| Autor: |
David R Lee, Matthew Chenoweth, Linh H Chuong, Chad W Villaflores, Miguel Cuevas, Sitaram Vangala, Jeff Borenstein, Hannah Kwak, Chidinma Chima-Melton, Maria Han, Samuel A Skootsky, Therese Chan Tack, Linda Branagan, Heather Martin, Reshma Gupta, Linda Phan, Michael A Sanchez, Mina M Malaak, Anna Dermenchyan, Kandyce N Pearson, Marine Altunyam, Peter F Barakat, Ray Pablo, Catherine Sarkisian |
| Rok vydání: |
2023 |
| DOI: |
10.2196/preprints.45915 |
| Popis: |
BACKGROUND Hypertension is a major contributor of various adverse health outcomes. Although prior studies have shown benefits of home blood pressure monitoring over office-based measurements, there is limited evidence comparing the effectiveness of whether a blood pressure monitor integrated into the electronic health record is superior to a non-integrated blood pressure monitor. OBJECTIVE In this paper, we describe the protocol for a pragmatic multisite implementation of a quality improvement initiative directly comparing integrated to non-integrated blood pressure monitors for hypertension improvement. METHODS This is a 12-month randomized, comparative effectiveness study conducted at three large academic health centers across California. The three sites will enroll a total of 660 participants (approximately n=220 per site) with 330 in the integrated blood pressure monitor arm and 330 in the non-integrated blood pressure control arm. The primary outcome of this study will be absolute difference in systolic blood pressure in mmHg from enrollment to 6 months. Secondary outcome measures include binary measures of hypertension (controlled vs uncontrolled), hypertension-related health complications, hospitalizations, and death. The list of possible participants will be generated from a central data warehouse. Randomization will occur after enrollment into the study. Participants will use their assigned blood pressure monitor and join site-specific hypertension interventions. Cross-site learning will occur at regular all-site meetings facilitated by the UCLA Value-Based Care Research Consortium. A pre-study and post-study questionnaire will be conducted to further evaluate participant perspectives regarding their blood pressure monitor. Linear mixed effects models will be used to compare the primary outcome measure between study arms. Mixed effects logistic regression models will be used to compare secondary outcome measures between study arms. RESULTS The study will start enrolling participants in the second quarter of 2023 and complete by first half 2024. Results will be published by end of 2024. CONCLUSIONS This pragmatic trial will contribute to the growing field of chronic care management using remote monitoring by answering whether a hypertension intervention coupled with an electronic health record integrated home blood pressure monitor improves patients’ hypertension better than a hypertension intervention with a non-integrated blood pressure monitor. The outcomes of this study may help health system decision-makers determine whether to invest in integrated blood pressure monitors for vulnerable patient populations. CLINICALTRIAL The ClinicalTrials.gov ID for this study is "NCT05390502." It was registered 05/20/2022. Protocol ID is 22000036. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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