诊和住院等活动的次要结果。作为潜在的主持人，将探讨基准站点的准备情况和领导力以及在六个月时的实施阶段。线性混合效应模型将用于测试干预对主要结果的影响，并在调解分析中采用偏倚校正分析策略。广义线性混合效应模型将用于分析对次要结果的干预效应。综合站点内部和站点之间的发现，我们将说明领导力，变革准备，便利的程度提高了在资源匮乏的医疗救助机构中采用基于证据的干预措施的能力和可持续性，该机构照顾残疾人和老年人。ClinitalTrials.gov，NCT03634033。2018年8月16日注册。