Clinical trial NCT02598284: Healthy Hearts in the Heartland
Official title: Midwest Small Practice Care Transformation Research Alliance (MSPCTRA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Preventive measures
Quality Improvement
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Alliance of Chicago Community Health Services
name: American Medical Association
name: Illinois Department of Public Health
name: MetaStar, Inc.
name: Northern Illinois University
name: Northwestern Medical Group
name: Purdue University
name: Telligen, Inc.
name: University of Chicago
First posted: 2015-11-05
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Exclusion Criteria:

* Non-English speaking providers

Primary outcomes:
measure: Change in appropriate aspirin prescribing from baseline to 12 months
timeFrame: 12 months
measure: Change in clinical performance on blood pressure control from baseline to 12 months
timeFrame: 12 months
measure: Change in clinical performance on cholesterol management from baseline to 12 months
timeFrame: 12 months
measure: Change in clinical performance on smoking cessation from baseline to 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Capacity for Quality Improvement
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: DeKalb
country: United States
facility: Northern Illinois University (NIU)
state: Illinois
city: Oak Brook
country: United States
facility: Telligen
state: Illinois
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
city: Madison
country: United States
facility: MetaStar
state: Wisconsin
Study officials:
References:
citation: Ciolino JD, Jackson KL, Liss DT, Brown T, Walunas TL, Murakami L, Chung I, Persell SD, Kho AN. Design of healthy hearts in the heartland (H3): A practice-randomized, comparative effectiveness study. Contemp Clin Trials. 2018 Aug;71:47-54. doi: 10.1016/j.cct.2018.06.004. Epub 2018 Jun 2.