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Sponsor study identifier
interventional
276
1 country
1
Study Start
August 2015
Actual (reported)Primary Completion
April 1, 2019
Actual (reported)Study Completion
April 1, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2015
Actual (reported)December 30, 2015
Actual (reported)January 5, 2016
Actual (reported)April 1, 2019
Actual (reported)April 1, 2019
Actual (reported)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 aged 18 through 85 years of age who had a diagnosis of hypertension (HTN) who are prescribed recommended medications, if indicated.
18 Months
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).
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).
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).
New York University School of Medicine
New York, New York, 10016, United States
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.
Donna Shelley, MD
New York University Medical School
276 participants (actual enrollment reported by the registry).
First Submitted
December 30, 2015
First Posted
January 5, 2016
Study Start
August 2015
Actual (reported)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
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).
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).
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
April 1, 2019
Actual (reported)Study Completion
April 1, 2019
Actual (reported)Last Updated
May 20, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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