Clinical trial NCT02646488: Using Practice Facilitation in Primary Care Settings to Reduce Risk Factors for Cardiovascular Disease
Official title: Using Practice Facilitation in Primary Care Settings to Reduce Risk Factors for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
High Blood Pressure
Keywords: cholesterol
smoking
aspirin
chronic care model
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2016-01-05
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: Percentage of patients with documented use of aspirin or other antithrombotic.
timeFrame: 18 Months
measure: Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled
timeFrame: 18 Months
measure: 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
timeFrame: 18 Months
measure: 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.
timeFrame: 18 Months
measure: 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.
timeFrame: 24 Months
Secondary outcomes:
measure: Percentage of patients aged 18 through 85 years of age who had a diagnosis of hypertension (HTN) who are prescribed recommended medications, if indicated.
timeFrame: 18 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Donna Shelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.