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

NYU Langone Health

Status: Completed

Conditions: High Blood Pressure; Cardiovascular Disease

Treatments: Behavioral: Million Hearts ABCS 9 Months; Behavioral: Standard Care Regimen 24 Months; Behavioral: Standard Care Regimen 9 Months; Behavioral: Standard Care Regimen 12 Months; Behavioral: Standard Care Regimen 15 Months; Behavioral: Million Hearts ABCS 12 Months; Behavioral: Follow Up Post Intervention 33 Months; Behavioral: Million Hearts ABCS 15 Months; Behavioral: Standard Care Regimen 18 Months; Behavioral: Follow Up Post Intervention 24 Months; Behavioral: Follow Up Post Intervention 27 Months; Behavioral: Follow Up Post Intervention 21 Months; Behavioral: Standard Care Regimen 27 Months; Behavioral: Million Hearts ABCS 6 Months; Behavioral: Follow Up Post Intervention 30 Months; Behavioral: Standard Care Regimen 21 Months

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02646488

14-02042

Details and patient eligibility

About

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.

Enrollment: 276 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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276 participants in 4 patient groups

Cluster 1

Active Comparator group

Description:

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).

Treatment:

Behavioral: Million Hearts ABCS 6 Months

Behavioral: Follow Up Post Intervention 21 Months

Behavioral: Standard Care Regimen 9 Months

Behavioral: Standard Care Regimen 12 Months

Behavioral: Follow Up Post Intervention 24 Months

Behavioral: Standard Care Regimen 18 Months

Behavioral: Standard Care Regimen 15 Months

Cluster 2

Active Comparator group

Description:

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).

Treatment:

Behavioral: Million Hearts ABCS 6 Months

Behavioral: Million Hearts ABCS 9 Months

Behavioral: Standard Care Regimen 21 Months

Behavioral: Standard Care Regimen 12 Months

Behavioral: Follow Up Post Intervention 27 Months

Behavioral: Follow Up Post Intervention 24 Months

Behavioral: Standard Care Regimen 18 Months

Behavioral: Standard Care Regimen 15 Months

Cluster 3

Active Comparator group

Description:

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).

Treatment:

Behavioral: Million Hearts ABCS 6 Months

Behavioral: Million Hearts ABCS 9 Months

Behavioral: Standard Care Regimen 21 Months

Behavioral: Standard Care Regimen 24 Months

Behavioral: Million Hearts ABCS 12 Months

Behavioral: Follow Up Post Intervention 27 Months

Behavioral: Standard Care Regimen 18 Months

Behavioral: Follow Up Post Intervention 30 Months

Behavioral: Standard Care Regimen 15 Months

Cluster 4

Active Comparator group

Description:

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).

Treatment:

Behavioral: Million Hearts ABCS 6 Months

Behavioral: Million Hearts ABCS 9 Months

Behavioral: Standard Care Regimen 21 Months

Behavioral: Standard Care Regimen 24 Months

Behavioral: Follow Up Post Intervention 33 Months

Behavioral: Million Hearts ABCS 12 Months

Behavioral: Standard Care Regimen 18 Months

Behavioral: Follow Up Post Intervention 30 Months

Behavioral: Standard Care Regimen 27 Months

Behavioral: Million Hearts ABCS 15 Months