Using Practice Facilitation in Primary Care Settings to Reduce Risk Factors for Cardiovascular Disease
NCT ID: NCT02646488
Last Updated: 2019-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
276 participants
INTERVENTIONAL
2015-08-31
2019-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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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).
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).
Standard Care Regimen 9 Months
Standard Care Regimen 12 Months
Standard Care Regimen 15 Months
Standard Care Regimen 18 Months
Follow Up Post Intervention 21 Months
Follow Up Post Intervention 24 Months
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).
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).
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).
Standard Care Regimen 12 Months
Standard Care Regimen 15 Months
Standard Care Regimen 18 Months
Standard Care Regimen 21 Months
Follow Up Post Intervention 24 Months
Follow Up Post Intervention 27 Months
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).
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).
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).
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).
Standard Care Regimen 15 Months
Standard Care Regimen 18 Months
Standard Care Regimen 21 Months
Standard Care Regimen 24 Months
Follow Up Post Intervention 27 Months
Follow Up Post Intervention 30 Months
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).
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).
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).
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).
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).
Standard Care Regimen 18 Months
Standard Care Regimen 21 Months
Standard Care Regimen 24 Months
Standard Care Regimen 27 Months
Follow Up Post Intervention 30 Months
Follow Up Post Intervention 33 Months
Interventions
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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).
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).
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).
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).
Standard Care Regimen 9 Months
Standard Care Regimen 12 Months
Standard Care Regimen 15 Months
Standard Care Regimen 18 Months
Standard Care Regimen 21 Months
Standard Care Regimen 24 Months
Standard Care Regimen 27 Months
Follow Up Post Intervention 21 Months
Follow Up Post Intervention 24 Months
Follow Up Post Intervention 27 Months
Follow Up Post Intervention 30 Months
Follow Up Post Intervention 33 Months
Other Intervention Names
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Eligibility Criteria
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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).
* 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)
18 Years
85 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Donna Shelley, MD
Role: PRINCIPAL_INVESTIGATOR
New York University Medical School
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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References
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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.
Other Identifiers
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14-02042
Identifier Type: -
Identifier Source: org_study_id
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