Using Practice Facilitation in Primary Care Settings to Reduce Risk Factors for Cardiovascular Disease
1 other identifier
interventional
276
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
January 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMay 20, 2019
May 1, 2019
3.7 years
December 30, 2015
May 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
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
Study Arms (4)
Cluster 1
ACTIVE COMPARATORConsists 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
ACTIVE COMPARATORConsists 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
ACTIVE COMPARATORConsists 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
ACTIVE COMPARATORConsists 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).
Interventions
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 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 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 ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Eligibility Criteria
You may qualify if:
- Eligibility includes working full or part time at the study site.
- 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).
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Related Publications (5)
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.
PMID: 33549152DERIVEDBerry 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.
PMID: 32964719DERIVEDShelley 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.
PMID: 32067871DERIVEDGepts 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.
PMID: 31711219DERIVEDShelley 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.
PMID: 27377404DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donna Shelley, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2015
First Posted
January 5, 2016
Study Start
August 1, 2015
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
May 20, 2019
Record last verified: 2019-05