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

Study Overview
=================
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.

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

Conditions
-----------------
Cardiovascular Disease, High Blood Pressure

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cluster 1<br>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<br>* 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).<br>* Other names: Chronic Care Model;Behavioral: Standard Care Regimen 9 Months<br> <br> Behavioral: Standard Care Regimen 12 Months<br> <br> Behavioral: Standard Care Regimen 15 Months<br> <br> Behavioral: Standard Care Regimen 18 Months<br> <br> Behavioral: Follow Up Post Intervention 21 Months<br> <br> Behavioral: Follow Up Post Intervention 24 Months<br> <br> |
| Active Comparator: Cluster 2<br>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<br>* 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).<br>* Other names: Chronic Care Model;Behavioral: Million Hearts ABCS 9 Months<br>* 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).<br>Behavioral: Standard Care Regimen 12 Months<br> <br> Behavioral: Standard Care Regimen 15 Months<br> <br> Behavioral: Standard Care Regimen 18 Months<br> <br> Behavioral: Standard Care Regimen 21 Months<br> <br> Behavioral: Follow Up Post Intervention 24 Months<br> <br> Behavioral: Follow Up Post Intervention 27 Months<br> <br> |
| Active Comparator: Cluster 3<br>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<br>* 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).<br>* Other names: Chronic Care Model;Behavioral: Million Hearts ABCS 9 Months<br>* 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).<br>Behavioral: Million Hearts ABCS 12 Months<br>* 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).<br>Behavioral: Standard Care Regimen 15 Months<br> <br> Behavioral: Standard Care Regimen 18 Months<br> <br> Behavioral: Standard Care Regimen 21 Months<br> <br> Behavioral: Standard Care Regimen 24 Months<br> <br> Behavioral: Follow Up Post Intervention 27 Months<br> <br> Behavioral: Follow Up Post Intervention 30 Months<br> <br> |
| Active Comparator: Cluster 4<br>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<br>* 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).<br>* Other names: Chronic Care Model;Behavioral: Million Hearts ABCS 9 Months<br>* 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).<br>Behavioral: Million Hearts ABCS 12 Months<br>* 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).<br>Behavioral: Million Hearts ABCS 15 Months<br>* 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).<br>Behavioral: Standard Care Regimen 18 Months<br> <br> Behavioral: Standard Care Regimen 21 Months<br> <br> Behavioral: Standard Care Regimen 24 Months<br> <br> Behavioral: Standard Care Regimen 27 Months<br> <br> Behavioral: Follow Up Post Intervention 30 Months<br> <br> Behavioral: Follow Up Post Intervention 33 Months<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | 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. |  | 18 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholesterol, smoking, aspirin, chronic care model