Healthy Hearts in the Heartland

NCT ID: NCT02598284

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Point of Care (POC) Only

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.

Group Type EXPERIMENTAL

Point of Care

Intervention Type OTHER

Practice facilitators will work with practices to implement strategies to improve ABCS care during the patient encounter. Some examples of these types of quality improvement initiatives are electronic reminders and clinical decision support to prescribe aspirin or a statin at the time of a visit, improving how your practice collects blood pressure measures to increase clinicians' willingness to act on readings, or electronic reminders for nursing staff that there is no lipid panel in record and have a standing order to act on this.

POC + Population Managment (PM)

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.

Group Type EXPERIMENTAL

Point of Care

Intervention Type OTHER

Practice facilitators will work with practices to implement strategies to improve ABCS care during the patient encounter. Some examples of these types of quality improvement initiatives are electronic reminders and clinical decision support to prescribe aspirin or a statin at the time of a visit, improving how your practice collects blood pressure measures to increase clinicians' willingness to act on readings, or electronic reminders for nursing staff that there is no lipid panel in record and have a standing order to act on this.

Population Management

Intervention Type OTHER

Practice Facilitators will work with practices to both implement Point of Care strategies as well as population management strategies. These practices will use their EHR and/or receive training to use the popHealth software package, which works with data from the EHR, to generate lists of high-risk patients that need outreach for one of the ABCS domains (such as conducting outreach to patients who are not on aspirin who would benefit from this therapy).

Practices in this arm will receive the opportunity to link to community resources such as pharmacists who could assist patients with medication management or tobacco quit lines through the HealtheRx program.

Interventions

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Point of Care

Practice facilitators will work with practices to implement strategies to improve ABCS care during the patient encounter. Some examples of these types of quality improvement initiatives are electronic reminders and clinical decision support to prescribe aspirin or a statin at the time of a visit, improving how your practice collects blood pressure measures to increase clinicians' willingness to act on readings, or electronic reminders for nursing staff that there is no lipid panel in record and have a standing order to act on this.

Intervention Type OTHER

Population Management

Practice Facilitators will work with practices to both implement Point of Care strategies as well as population management strategies. These practices will use their EHR and/or receive training to use the popHealth software package, which works with data from the EHR, to generate lists of high-risk patients that need outreach for one of the ABCS domains (such as conducting outreach to patients who are not on aspirin who would benefit from this therapy).

Practices in this arm will receive the opportunity to link to community resources such as pharmacists who could assist patients with medication management or tobacco quit lines through the HealtheRx program.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Alliance of Chicago Community Health Services

OTHER

Sponsor Role collaborator

American Medical Association

OTHER

Sponsor Role collaborator

Illinois Department of Public Health

OTHER

Sponsor Role collaborator

MetaStar, Inc.

INDUSTRY

Sponsor Role collaborator

Northern Illinois University

OTHER

Sponsor Role collaborator

Northwestern Medical Group

OTHER

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role collaborator

Telligen, Inc.

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Abel Kho

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Northern Illinois University (NIU)

DeKalb, Illinois, United States

Site Status

Telligen

Oak Brook, Illinois, United States

Site Status

Purdue University

West Lafayette, Indiana, United States

Site Status

MetaStar

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Ross SM, Wang A, Anthony L, Persell SD, Yu J, Kho AN. Is more better? The impact of implementing more interventions for hypertension control in a practice facilitation study for small- and medium-sized practices. J Hum Hypertens. 2023 Nov;37(11):1007-1014. doi: 10.1038/s41371-023-00813-1. Epub 2023 Mar 22.

Reference Type DERIVED
PMID: 36949284 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29870868 (View on PubMed)

Other Identifiers

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HS 023921-01

Identifier Type: -

Identifier Source: org_study_id

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