Multicomponent intervention to improve blood pressure management in chronic kidney disease: a protocol for a pragmatic clinical trial.
Multicomponent intervention to improve blood pressure management in chronic kidney disease: a protocol for a pragmatic clinical trial.
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DOI：
10.1136/bmjopen-2021-054065
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发表时间：
2021-12-22
期刊：
影响因子：
2.9
通讯作者：
Samal L
中科院分区：
文献类型：
--
作者：
Kilgallon JL;Gannon M;Burns Z;McMahon G;Dykes P;Linder J;Bates DW;Waikar S;Lipsitz S;Baer HJ;Samal L
这项研究的目的是将行为经济学原则和以用户为中心的设计原则纳入到初级保健中管理慢性肾脏疾病(CKD)中的未控制高血压(HTN)的多组分干预中。这是一个多中心、务实、对照的试验群--在布里格姆和妇女实践研究网络的15个实践的临床医生层面上随机进行。在220名临床医生中，184名有资格参加，其余的被排除在外(看紧急护理或走访患者的住院医生和临床医生)；没有临床医生选择退出。干预措施包括一个基于行为经济学和以用户为中心的设计原则的临床决策支持系统，该系统将：(1)综合现有的实验室测试、用药指令和生命体征数据；(2)提高对CKD的认识；(3)提高对CKD患者失控HTN的认识；(4)提供基于证据的CKD和HTN管理建议。主要终点是基线和6个月之间的平均收缩压的变化。我们将使用REACH有效性采用实施维护框架。在这项研究的结论中，我们将：(1)验证一项结合实验室测试、用药记录和电子健康记录收集的临床信息的干预措施，以识别CKD患者的失控HTN并推荐护理过程，(2)测试所述干预措施的有效性，以及(3)收集有关干预措施实施的信息，这将有助于将干预措施传播到其他实践环境。布里格姆妇女医院的人类受试者机构审查委员会加快了对这项研究方案的审查和批准，数据安全监测委员会将确保试验的持续安全性。NCT03679247。
The purpose of this study is to incorporate behavioural economic principles and user-centred design principles into a multicomponent intervention for the management of uncontrolled hypertension (HTN) in chronic kidney disease (CKD) in primary care. This is a multicentre, pragmatic, controlled trial cluster-randomised at the clinician level at The Brigham and Women’s Practice -Based Research Network of 15 practices. Of 220 total clinicians, 184 were eligible to be enrolled, and the remainder were excluded (residents and clinicians who see urgent care or walk-in patients); no clinicians opted out. The intervention consists of a clinical decision support system based in behavioural economic and user-centred design principles that will: (1) synthesise existing laboratory tests, medication orders and vital sign data; (2) increase recognition of CKD, (3) increase recognition of uncontrolled HTN in CKD patients and (4) deliver evidence-based CKD and HTN management recommendations. The primary endpoint is the change in mean systolic blood pressure between baseline and 6 months compared across arms. We will use the Reach Effectiveness Adoption Implementation Maintenance framework. At the conclusion of this study, we will have: (1) validated an intervention that combines laboratory tests, medication records and clinical information collected by electronic health records to recognise uncontrolled HTN in CKD patients and recommend a course of care, (2) tested the effectiveness of said intervention and (3) collected information about the implementation of the intervention that will aid in dissemination of the intervention to other practice settings. The Human Subjects Institutional Review Board at Brigham and Women’s Hospital provided an expedited review and approval for this study protocol, and a Data Safety Monitoring Board will ensure the ongoing safety of the trial. NCT03679247.
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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：
2.9
作者：
Pellegrino, Beth;Schmidt, Rebecca J.
通讯作者：
Schmidt, Rebecca J.
DOI：
10.2215/cjn.04330418
发表时间：
2019-05-07
影响因子：
9.8
作者：
Sinha, Arjun A.;Agarwal, Rajiv
通讯作者：
Agarwal, Rajiv
DOI：
10.1053/j.ajkd.2013.03.018
发表时间：
2013-08
期刊：
American journal of kidney diseases : the official journal of the National Kidney Foundation
影响因子：
--
作者：
Taler SJ;Agarwal R;Bakris GL;Flynn JT;Nilsson PM;Rahman M;Sanders PW;Textor SC;Weir MR;Townsend RR
通讯作者：
Townsend RR
DOI：
10.1093/jamia/ocv192
发表时间：
2016-09-01
影响因子：
6.4
作者：
Malhotra, Sameer;Cheriff, Adam D.;Ancker, Jessica S.
通讯作者：
Ancker, Jessica S.