Singh Jasvinder A, Hearld Larry R, Hall Allyson G, Beasley T Mark
Medicine Service, VA Medical Center, 700 19th St S, AL, Birmingham, 35233, USA.
Department of Medicine at School of Medicine, University of Alabama at Birmingham, 1720 Second Ave South, Birmingham, AL, 35294-0022, USA.
Implement Sci Commun. 2021 Mar 11;2(1):30. doi: 10.1186/s43058-021-00118-9.
To provide the details of the study protocol for an observational, case study design, implementation trial.
Implementing the DEcision-Aid for Lupus (IDEAL) study will put into practice a shared decision-making (SDM) strategy, using an individualized, culturally appropriate computerized decision-aid (DA) for lupus patients in 15 geographically diverse clinics in the USA. The overarching frameworks that guide this implementation study are the Consolidated Framework for Implementation Research (CFIR) and Powell's typology of implementation strategies. All 15 clinics will receive standardized capacity-building activities for lupus DA implementation in the clinic, including education, training, technical assistance, re-training, and incorporation of a clinic champion in the core team of each site. In addition, clinics will also choose among clinic-targeted activities to integrate the DA into existing work processes and/or patient-targeted activities to raise awareness and educate patients about the DA. These activities will be chosen to stimulate participant recruitment and retention activities that support the implementation of the DA at their clinic. In study aim 1, using surveys and semi-structured interviews with clinic personnel in 15 lupus clinics, we will assess stakeholder needs and identify clinic and contextual characteristics that inform the implementation strategy component selection and influence implementation effectiveness. Study aim 2 is to implement and assess the effectiveness of the IDEAL (standardized and tailored) strategy in 15 lupus clinics by examining the changes in our primary outcome of penetration, i.e., the proportion of all eligible patients in the clinic that receive the lupus DA, and secondary outcomes include DA appropriateness, acceptability, success, permanence, and feasibility. Study aim 3 is to identify ways to sustain and disseminate our lupus DA via semi-structured debriefing interviews with key clinic personnel and patients.
The study will enroll at least 500 patient participants with lupus across all 15 sites and assess the effectiveness in implementing the DA in various clinic settings across the USA.
ClinicalTrials.gov, NCT03735238 . Protocol version number: 15, date 6/8/2020.
为一项观察性病例研究设计的实施试验提供研究方案的详细信息。
实施狼疮决策辅助工具（IDEAL）研究将把一种共享决策（SDM）策略付诸实践，在美国15个地理位置各异的诊所中，为狼疮患者使用个性化的、符合文化背景的计算机化决策辅助工具（DA）。指导这项实施研究的总体框架是实施研究综合框架（CFIR）和鲍威尔的实施策略类型学。所有15个诊所都将接受针对狼疮DA在诊所实施的标准化能力建设活动，包括教育、培训、技术援助、再培训，并在每个站点的核心团队中纳入一名诊所倡导者。此外，诊所还将在针对诊所的活动中进行选择，以将DA整合到现有工作流程中，和/或选择针对患者的活动，以提高对DA的认识并对患者进行相关教育。选择这些活动是为了促进参与者招募和留存活动，以支持在其诊所实施DA。在研究目标1中，通过对15个狼疮诊所的诊所工作人员进行调查和半结构化访谈，我们将评估利益相关者的需求，并确定影响实施策略组成部分选择和实施效果的诊所及背景特征。研究目标2是通过检查我们的主要结局指标渗透率（即诊所中所有符合条件的患者接受狼疮DA的比例）的变化，在15个狼疮诊所实施并评估IDEAL（标准化和量身定制）策略的有效性，次要结局指标包括DA的适宜性、可接受性、成功率、持久性和可行性。研究目标3是通过与关键诊所工作人员和患者进行半结构化汇报访谈，确定维持和推广我们的狼疮DA的方法。
该研究将在所有15个站点招募至少500名狼疮患者参与者，并评估在美国各地不同诊所环境中实施DA的有效性。
ClinicalTrials.gov，NCT03735238。方案版本号：15，日期2020年8月6日。
