Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.
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DOI:
10.1186/s13012-014-0132-x
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发表时间:
2014-09-30
期刊:
Implementation science : IS
影响因子:
--
通讯作者:
Thomas MR
Thomas MR
中科院分区:
其他
文献类型:
--
作者:
Kilbourne AM;Almirall D;Eisenberg D;Waxmonsky J;Goodrich DE;Fortney JC;Kirchner JE;Solberg LI;Main D;Bauer MS;Kyle J;Murphy SA;Nord KM;Thomas MR

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尽管有心理社会循证实践(EBP),但精神障碍患者的治疗和结果仍然不理想。复制有效计划 (REP) 是一种有效的实施策略,但仍然只有不到一半的站点使用了 EBP。该整群随机试验的主要目的是确定在最初对 REP 没有反应的站点中,以外部促进者 (EF) 或外部促进者加内部促进者 (IF) 开始的适应性实施策略对改善 EBP 使用和 12 个月内患者预后的影响。本研究采用序贯多重分配随机试验 (SMART) 设计来构建自适应实施策略。即将实施的 EBP 是针对来自美国不同地区的 80 个社区门诊诊所(N N = 1,600 名患者)的情绪障碍患者的生活目标 (LG)。最初对 REP 没有反应的站点(定义为接受 ≥3 次 EBP 疗程的<50% 患者)将被随机分配接受来自 EF 或 EF/IF 的额外支持。此外,随机接受 EF 且仍无反应的部位将随机继续单独使用 EF 或接受 EF/IF。 EF 提供在日常实践中调整 LG 的技术专业知识,而现场 IF 与现场领导层有直接报告关系,以支持 LG 在日常实践中的使用。主要结局是与心理健康相关的生活质量;次要结果包括接受 LG 会议、情绪症状、实施成本和组织变革。该研究设计将确定单独使用场外 EF 与添加现场 IF 是否可以改善最初对 REP 没有反应的站点中的 EBP 摄取和患者预后。它还将研究延迟提供 EF/IF 对于尽管 EF 仍然没有响应的站点的价值。 ClinicalTrials.gov 标识符:NCT02151331 本文的在线版本 (doi:10.1186/s13012-014-0132-x) 包含补充材料,可供授权用户使用。
Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months. This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as <50% patients receiving ≥3 EBP sessions) will be randomized to receive additional support from an EF or both EF/IF. Additionally, sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF. The EF provides technical expertise in adapting LG in routine practice, whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice. The primary outcome is mental health-related quality of life; secondary outcomes include receipt of LG sessions, mood symptoms, implementation costs, and organizational change. This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF. ClinicalTrials.gov identifier: NCT02151331 The online version of this article (doi:10.1186/s13012-014-0132-x) contains supplementary material, which is available to authorized users.
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发表时间: 2009-08-07
期刊: Implementation science : IS
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期刊: HEALTH AFFAIRS
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影响因子: 2.6
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影响因子: 3.8
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