RESUMO
BACKGROUND: Hypertension is a major contributor to various adverse health outcomes. Although previous studies have shown the benefits of home blood pressure (BP) monitoring over office-based measurements, there is limited evidence comparing the effectiveness of whether a BP monitor integrated into the electronic health record is superior to a nonintegrated BP monitor. OBJECTIVE: In this paper, we describe the protocol for a pragmatic multisite implementation of a quality improvement initiative directly comparing integrated to nonintegrated BP monitors for hypertension improvement. METHODS: We will conduct a randomized, comparative effectiveness trial at 3 large academic health centers across California. The 3 sites will enroll a total of 660 participants (approximately n=220 per site), with 330 in the integrated BP monitor arm and 330 in the nonintegrated BP control arm. The primary outcome of this study will be the absolute difference in systolic BP in mm Hg 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 in the study. Participants will use their assigned BP monitor and join site-specific hypertension interventions. Cross-site learning will occur at regular all-site meetings facilitated by the University of California, Los Angeles Value-Based Care Research Consortium. A pre- and poststudy questionnaire will be conducted to further evaluate participants' perspectives regarding their BP 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 will be completed by the first half of 2024. Results will be published by the 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 BP monitor improves patients' hypertension better than a hypertension intervention with a nonintegrated BP monitor. The outcomes of this study may help health system decision makers determine whether to invest in integrated BP monitors for vulnerable patient populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT05390502; clinicaltrials.gov/study/NCT05390502. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45915.
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Importance: For patients discharged from the emergency department (ED), timely outpatient in-person follow-up is associated with improved mortality, but the effectiveness of telehealth as follow-up modality is unknown. Objective: To evaluate whether the rates of ED return visits and hospitalization differ between patients who obtain in-person vs telehealth encounters for post-ED follow-up care. Design, Setting, and Participants: This retrospective cohort study included adult patients who presented to either of 2 in-system EDs of a single integrated urban academic health system from April 1, 2020, to September 30, 2021; were discharged home; and obtained a follow-up appointment with a primary care physician within 14 days of their index ED visit (15 total days). Exposures: In-person vs telehealth post-ED discharge follow-up within 14 days. Main Outcomes and Measures: Multivariable logistic regression was used to estimate the odds of ED return visits (primary outcome) or hospitalization (secondary outcome) within 30 days of an ED visit based on the modality of post-ED discharge follow-up. Models were adjusted for age, sex, primary language, race, ethnicity, Social Vulnerability Index, insurance type, distance to the ED, ambulatory billing codes for the index visit, and the time from ED discharge to follow-up. Results: Overall, 12â¯848 patients with 16â¯987 ED encounters (mean [SD] age, 53 [20] years; 9714 [57%] women; 2009 [12%] Black or African American; 3806 [22%] Hispanic or Latinx; and 9858 [58%] White) were included; 11â¯818 (70%) obtained in-person follow-up, and 5169 (30%) obtained telehealth follow-up. Overall, 2802 initial ED encounters (17%) led to returns to the ED, and 676 (4%) led to subsequent hospitalization. In adjusted analyses, telehealth vs in-person follow-up visits were associated with increased rates of ED returns (28.3 [95% CI, 11.3-45.3] more ED returns per 1000 encounters) and hospitalizations (10.6 [95% CI, 2.9-18.3] more hospitalizations per 1000 encounters). Conclusions and Relevance: In this cohort study of patients in an urban integrated health care system, those with telehealth follow-up visits after an ED encounter were more likely to return to the ED and be hospitalized than patients with in-person follow-up. The use of telehealth warrants further evaluation to examine its effectiveness as a modality for continuing care after an initial ED presentation for acute illness.