CV Wizard: Does a Clinical Decision Support Tool Improve CVD Risk Factor Control in Safety Net Clinics? (CV_WIZARD)

CV Wizard: Does a Prioritized, Point-of-Care Clinical Decision Support Tool Improve Guideline-Based CVD Risk Factor Control in Safety Net Clinics?

This project aims to reduce disparities in cardiovascular disease (CVD) risk factor control and in rates of heart attacks and strokes among the low-income, racially / ethnically diverse Americans who receive primary care at safety net community health centers (CHCs). To achieve this important objective, the investigators will adapt a successful clinical decision support (CDS) system currently used in CVD care at several large, integrated health care systems, to meet the patient needs and workflow processes of 60 CHCs. The investigators will determine if use of this CDS improves CVD care, reduces disparities in CVD care and outcomes, and increases patient engagement in CVD treatment choices, in CHCs. Results of this randomized trial will help accelerate the translation of major investments in health informatics systems into substantial clinical benefits for large numbers of high-risk, low-income patients. Results will also provide a template for CVD care improvement that can be spread to other CHCs and extended to other clinical conditions.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Stroke; Heart Attack
• Intervention / Treatment: Behavioral: CV WIZARD

Detailed Description

The investigators seek to learn whether clinical decision support (CDS) systems from well-resourced care settings are effective in safety net community health centers (CHCs), and how to enhance such cross-setting implementation. Thus, the investigators propose a clinic-randomized, pragmatic trial of the uptake and impact of the 'CV Wizard' CDS tool in 60 CHCs that share a linked electronic health record. CV Wizard summarizes each patient's reversible CVD risks, generates prioritized, guideline-based care recommendations based on those risks, and shows these in a 'provider view' and a 'patient view,' enabling patient engagement. Use rates and satisfaction with this CDS were high in the large healthcare delivery system where it was developed and tested. The investigators will: study its impact in the CHC setting, assess uptake of the CDS system, assess strategies for integrating it into CHC workflows, and its impact on patients' CVD risk and risk factor management. The investigators hypothesize that this cutting-edge CDS will improve rates of guideline-based CVD preventive care in CHC patients, who experience disparities in CVD risk factors, care and outcomes. The 60 study clinics will be members of OCHIN, Inc., a non-profit health center-controlled network and national leader in health information technology for CHCs. OCHIN's leadership enthusiastically supports the proposed work and will help ensure that recruitment goals are met. The investigators will partner with stakeholders / medical leadership from OCHIN's member clinics at every step, via existing structures. This study addresses gaps in guideline-based CVD care in high-risk populations, using targeted, multi-level strategies; considers setting-specific needs; tests how CDS affects guideline implementation in community clinics; and uses technology to support patient engagement. Results will yield knowledge about providing CHCs with cutting-edge CDS, and associated impacts on CVD disparities. The innovative study is the second trial to implement CDS tools from private care settings in CHCs, and the first to do so with complex CDS tools that address a range of CVD risk management guidelines, make prioritized care recommendations, and facilitate point-of-care patient engagement. Results could lead to substantial improvements in CVD prevention, care, and outcomes in CHCs nationwide.

Our overarching aims are to:

Aim 1. Conduct a clinic-randomized trial of the impact of an evidence-based point-of-care CDS system on (i) overall CVD risk scores, and (ii) control of individual CVD risks (blood pressure; HbA1c, lipid levels; aspirin use; smoking; body mass index), among high CVD risk CHC adult patients. H1: High CVD risk patients in Arm 1 CHCs will have significantly lower overall CVD risk scores over a 12-month post-index visit period, compared to those in Arm 2 CHCs. H2: High CVD risk patients in Arm 1 CHCs who have poor control of specific CVD risk factors at an index visit will have significantly better control of those factors over a 12 month post-index visit period, compared to those in Arm 2 CHCs. H3: Disparities in specific CVD risk factor control between CHC patients' versus national CVD risk factor control rates will be significantly reduced by 18 months post-implementation in each Arm (secondary analysis).

Aim 2. Develop and hone need-based implementation support protocols to help Arm 1 CHCs implement the CV Wizard CDS system into their standard workflows; assess whether use of the protocols developed for Arm 1 CHCs accelerates implementation and adoption of the CDS system in the Arm 2 CHCs. H4: CDS uptake into CHC workflows will be significantly faster in Arm 2 CHCs than in Arm 1 CHCs.

Aim 3. Conduct a mixed methods process evaluation, guided by the Technology Acceptance Model, to identify and address patient, provider, and delivery system barriers to uptake / impact of this CDS in CHCs.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult clinic attendees with high CVD risk, including women and minorities
• Persons aged 18-21 with high-CVD risk
• Some subjects with mental health conditions of various types

Exclusion Criteria:

-Children aged younger than 18

Note: The investigators are not enrolling patients for this clinic-randomized study, but rather studying the uptake and impact of a set of EHR-based clinical decision support tools into regular care at the participating clinics. In this clinic-randomized trial, the intervention / randomization are clinic level.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Immediate implementation; 30 safety net community health centers (CHCs) will be randomized to implement the sophisticated CV Wizard clinical decision support (CDS) system at the start of study year 2. Arm 1 CHCs will receive implementation support that will be pragmatically iterated to address any barriers to adoption / sustained use of the CDS that are identified through study activities. The investigators will apply these learnings to improve adoption rates in Arm 2.	Behavioral: CV WIZARD; This project will determine whether a sophisticated CDS system will be effective in CHCs. The innovative, point-of-care, web-based CDS system we will test ("CV Wizard") generates a guideline-based prioritized summary of each patient's major CVD risk factors, then presents patient and provider 'views' of this summary, with individualized care recommendations.
Active Comparator: Arm 2: Delayed implementation; 30 safety net community health centers (CHCs) will be randomized to implement the sophisticated CV Wizard clinical decision support (CDS) system 18 months later than Arm 1. The investigators will measure the intervention's impact on CVD risk factor control in CHCs.	Behavioral: CV WIZARD; This project will determine whether a sophisticated CDS system will be effective in CHCs. The innovative, point-of-care, web-based CDS system we will test ("CV Wizard") generates a guideline-based prioritized summary of each patient's major CVD risk factors, then presents patient and provider 'views' of this summary, with individualized care recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of CVD outcomes for patients in CHCs	Compare patients' CVD outcomes in the 30 Arm 1 vs. 30 Arm 2 CHCs, in months 13-30 (Aim 1); assess whether the revised implementation support materials expedite CDS adoption (Aim 2); and use mixed methods to identify multi-level barriers / facilitators to adoption of the CDS tool (Aim 3).	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach: Encounters affected	% clinic encounters where CV Wizard suggests running the full risk assessment tool, i.e., identified a target patient.	Up to 36 months
Effectiveness (impact): Patient outcomes - 10 year pooled ASCVD risk score	(i) ASCVD risk score (American College of Cardiology-ACC/ American Heart Association - AHA) 10-year pooled ASCVD risk score, 40-75 year olds	Up to 36 months
Effectiveness (impact): Patient outcomes - Framingham 30-year CVD risk score	(i) Framingham 30-year CVD risk score, 20-39 year olds.	Up to 36 months
Effectiveness (impact): Patient outcomes - last BP ≤140/90	(ii) Control of individual CVD risk factors: last BP ≤140/90	Up to 36 months
Effectiveness (impact): Patient outcomes - last A1c≤8	(ii) Control of individual CVD risk factors: last A1c≤8	Up to 36 months
Effectiveness (impact): Patient outcomes - last LDL<100	(ii) Control of individual CVD risk factors: last LDL<100	Up to 36 months
Effectiveness (impact): Patient outcomes - appropriate aspirin use	(ii) Control of individual CVD risk factors: appropriate aspirin use	Up to 36 months
Effectiveness (impact): Patient outcomes - not current smoker	(ii) Control of individual CVD risk factors: not current smoker	Up to 12 months
Effectiveness (impact): Patient outcomes - last BMI ≤25	(ii) Control of individual CVD risk factors: last BMI≤25	Up to 36 months
Effectiveness (impact): Patient outcomes - appropriate cardioprotective medications	(ii) Control of individual CVD risk factors: appropriate cardioprotective prescriptions (e.g., statins).	Up to 36 months
Adoption: CDS uptake	% of encounters where care team member opts to run the CV Wizard risk assessment.	Up to 36 months
Implementation: User perceptions	Perceived ease of use, usefulness, acceptability of CV Wizard; intent to use it.	Up to 36 months
Maintenance over time	All measures over 2.5 years of follow-up, Arm 1; 1.5 years, Arm 2.	Up to 36 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: HealthPartners Institute; OCHIN, Inc.
• Investigators: Principal Investigator: Rachel Gold, PhD, MPH, Kaiser Permanente

Publications and helpful links

General Publications

• Gold R, Larson AE, Sperl-Hillen JM, Boston D, Sheppler CR, Heintzman J, McMullen C, Middendorf M, Appana D, Thirumalai V, Romer A, Bava J, Davis JV, Yosuf N, Hauschildt J, Scott K, Moore S, O'Connor PJ. Effect of Clinical Decision Support at Community Health Centers on the Risk of Cardiovascular Disease: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2146519. doi: 10.1001/jamanetworkopen.2021.46519.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimated): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Myocardial Infarction; Cardiovascular Diseases
• Other Study ID Numbers: HL133793-01A1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No