Using Practice Facilitation in Primary Care Settings to Reduce Risk Factors for Cardiovascular Disease

May 17, 2019 updated by: NYU Langone Health
The primary purpose of this study is to evaluate the effectiveness of practice facilitation as a quality improvement strategy for implementing the Million Hearts' ABCS treatment guidelines for reducing cardiovascular disease (CVD) among high-risk patients who receive care in primary care practices in New York City. The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S). The long-term goal is to create a robust infrastructure to disseminate and implement evidence based practice guidelines (EBPG) findings in primary care practices and improve practices' capacity to receive and implement other EBPG findings in the future.

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.

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.
276

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
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Provider and staff eligibility inclusion criteria.

  • Eligibility includes working full or part time at the study site.

Stakeholder eligibility inclusion criteria.

  • Steering committee members or other key stakeholder from the following groups: Health Plan Chief Medical Officer, State health officials in the Chronic Disease Program, and leadership from relevant national associations (American Heart Association), members of Advisory Board of CHCANYS (these are physician leaders).

Patient eligibility inclusion criteria:

  • at least one of the ABCS risk factors for CVD (i.e., hypertension, hyperlipidemia, eligible for aspirin and/or is a current smoker)
  • must have received care at the clinic for at least 12 months
  • Patients eligible for aspirin are those with a documented ICD-9 code for ischemic vascular disease in the last 12 months. Similarly, patients with a diagnosis of hypertension and/or hyperlipidemia will have a documented ICD-9 code for the targeted risk factor
  • Smokers will be identified by a documented ICD-9 code, prescription for a cessation medication in the last 12 months or documentation in the chart (e.g. meaningful use measure) during the last 12 months (see outcome measures)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

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.
Active Comparator: Cluster 1
Consists of 80 sites chosen by block randomization in four waves every three months (80 in the first three waves and 60 in the last wave).
Behavioral: Million Hearts ABCS 6 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Other Names:
  • Chronic Care Model
Behavioral: Standard Care Regimen 9 Months
Behavioral: Standard Care Regimen 12 Months
Behavioral: Standard Care Regimen 15 Months
Behavioral: Standard Care Regimen 18 Months
Behavioral: Follow Up Post Intervention 21 Months
Behavioral: Follow Up Post Intervention 24 Months
Active Comparator: Cluster 2
Consists of 80 sites chosen by block randomization in four waves every three months (80 in the first three waves and 60 in the last wave).
Behavioral: Million Hearts ABCS 6 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Other Names:
  • Chronic Care Model
Behavioral: Standard Care Regimen 12 Months
Behavioral: Standard Care Regimen 15 Months
Behavioral: Standard Care Regimen 18 Months
Behavioral: Follow Up Post Intervention 24 Months
Behavioral: Million Hearts ABCS 9 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Behavioral: Standard Care Regimen 21 Months
Behavioral: Follow Up Post Intervention 27 Months
Active Comparator: Cluster 3
Consists of 80 sites chosen by block randomization in four waves every three months (80 in the first three waves and 60 in the last wave).
Behavioral: Million Hearts ABCS 6 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Other Names:
  • Chronic Care Model
Behavioral: Standard Care Regimen 15 Months
Behavioral: Standard Care Regimen 18 Months
Behavioral: Million Hearts ABCS 9 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Behavioral: Standard Care Regimen 21 Months
Behavioral: Follow Up Post Intervention 27 Months
Behavioral: Million Hearts ABCS 12 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Behavioral: Standard Care Regimen 24 Months
Behavioral: Follow Up Post Intervention 30 Months
Active Comparator: Cluster 4
Consists of 80 sites chosen by block randomization in four waves every three months (80 in the first three waves and 60 in the last wave).
Behavioral: Million Hearts ABCS 6 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Other Names:
  • Chronic Care Model
Behavioral: Standard Care Regimen 18 Months
Behavioral: Million Hearts ABCS 9 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Behavioral: Standard Care Regimen 21 Months
Behavioral: Million Hearts ABCS 12 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Behavioral: Standard Care Regimen 24 Months
Behavioral: Follow Up Post Intervention 30 Months
Behavioral: Million Hearts ABCS 15 Months
The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Behavioral: Standard Care Regimen 27 Months
Behavioral: Follow Up Post Intervention 33 Months

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
Time Frame
Percentage of patients with documented use of aspirin or other antithrombotic.
Time Frame: 18 Months
18 Months
Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled
Time Frame: 18 Months
18 Months
Percentage of patients who had a fasting lipoprotein (LDL) test performed and whose risk-stratified fasting LDL is at or below the recommended low density lipoprotein (LDL) goal
Time Frame: 18 Months
18 Months
Change in the percentage of patients who had a low density lipoprotein (LDL) test who are prescribed a recommended dose of statin based on risk status if indicated.
Time Frame: 18 Months
18 Months
Percentage of patients who were screened about tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user.
Time Frame: 24 Months
24 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
Time Frame
Percentage of patients aged 18 through 85 years of age who had a diagnosis of hypertension (HTN) who are prescribed recommended medications, if indicated.
Time Frame: 18 Months
18 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.
NYU Langone Health

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.
Agency for Healthcare Research and Quality (AHRQ)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donna Shelley, MD, New York University Medical School

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.
August 1, 2015

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.
April 1, 2019

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.
April 1, 2019

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).
December 30, 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.
January 4, 2016

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.
January 5, 2016

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.
May 20, 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.
May 17, 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.
May 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.
  • 14-02042

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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