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Heart AttackCV_WIZARDNCT03001713

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

A study testing CV WIZARD in people with Heart Attack and Stroke, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Heart Attack, Stroke, Cardiovascular Diseases
What is being tested?
CV WIZARD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
22 Feb 2018to 28 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • -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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
CV WIZARD
Medical subject headings
Myocardial Infarction, Stroke, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CV WIZARDBehavioural

    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.

Study groups in NCT03001713
Study groupRoleWhat they receive
Arm 1: Immediate implementationActive comparator30 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.
Receives: Behavioral: CV WIZARD
Arm 2: Delayed implementationActive comparator30 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.
Receives: Behavioral: CV WIZARD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2016 (estimated)
  2. Study start22 Feb 2018
  3. Primary completion31 Mar 2020
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03001713
Sponsor's protocol ID
HL133793-01A1
Acronym
CV_WIZARD
Status last verified
Jan 2025
First submitted
14 Dec 2016
Last updated
11 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Boston D, Larson AE, Sheppler CR, O'Connor PJ, Sperl-Hillen JM, Hauschildt J, Gold R. Does Clinical Decision Support Increase Appropriate Medication Prescribing for Cardiovascular Risk Reduction? J Am Board Fam Med. 2023 Oct 11;36(5):777-788. doi: 10.3122/jabfm.2022.220391R2. Epub 2023 Sep 13.

    PubMed 37704387
  • Hauschildt J, Lyon-Scott K, Sheppler CR, Larson AE, McMullen C, Boston D, O'Connor PJ, Sperl-Hillen JM, Gold R. Adoption of shared decision-making and clinical decision support for reducing cardiovascular disease risk in community health centers. JAMIA Open. 2023 Mar 10;6(1):ooad012. doi: 10.1093/jamiaopen/ooad012. eCollection 2023 Apr.

    PubMed 36909848
  • 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.

    PubMed 35119463

Questions about this trial

What is this clinical trial studying?

A study testing CV WIZARD in people with Heart Attack and Stroke, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year Change in 10-year CVD Risk (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03001713, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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