Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
II. Department of Medicine, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Implement Sci. 2018 Mar 27;13(1):51. doi: 10.1186/s13012-018-0740-y.
Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care.
We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary.
This study is the first large study on routine implementation of SDM conducted in German cancer care. We expect to foster implementation of SDM at the enrolled clinics. Insights gained from this study, using a theoretically and empirically grounded approach, can inform other SDM implementation studies and health policy developments, both nationally and internationally.
clinicaltrials.gov, NCT03393351 . Registered 8 January 2018.
共享决策（SDM）在医疗保健中变得越来越重要。然而，尽管有科学证据、有效的实施策略以及在卫生政策议程上的突出地位，SDM 迄今为止尚未在常规实践中广泛实施。因此，我们在一项试点研究中，通过对当前状态和需求评估进行分析，基于整合实施研究框架（CFIR），制定了一个在肿瘤学中实施 SDM 的常规程序。基于这些结果，我们当前研究的主要目的是评估这个理论和经验基础上的多组分实施程序的过程和结果，该程序旨在促进常规癌症护理中的 SDM。
我们使用了一个渐进式楔形设计，这是一种集群随机对照试验的变体。要实施的干预措施是 SDM。一个综合性癌症中心的三个参与诊所将被随机分配，并按照时间延迟的顺序接受多组分 SDM 实施程序。该程序包括以下策略：（a）卫生保健专业人员的 SDM 培训，（b）医生的个体辅导，（c）患者激活策略，（d）提供患者信息材料和决策辅助工具，（e）修订诊所的质量管理文件，以及（f）对多学科团队会议当前组织形式的批判性反思。我们将进行混合方法的结果和过程评估。结果评估将包括四个测量点。主要结果是通过 9 项共享决策问卷调查来衡量的 SDM 采用情况。还将评估一系列其他实施结果（即可接受性、实施变革的准备情况、适当性、渗透度）。实施过程将通过利益相关者访谈和现场记录进行评估。如果有必要，这将允许对干预措施进行调整。
这是在德国癌症护理中进行的首次关于 SDM 常规实施的大型研究。我们预计将在参与的诊所中促进 SDM 的实施。通过使用理论和经验基础的方法获得的研究结果，可以为其他 SDM 实施研究和国家和国际卫生政策的制定提供信息。
clinicaltrials.gov，NCT03393351。于 2018 年 1 月 8 日注册。
