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

NCT03001713 | Completed Results DMC

• 1 other identifier: HL133793-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Attack; Stroke; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Study Arms (2)

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.

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.

Behavioral: CV WIZARD

Interventions

CV WIZARD BEHAVIORAL

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.

Arm 1: Immediate implementation; Arm 2: Delayed implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• OCHIN, Inc.: collaborator
• HealthPartners Institute: collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (3)

• 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.

  PMID: 37704387 DERIVED

• 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.

  PMID: 36909848 DERIVED

• 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.

  PMID: 35119463 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Stroke; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Rachel Gold, PhD MPH
• Organization: Kaiser Permanente Center for Health Research

rachel.gold@kpchr.org

503-335-2400

Study Officials

• Rachel Gold, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 23, 2016
• Study Start: February 22, 2018
• Primary Completion: March 31, 2020
• Study Completion: February 28, 2024
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2025-01

Locations

US (1)