TY - JOUR
T1 - Multicomponent intervention to improve blood pressure management in chronic kidney disease
T2 - A protocol for a pragmatic clinical trial
AU - Kilgallon, John L.
AU - Gannon, Michael
AU - Burns, Zoe
AU - McMahon, Gearoid
AU - Dykes, Patricia
AU - Linder, Jeffrey
AU - Bates, David Westfall
AU - Waikar, Sushrut
AU - Lipsitz, Stuart
AU - Baer, Heather J.
AU - Samal, Lipika
N1 - Funding Information:
Funding This work was supported by a grant from the National Institutes of Health (5R01DK116898-03). This funding was used to support salaries and wages, personnel costs, materials and supplies, travel and publication fees related to this project. Dr Linder is supported by a contract from the Agency for Healthcare Research and Quality (HHSP233201500020I) and grants from the National Institute on Aging (R33AG057383, R33AG057395, P30AG059988, R01AG069762), the Agency for Healthcare Research and Quality (R01HS026506, R01HS028127) and the Peterson Center on Healthcare.
Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration number NCT03679247.
AB - Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration number NCT03679247.
KW - chronic renal failure
KW - clinical trials
KW - hypertension
KW - primary care
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U2 - 10.1136/bmjopen-2021-054065
DO - 10.1136/bmjopen-2021-054065
M3 - Article
C2 - 34937722
AN - SCOPUS:85122285841
SN - 2044-6055
VL - 11
JO - BMJ open
JF - BMJ open
IS - 12
M1 - e054065
ER -
