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OpenTrials
Completed

NCT Number: NCT02646488

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Million Hearts ABCS 6 Months

Behavioral

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

Million Hearts ABCS 9 Months

Behavioral

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).

Million Hearts ABCS 12 Months

Behavioral

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).

Million Hearts ABCS 15 Months

Behavioral

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).

Standard Care Regimen 9 Months

Behavioral

Standard Care Regimen 12 Months

Behavioral

Standard Care Regimen 15 Months

Behavioral

Standard Care Regimen 18 Months

Behavioral

Standard Care Regimen 21 Months

Behavioral

Standard Care Regimen 24 Months

Behavioral

Standard Care Regimen 27 Months

Behavioral

Follow Up Post Intervention 21 Months

Behavioral

Follow Up Post Intervention 24 Months

Behavioral

Follow Up Post Intervention 27 Months

Behavioral

Follow Up Post Intervention 30 Months

Behavioral

Follow Up Post Intervention 33 Months

Behavioral

Primary outcomes

  1. Percentage of patients with documented use of aspirin or other antithrombotic.

    Time frame: 18 Months

  2. Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled

    Time frame: 18 Months

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2016
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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