Project Overview

This project is an administrative supplement to R01HL133793 (CV Wizard: Does a Prioritized, Point-of-Care Clinical Decision Support Tool Improve Guideline-Based CVD Risk Factor Control in Safety Net Clinics?). The NOT-MH-20-053 will research the pandemic’s secondary health effects in populations impacted by health disparities and disruptions in care provision, and on the role of digital health interventions in risk management. This work addresses those priorities. It also strengthens the parent grant’s responsiveness to PAR 15-279 (its funding mechanism) by addressing guideline-to-practice gaps in high-risk populations, and identifying uses of technology for patient engagement.

This supplement to the parent grant is requested in response to the unanticipated COVID-19 pandemic and its impact on primary care delivery nationwide, including our study clinics. Many providers shifted to virtual care (VC; i.e., telephone and video encounters) because of the pandemic: in the parent study’s clinics, rates of VC rose from <1% to >52% of all encounters between March and June 2020. Thus, research is now needed on: how the shift to VC affects cardiovascular disease (CVD) risk management; the shift’s impact on existing health disparities in vulnerable populations; and whether CVD care in VC can be enhanced by the use of patient-centered clinical decision support (CDS) tools. As our parent study is collecting longitudinal data on CVD risk management and the role of CDS in community health center (CHC) patients, we are poised to conduct research that addresses these knowledge gaps by studying CVD care quality and outcomes, and the role of patient-centered CDS, in the VC context.

The parent study is a trial of the uptake and impact of CV Wizard©, a CDS tool designed to support point-of-care, patient-engaged CVD risk management, in the CHC setting. CV Wizard provides an individualized, prioritized summary of a given patient’s reversible CVD risk, in the form of a low-literacy ‘patient view’ and a ‘provider view’ with care suggestion based on current national guidelines. Study activities took place as planned before the pandemic’s onset, including recruiting and randomizing 70 CHCs to staggered implementation of CV Wizard, implementing it in Arm 1 clinics, and completing data collection for Aim 1 analyses of the tool’s impact on CVD outcomes. CV Wizard’s implementation in Arm 2 clinics was delayed by five months due to the pandemic. In response to the pandemic-driven shift to VC, the CV Wizard tool and its training materials was adapted to enable its use in VC. This is part of the tool’s implementation in Arm 2 clinics beginning in mid-September 2020, and Arm 1 clinics were trained to use the tool in VC in August 2020. Preliminary results from Aim 1 analyses, underway as scheduled (involving data from before COVID-19) show an association between use of CV Wizard and significantly improved blood pressure control.

This project influences the current grant’s design and methods in the following ways. Aims 2-3 of the parent study involve understanding and addressing barriers to CV Wizard’s adoption and impact in the context of point-of-care encounters. This supplement will augment these Aims by assessing CVD prevention, and the role of patient-facing CDS, in the VC context. In brief, the work will extend the parent study by adding data collection and analyses that augment those planned and underway in the parent study. This will involve: 1) quantitative analyses of CVD risk management and outcomes when care is provided in VC versus in-person encounters, and whether patient-centered CDS moderates this relationship; and 2) mixed methods analyses of patient and provider perceptions of CVD care in VC, and the use of CV Wizard in VC.

Specifically, the analyses augment the parent study's Aim 2 by assessing how the shift to VC impacted CVD risk management in high-risk CHC patients, and Aim 3 by assessing how CV Wizard was used to support care quality and patient engagement in the VC context. These analyses will increase the influence and utility of the parent study’s results. Further, as the parent study is designed to assess CV Wizard’s adoption and impact on CVD risk management, the supplemental work is essential to this assessment given the unanticipated shift to VC.

 

Grant Number

3R01HL133793-04S1

Principal Investigator(s)

Research Aims

Many healthcare settings rapidly shifted to virtual care (VC; defined here as video or telephone clinical encounters) because of the COVID-19 pandemic. Little is known about whether or how the shift to VC is impacting CVD risk management in primary care. The potential detrimental impacts of this shift are particularly concerning in community health centers (CHCs), which serve vulnerable patients who face health disparities (e.g., higher rates of unmanaged CVD risk than in the general population). However, the impact of VC on disparities in CVD care quality and outcomes remains largely unexplored.


Our current study (R01HL133793) is a trial of the uptake and impact of CV Wizard© – a clinical decision support (CDS) tool that supports point-of-care, patient-engaged CVD risk management – in the CHC setting.

Aim 1 measures the tool’s impact on CVD risk in CHCs randomized to receive it in a staggered implementation with an 18-month comparison period; analyses are underway for this aim, and preliminary results suggest a positive impact on BP control when CV Wizard is used.

Aims 2-3 seek to understand barriers to CV Wizard’s uptake, impact, and sustainability. In the study’s 70 CHCs, located in 7 states, rates of VC changed from <1% to >52% of encounters between March and June 2020.

In response, we adapted CV Wizard for use in VC, and developed related workflows and training materials. As we are currently collecting longitudinal data on CVD risk management in these CHCs’ patients, we are poised to assess how the VC shift impacts CVD risk management in socioeconomically vulnerable patients, and how CVD-focused CDS may be used in VC.


While the proportion of VC primary care encounters is likely to decline as COVID infections ebb, this timeline is unknown. It is also likely that a substantial proportion of clinical encounters may continue via VC post- pandemic, especially if VC is shown to reduce costs or access barriers (e.g., for patients requiring frequent clinic visits to manage CVD risk). We will augment the planned analyses for Aims 2-3 of the parent study by assessing VC’s impact on CVD risk management in CHCs, and the role of patient-facing CDS in this context. We will:


Aim 2: Compare CVD risk management in high-risk patients at in-person vs. VC encounters, in the periods pre- and post-COVID’s onset.

Aim 2a: Conduct descriptive analyses of process outcomes, including: 1) Percentage of patient encounters that are in-person, VC by video, or VC by phone (encounter types); 2) Rates of missed and cancelled appointments, and appointment wait times, by encounter type; and 3) CV Wizard use when it is recommended, by encounter type.

Aim 2b: Conduct adjusted regression analyses of the association between type of encounter and primary outcomes, defined as rates of: 1) Out-of-date BP and A1c documentation (i.e., >6 months since last updated); 2) Action taken on care steps recommended per national guidelines at a given encounter (e.g., cardioprotective prescribing if indicated); and, among patients whose data are up to date, 3) Change in reversible CVD risk score between index visit and end of follow-up period; 4) Change in BP between index visit and end of follow-up (increased, decreased, or stayed the same); and 5) Of those with uncontrolled A1c (>8%) at index visit, percent with controlled A1c by end of follow-up period, and of those with controlled A1c at index visit, percent with a ‘relapse’ (lack of control) by end of follow-up period. We will also assess whether use of CV Wizard moderated the relationship between encounter type and these outcomes.

Aim 3: In a subset of study clinics (5 per arm, 10 total), explore how CV Wizard’s individualized, prioritized CVD risk summary is used in VC to guide care decisions and engage patients in shared decision-making. Using qualitative methods, we will interview a total of 40 primary care providers for whom CV Wizard was recommended at ≥3 VC encounters in the period post-COVID’s onset (3/1/20-8/31/21). We will explore how CVD preventive care takes place at VC encounters, how the VC format helps or hinders CVD risk management, how clinicians decide whether to use CV Wizard during VC, and how they use it in VC. We will also conduct remote interviews with 30 patients who had a VC encounter at which CV Wizard was used in the post-COVID period from these same clinics, to learn about their experiences.


The work enables the parent study to assess how the COVID-19-driven shift to VC impacts CVD risk management in CHC populations. This will strengthen the study’s responsiveness to PAR 15-279 (its funding mechanism) by addressing guideline-to-practice gaps and using technology to support patient engagement. It directly addresses NOT-MH-20-053 targets: research on the pandemic’s secondary health effects in populations impacted by health disparities and disruptions in care provision, and the impact of digital health interventions on CVD risk management. Results will: inform future efforts to harness VC to improve CVD outcomes and reduce disparities in these outcomes; have immediate impact by indicating how the shift to VC affects CVD care and outcomes, with implications for health policy and practice in and after the pandemic context; and support creating and disseminating a Guide to Managing CVD Risk in VC. The analyses are beyond the scope of the parent grant, so the requested supplement is necessary to support this work.