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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646488
• Other study ID #: 14-02042
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: April 1, 2019

Study information

• Verified date: May 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• High Blood Pressure
• Hypertension

Intervention

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).
• 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).
• 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).
• 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).
• Standard Care Regimen 9 Months

• Standard Care Regimen 12 Months

• Standard Care Regimen 15 Months

• Standard Care Regimen 18 Months

• Standard Care Regimen 21 Months

• Standard Care Regimen 24 Months

• Standard Care Regimen 27 Months

• Follow Up Post Intervention 21 Months

• Follow Up Post Intervention 24 Months

• Follow Up Post Intervention 27 Months

• Follow Up Post Intervention 30 Months

• Follow Up Post Intervention 33 Months

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with documented use of aspirin or other antithrombotic.		18 Months
Primary	Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled		18 Months
Primary	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		18 Months
Primary	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.		18 Months
Primary	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.		24 Months
Secondary	Percentage of patients aged 18 through 85 years of age who had a diagnosis of hypertension (HTN) who are prescribed recommended medications, if indicated.		18 Months