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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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: Standard Care Regimen 12 Months; Behavioral: Standard Care Regimen 15 Months; Behavioral: Standard Care Regimen 18 Months; Behavioral: Follow Up Post Intervention 24 Months; 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 21 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: Standard Care Regimen 15 Months; Behavioral: Standard Care Regimen 18 Months; 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 21 Months; Behavioral: Follow Up Post Intervention 27 Months; 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 24 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: Standard Care Regimen 18 Months; 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 21 Months; 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 24 Months; Behavioral: Follow Up Post Intervention 30 Months; 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 27 Months; Behavioral: Follow Up Post Intervention 33 Months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Donna Shelley, MD, New York University Medical School

Publications and helpful links

General Publications

• Gold HT, Siman N, Cuthel AM, Nguyen AM, Pham-Singer H, Berry CA, Shelley DR. A practice facilitation-guided intervention in primary care settings to reduce cardiovascular disease risk: a cost analysis. Implement Sci Commun. 2021 Feb 6;2(1):15. doi: 10.1186/s43058-021-00116-x.
• Berry CA, Nguyen AM, Cuthel AM, Cleland CM, Siman N, Pham-Singer H, Shelley DR. Measuring Implementation Strategy Fidelity in HealthyHearts NYC: A Complex Intervention Using Practice Facilitation in Primary Care. Am J Med Qual. 2021 Jul-Aug 01;36(4):270-276. doi: 10.1177/1062860620959450.
• Shelley DR, Gepts T, Siman N, Nguyen AM, Cleland C, Cuthel AM, Rogers ES, Ogedegbe O, Pham-Singer H, Wu W, Berry CA. Cardiovascular Disease Guideline Adherence: An RCT Using Practice Facilitation. Am J Prev Med. 2020 May;58(5):683-690. doi: 10.1016/j.amepre.2019.12.013. Epub 2020 Feb 14.
• Gepts T, Nguyen AM, Cleland C, Wu W, Pham-Singer H, Shelley D. Accounting for Blood Pressure Seasonality Alters Evaluation of Practice-Level Blood Pressure Control Intervention. Am J Hypertens. 2020 Mar 13;33(3):220-222. doi: 10.1093/ajh/hpz179.
• Shelley DR, Ogedegbe G, Anane S, Wu WY, Goldfeld K, Gold HT, Kaplan S, Berry C. Testing the use of practice facilitation in a cluster randomized stepped-wedge design trial to improve adherence to cardiovascular disease prevention guidelines: HealthyHearts NYC. Implement Sci. 2016 Jul 4;11(1):88. doi: 10.1186/s13012-016-0450-2.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: smoking; aspirin; chronic care model; cholesterol
• Additional Relevant MeSH Terms: Vascular Diseases; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: 14-02042