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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03001713
Acronym
CV_WIZARD
Enrollment
70
Registered
2016-12-23
Start date
2018-02-22
Completion date
2024-02-28
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Attack, Stroke

Brief summary

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.

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.

Interventions

BEHAVIORALCV 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.

Sponsors

OCHIN, Inc.
CollaboratorOTHER
HealthPartners Institute
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
1-year Change in 10-year CVD Risk12 months10-year CVD risk was estimated using the American College of Cardiology/American Heart Association pooled risk equations, which include age, race and ethnicity, sex, systolic BP, total cholesterol level, high-density lipoprotein cholesterol level, and diabetes, smoking, and antihypertensive medication status.
1-year Change in Reversible CVD Risk12 monthsReversible CVD risk was calculated as follows: Standardized equations estimated the potential reduction in CVD risk if a patient's uncontrolled risk factors reached evidence-based thresholds. Change was calculated by subtracting reversible risk at follow-up from that at index visit; negative values represent favorable changes.

Countries

United States

Participant flow

Recruitment details

41 organizations (761 clinics) were assessed for eligibility. Of those, 26 organizations (691 clinics) either did not meet inclusion criteria (n=556 clinics) or declined participation/did not volunteer (n=135 clinics). A total of 15 organizations (70 clinics) were randomized. While individual patients were not enrolled for this clinic-randomized study, patient data from enrolled clinics was used in analyses. Clinic staff interviews not included in primary outcome analyses, so not reflected here.

Participants by arm

ArmCount
Arm 1: Intervention (Immediate Implementation)
42 safety net community health centers (CHCs) from 8 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS). Arm 1 CHCs received implementation support that was pragmatically iterated to address any barriers to adoption/sustained use of the CDS that were identified through study activities. The investigators will apply the learnings from Arm 1 implementation with the goal of improving adoption rates in Arm 2.
11,159
Arm 2: Control (Delayed Implementation)
28 safety net community health centers (CHCs) from 7 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS) system 18 months later than Arm 1 clinics.
7,419
Total18,578

Baseline characteristics

CharacteristicTotalArm 2: Control (Delayed Implementation)Arm 1: Intervention (Immediate Implementation)
10-year CVD risk16.0 percent risk of CVD
STANDARD_DEVIATION 12.5
16.6 percent risk of CVD
STANDARD_DEVIATION 12.8
15.6 percent risk of CVD
STANDARD_DEVIATION 12.3
Age, Continuous58.7 years
STANDARD_DEVIATION 8.8
59.3 years
STANDARD_DEVIATION 8.7
58.3 years
STANDARD_DEVIATION 8.9
Race/Ethnicity, Customized
Hispanic
3981 Participants1196 Participants2785 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
3351 Participants966 Participants2385 Participants
Race/Ethnicity, Customized
Non-Hispanic Other
1038 Participants380 Participants658 Participants
Race/Ethnicity, Customized
Non-Hispanic White
8434 Participants4543 Participants3891 Participants
Race/Ethnicity, Customized
Unknown
1774 Participants334 Participants1440 Participants
Region of Enrollment
United States
18578 participants7419 participants11159 participants
Reversible CVD Risk8.6 percent reversible risk of CVD
STANDARD_DEVIATION 9.4
9.7 percent reversible risk of CVD
STANDARD_DEVIATION 10
7.9 percent reversible risk of CVD
STANDARD_DEVIATION 9
Sex: Female, Male
Female
9490 Participants3618 Participants5872 Participants
Sex: Female, Male
Male
9088 Participants3801 Participants5287 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

1-year Change in 10-year CVD Risk

10-year CVD risk was estimated using the American College of Cardiology/American Heart Association pooled risk equations, which include age, race and ethnicity, sex, systolic BP, total cholesterol level, high-density lipoprotein cholesterol level, and diabetes, smoking, and antihypertensive medication status.

Time frame: 12 months

ArmMeasureValue (MEAN)
Arm 1: Intervention (Immediate Implementation)1-year Change in 10-year CVD Risk0.4 percent risk of CVD
Arm 2: Control (Delayed Implementation)1-year Change in 10-year CVD Risk0.2 percent risk of CVD
Primary

1-year Change in Reversible CVD Risk

Reversible CVD risk was calculated as follows: Standardized equations estimated the potential reduction in CVD risk if a patient's uncontrolled risk factors reached evidence-based thresholds. Change was calculated by subtracting reversible risk at follow-up from that at index visit; negative values represent favorable changes.

Time frame: 12 months

ArmMeasureValue (MEAN)
Arm 1: Intervention (Immediate Implementation)1-year Change in Reversible CVD Risk0.4 percent reversible risk of CVD
Arm 2: Control (Delayed Implementation)1-year Change in Reversible CVD Risk-0.1 percent reversible risk of CVD

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026