Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP).
Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP).
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DOI：
10.1186/s43058-021-00145-6
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发表时间：
2021-04-21
影响因子：
--
通讯作者：
Montori VM
中科院分区：
文献类型：
--
作者：
Ridgeway JL;Branda ME;Gravholt D;Brito JP;Hargraves IG;Hartasanchez SA;Leppin AL;Gomez YL;Mann DM;Nautiyal V;Thomas RJ;Behnken EM;Torres Roldan VD;Shah ND;Khurana CS;Montori VM
心血管（CV）事件的一级预防在CV风险较高的人群中通常强度较低，反之亦然。临床实践指南建议临床医生和患者使用共同决策（SDM）来制定有效可行的预防计划，该计划与每个人的CV风险和知情偏好一致。然而，SDM在实践中并不经常发生。本研究旨在将SDM决策工具（CV预防选择）整合到美国三个不同医疗保健系统的常规护理中，并研究促进其采用和常规使用的策略。这是一项混合方法、混合III型阶梯楔形分组随机研究，旨在评估（a）实施战略对SDM吸收和利用的有效性和（B）SDM导致风险一致的预防计划的程度。形成性评价方法，包括临床医生和利益相关者访谈和调查，将确定可能影响CV预防选择的可行性、可接受性和采用以及常规护理中CV预防选择的正常化的因素。将利用执行便利使执行战略适合当地需要，并将系统地调整和跟踪执行战略，以便进行评估和完善。电子健康记录数据将用于评估实施和有效性结局，包括CV预防选择范围、采用、实施、维护和有效性（以风险一致性护理计划衡量）。将使用视频记录的临床遭遇和患者调查的样本来评估保真度。该研究采用了三种理论方法：一个决定性的框架，呼吁注意可能促进或抑制实施结果的因素类别（实施研究的综合框架），一个实施理论，指导解释或理解的因果关系对实施结果的影响（规范化过程理论），和一个评估框架（RE-AIM）。到项目结束时，我们预计将（a）确定最有效的实施策略，将SDM嵌入常规实践中，（B）估计SDM在初级保健中实现可行且风险一致的CV预防的有效性。ClinicalTrials.gov，NCT 04450914。Posted June 30，2020本研究于2020年4月17日获得伦理批准。当前试验方案为第2版（2021年2月17日批准）。在提交时，首例受试者尚未入组。
The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person’s CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV Prevention Choice) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use. This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV Prevention Choice as well as normalization of CV Prevention Choice in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV Prevention Choice reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM). By the project’s end, we expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care. ClinicalTrials.gov, NCT04450914. Posted June 30, 2020 This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.
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影响因子：
12.7
作者：
Glasgow, RE;Vogt, TM;Boles, SM
通讯作者：
Boles, SM
影响因子：
3.2
作者：
Hsieh, HF;Shannon, SE
通讯作者：
Shannon, SE
DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
影响因子：
4
作者：
Bunger AC;Powell BJ;Robertson HA;MacDowell H;Birken SA;Shea C
通讯作者：
Shea C
影响因子：
3.7
作者：
Boyd, Meredith R.;Powell, Byron J.;Lewis, Cara C.
通讯作者：
Lewis, Cara C.