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

Not Applicable

Completed

• Conditions: Cardiovascular Disease; High Blood Pressure
• Interventions: Behavioral: Million Hearts ABCS 6 Months; Behavioral: Standard Care Regimen 9 Months; Behavioral: Million Hearts ABCS 9 Months; Behavioral: Standard Care Regimen 12 Months; Behavioral: Million Hearts ABCS 12 Months; Behavioral: Standard Care Regimen 15 Months; Behavioral: Million Hearts ABCS 15 Months; Behavioral: Standard Care Regimen 18 Months; Behavioral: Standard Care Regimen 21 Months; Behavioral: Follow Up Post Intervention 21 Months; Behavioral: Follow Up Post Intervention 24 Months; Behavioral: Standard Care Regimen 24 Months; Behavioral: Follow Up Post Intervention 27 Months; Behavioral: Standard Care Regimen 27 Months; Behavioral: Follow Up Post Intervention 30 Months; Behavioral: Follow Up Post Intervention 33 Months

• Registration Number: NCT02646488
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cluster 2	Standard Care Regimen 21 Months	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).
Cluster 1	Follow Up Post Intervention 21 Months	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).
Cluster 1	Standard Care Regimen 12 Months	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).
Cluster 1	Standard Care Regimen 9 Months	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).
Cluster 1	Follow Up Post Intervention 24 Months	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).
Cluster 1	Standard Care Regimen 18 Months	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).
Cluster 2	Standard Care Regimen 12 Months	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).
Cluster 3	Standard Care Regimen 15 Months	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).
Cluster 4	Million Hearts ABCS 9 Months	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).
Cluster 2	Follow Up Post Intervention 27 Months	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).
Cluster 4	Standard Care Regimen 27 Months	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).
Cluster 1	Million Hearts ABCS 6 Months	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).
Cluster 1	Standard Care Regimen 15 Months	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).
Cluster 2	Standard Care Regimen 15 Months	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).
Cluster 2	Standard Care Regimen 18 Months	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).
Cluster 2	Follow Up Post Intervention 24 Months	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).
Cluster 3	Standard Care Regimen 18 Months	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).
Cluster 3	Standard Care Regimen 21 Months	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).
Cluster 3	Standard Care Regimen 24 Months	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).
Cluster 4	Follow Up Post Intervention 30 Months	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).
Cluster 2	Million Hearts ABCS 6 Months	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).
Cluster 2	Million Hearts ABCS 9 Months	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).
Cluster 4	Million Hearts ABCS 12 Months	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).
Cluster 4	Standard Care Regimen 18 Months	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).
Cluster 4	Standard Care Regimen 24 Months	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).
Cluster 3	Million Hearts ABCS 6 Months	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).
Cluster 3	Million Hearts ABCS 9 Months	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).
Cluster 4	Million Hearts ABCS 6 Months	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).
Cluster 3	Million Hearts ABCS 12 Months	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).
Cluster 3	Follow Up Post Intervention 27 Months	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).
Cluster 3	Follow Up Post Intervention 30 Months	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).
Cluster 4	Million Hearts ABCS 15 Months	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).
Cluster 4	Standard Care Regimen 21 Months	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).
Cluster 4	Follow Up Post Intervention 33 Months	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).

Primary Outcome Measures

Name	Time	Method
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
Percentage of patients with documented use of aspirin or other antithrombotic.	18 Months
Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled	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	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.	24 Months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States