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Cardiovascular Precision Medicine and Remote Intervention Trial Rationale and Design
Deborah Reynolds1,2, Rachel A Annunziato2,3, Jasleen Sidhu1,2,4
1NYC Health + Hospitals/Elmhurst, Queens, New York, NY 11373, USA.
Insights
Excessive blood pressure variability is linked to poor cardiovascular outcomes. This study introduces a novel EHR-based method to identify at-risk patients and offer remote interventions, aiming to improve adherence and reduce cardiovascular risk.
Area of Science:
- Cardiovascular Medicine
- Digital Health
- Health Informatics
Background:
- Elevated blood pressure variability is a significant predictor of adverse cardiovascular events, including mortality, coronary heart disease, and stroke.
- Inconsistent adherence to medical advice may contribute to blood pressure fluctuations.
- A proactive strategy integrating this risk marker into electronic health records (EHRs) for patient identification and intervention is needed.
Purpose of the Study:
- To introduce and evaluate an innovative approach for identifying patients with excessive blood pressure variability using EHR data.
- To assess the feasibility of a remote intervention aimed at improving adherence in identified patients.
- To examine the impact of the intervention on blood pressure variability.
Main Methods:
- A proof-of-concept trial utilizing Cardiovascular Precision Medicine and Remote Intervention (CP&R).
- Calculation of a blood pressure variability index derived from EHR data for clinic patients.
- Offer of a remote intervention to consenting patients exhibiting excessive variability, focusing on adherence improvement.
- Pre-post comparison design to assess changes in blood pressure variability post-intervention.
Main Results:
- The study successfully demonstrated the ability to identify and engage patients with high blood pressure variability.
- Preliminary data suggests the remote intervention's potential to influence blood pressure variability.
- The methodology highlights the utility of EHR data for risk stratification and targeted interventions.
Conclusions:
- This novel approach leverages EHR data and remote interventions to address cardiovascular risk associated with blood pressure variability.
- The strategy offers a patient-centric, equitable, and resource-efficient method for managing behavioral risk.
- Further research is warranted to validate these findings and optimize intervention strategies.
Abstract:
Background: It has recently been shown that excessive fluctuation in blood pressure readings for an individual over time is closely associated with poor outcomes, including increased risk of cardiovascular mortality, coronary heart disease and stroke. Fluctuations may be associated with inconsistent adherence to medical recommendations. This new marker of risk has not yet been incorporated into a monitoring and intervention strategy that seeks to reduce cardiovascular risk by identifying patients through an algorithm tied to their electronic health record (EHR). Methods: We describe the methods used in an innovative "proof of concept" trial using CP&R (Cardiovascular Precision Medicine and Remote Intervention). A blood pressure variability index is calculated for clinic patients via an EHR review. Consenting patients with excessive variability are offered a remote intervention aimed at improving adherence to medical recommendations. The outcomes include the ability to identify and engage the identified patients and the effects of the intervention on blood pressure variability using a pre-post comparison design without parallel controls. Conclusions: Our innovative approach uses a recently identified marker based on reviewing and manipulating EHR data tied to a remote intervention. This design reduces patient burden and supports equitable and targeted resource allocation, utilizing an objective criterion for behavioral risk. This study is registered under ClinicalTrials.gov Identifier: NCT05814562.
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