Healthy Hearts in the Heartland

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Other: Point of Care; Other: Population Management

• Registration Number: NCT02598284
• Lead Sponsor: Northwestern University

Brief Summary

This study evaluates the ability of small primary care practices to 1) implement point-of-care and population management quality improvement strategies to improve cardiovascular quality of care (e.g., clinical decision support, patient education and counseling, or referral to smoking quit lines), and 2) implement the PopHealth performance measurement software to evaluate performance on the ABCS (aspirin when appropriate, blood pressure control, cholesterol management, and when applicable, smoking cessation) and allow regional benchmarking. This minimal risk study is a practice-randomized trial to determine a) whether point of care strategies improve ABCS performance measures compared to baseline, and b) whether adding locally tailored population management strategies to POC strategies improves performance on the ABCS measures more than POC strategies alone.

Detailed Description

The investigators specific aims are to:

1. Evaluate the ability of small practices in the investigators region to 1) implement point-of-care (POC) and population management (PM) quality improvement strategies to improve the ABCS, and 2) implement the popHealth quality measurement software to evaluate performance on the ABCS and allow regional benchmarking.

2. Conduct a practice-randomized trial to determine a) whether POC strategies improve ABCS performance measures (i.e. aspirin prescribing, blood pressure control, cholesterol management, and smoking cessation counseling) compared to baseline, and b) whether adding locally-tailored PM strategies to POC strategies improves performance on the ABCS measures more than POC strategies alone.

3. Deploy an open source quality measurement platform (popHealth) to establish a regional QI benchmark based on participating practice ABCS measures and enable longitudinal tracking of electronic clinical quality measures (eCQMs) across the investigators region. The investigators will perform a mixed-methods evaluation to examine changes in practices' perceived capacity for quality improvement and whether access to comparative quality data within a region improves the capacity of practices to sustain their quality improvement program around the ABCS and provides a long-term framework for practices to implement new QI activities.

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Study Start: 2016-01
• Primary Completion: 2018-05
• Study Completion: 2018-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• Providers practicing in Wisconsin, Illinois, and Indiana.
• Practice is adult primary care-focused; [Further defined: health care organization dedicated to the provision of primary care, and a significant proportion of their patients are adults. Includes, but not limited to, family medicine, general internal medicine, general practice, geriatricians, nurse practitioners and physician assistants.]
• Practice has 20 or fewer primary care providers; [Community health centers with 20 or fewer lead clinicians may be included; multi-specialty practices that provide primary care and have ≤ 20 lead clinicians may be included.]
• Providers must provide informed consent.

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Exclusion Criteria

• Non-English speaking providers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POC + Population Managment (PM)	Point of Care	Clinics will receive facilitation to implement point-of-care (POC) quality improvement strategies as well as population management (PM) strategies to accelerate performance on ABCS clinical measures. Strategies in this arm will occur both at the clinical encounter and strategies aimed at the time between clinical encounters.
Point of Care (POC) Only	Point of Care	Clinics will receive facilitation to implement point-of-care (POC) quality improvement strategies to accelerate performance on ABCS clinical measures. All strategies will focus on aspects of the clinical encounter.
POC + Population Managment (PM)	Population Management	Clinics will receive facilitation to implement point-of-care (POC) quality improvement strategies as well as population management (PM) strategies to accelerate performance on ABCS clinical measures. Strategies in this arm will occur both at the clinical encounter and strategies aimed at the time between clinical encounters.

Primary Outcome Measures

Name	Time	Method
Change in appropriate aspirin prescribing from baseline to 12 months	12 months	Measured using electronic health record data. Patients age ≥ 18 with eligible encounters during measurement period (year prior and including measurement date) with IVD diagnosis on active problem list (on measurement date) or visit diagnosis (on or within 1 year prior to measurement date) who have aspirin prescribed.
Change in clinical performance on smoking cessation from baseline to 12 months	12 months	Measured using electronic health record data. The proportion of patients ≥ 18 with eligible encounters during the study period who have an assessment of tobacco use recorded. Then, among patients who report using tobacco, the proportion who have received a tobacco cessation intervention.
Change in clinical performance on blood pressure control from baseline to 12 months	12 months	Measured using electronic health record data. The proportion of adult (age 18-85) patients with hypertension with blood pressure \<140/90
Change in clinical performance on cholesterol management from baseline to 12 months	12 months	Measured using electronic health record data. The proportion of adult patients who are eligible for statins with a stain prescription on active medication list. Eligible patients for this measure are (1) Patients age ≥ 21 with an ASCVD diagnosis on problem list and (2) Patients age 40-75 with eligible encounters during the study period and diabetes on active problem list or as a visit diagnosis.

Secondary Outcome Measures

Name	Time	Method
Capacity for Quality Improvement	12 months	Collected via Change Process Capability Questionnaire (CPCQ)

Trial Locations

Locations (5)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Telligen; 🇺🇸 Oak Brook, Illinois, United States

MetaStar; 🇺🇸 Madison, Wisconsin, United States

Northern Illinois University (NIU); 🇺🇸 DeKalb, Illinois, United States

Purdue University; 🇺🇸 West Lafayette, Indiana, United States