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

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02646488

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

276

Enrollment

Location

Arms

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease High Blood Pressure	Behavioral: Million Hearts ABCS 6 Months Behavioral: Million Hearts ABCS 9 Months Behavioral: Million Hearts ABCS 12 Months Behavioral: Million Hearts ABCS 15 Months 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: 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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

276 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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: 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 12 Months Behavioral: Standard Care Regimen 15 Months Behavioral: Standard Care Regimen 18 Months Behavioral: Standard Care Regimen 21 Months Behavioral: Follow Up Post Intervention 24 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: 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: 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 15 Months Behavioral: Standard Care Regimen 18 Months Behavioral: Standard Care Regimen 21 Months Behavioral: Standard Care Regimen 24 Months Behavioral: Follow Up Post Intervention 27 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: 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: 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: 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 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 30 Months Behavioral: Follow Up Post Intervention 33 Months

Outcome Measures

Primary Outcome Measures

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]
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 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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)