Healthy Hearts in the Heartland (H3)

June 3, 2019 updated by: Abel Kho, Northwestern University

Midwest Small Practice Care Transformation Research Alliance (MSPCTRA)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • DeKalb, Illinois, United States, 60115
        • Northern Illinois University (NIU)
      • Oak Brook, Illinois, United States, 60523
        • Telligen
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University
    • Wisconsin
      • Madison, Wisconsin, United States, 53713
        • MetaStar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Other: 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.
EXPERIMENTAL: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in appropriate aspirin prescribing from baseline to 12 months
Time Frame: 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.
12 months
Change in clinical performance on blood pressure control from baseline to 12 months
Time Frame: 12 months
Measured using electronic health record data. The proportion of adult (age 18-85) patients with hypertension with blood pressure <140/90
12 months
Change in clinical performance on cholesterol management from baseline to 12 months
Time Frame: 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.
12 months
Change in clinical performance on smoking cessation from baseline to 12 months
Time Frame: 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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Capacity for Quality Improvement
Time Frame: 12 months
Collected via Change Process Capability Questionnaire (CPCQ)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Chicago
Purdue University
Agency for Healthcare Research and Quality (AHRQ)
American Medical Association
Telligen, Inc.
MetaStar, Inc.
Northern Illinois University
Alliance of Chicago Community Health Services
Illinois Department of Public Health
Northwestern Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS 023921-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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