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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Heart Attack, Stroke, Cardiovascular Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Arm 1: Immediate implementation | Active comparator | 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. Receives: Behavioral: CV WIZARD |
| Arm 2: Delayed implementation | Active comparator | 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. Receives: Behavioral: CV WIZARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted23 Dec 2016 (estimated)
- Study start22 Feb 2018
- Primary completion31 Mar 2020
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- OCHIN, Inc., HealthPartners Institute
- Responsible party
- Sponsor
- Investigators
- Rachel Gold, PhD, MPH, Principal investigator, Kaiser Permanente
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 37704387Hauschildt 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 36909848Gold 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03001713
- Acronym / sponsor ID
- CV_WIZARD / HL133793-01A1
- Conditions
- Heart Attack, Stroke, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- OCHIN, Inc., HealthPartners Institute
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 11 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Immediate implementation | Active comparator | Behavioral: CV WIZARD30 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. |
| Arm 2: Delayed implementation | Active comparator | Behavioral: CV WIZARD30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CV WIZARDThis 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. | Behavioural | Arm 1: Immediate implementation, Arm 2: Delayed implementation |
Primary outcome
1-year Change in 10-year CVD Risk
Time frame: 12 months
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.
1-year Change in Reversible CVD Risk
Time frame: 12 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37704387Boston 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.
- Derived from this study: PubMed 36909848Hauschildt 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.
- Derived from this study: PubMed 35119463Gold 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Gold, PhD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
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.