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Multicomponent intervention to improve blood pressure management in chronic kidney disease: a protocol for a
John L Kilgallon1, Michael Gannon2, Zoe Burns2
1Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA jkilgallon@bwh.harvard.edu.
Insights
This study integrated behavioral economics and user-centered design to manage uncontrolled hypertension in chronic kidney disease patients. The intervention aims to improve blood pressure control in primary care settings.
Area of Science:
- Clinical Medicine
- Health Services Research
- Behavioral Economics
Background:
- Uncontrolled hypertension (HTN) in patients with chronic kidney disease (CKD) poses significant health risks.
- Effective management strategies for HTN in CKD patients are crucial, particularly in primary care settings.
- Current management approaches may benefit from integrating behavioral and user-centered design principles.
Purpose of the Study:
- To develop and test a multicomponent intervention for managing uncontrolled hypertension in chronic kidney disease patients.
- To incorporate behavioral economic principles and user-centered design into a clinical decision support system.
- To improve the recognition and management of HTN in CKD patients within primary care.
Main Methods:
- A multicenter, pragmatic, cluster-randomized controlled trial involving 184 clinicians across 15 primary care practices.
- Development of a clinical decision support system synthesizing electronic health record data to identify and recommend management for HTN in CKD.
- Primary endpoint: change in mean systolic blood pressure from baseline to 6 months, analyzed using the Reach Effectiveness Adoption Implementation Maintenance framework.
Main Results:
- The study aims to validate an intervention combining EHR data for HTN in CKD recognition and care recommendations.
- Effectiveness of the intervention in improving blood pressure control will be tested.
- Implementation data will be collected to facilitate broader dissemination.
Conclusions:
- The developed intervention has the potential to improve the management of uncontrolled hypertension in chronic kidney disease patients.
- Integrating behavioral economics and user-centered design can enhance clinical decision support systems.
- Findings will inform the dissemination and implementation of effective HTN-CKD management strategies in primary care.
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.
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