ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02646488
Recruitment Status : Active, not recruiting
First Posted : January 5, 2016
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease High Blood Pressure Behavioral: Million Hearts ABCS 6 Months Behavioral: Million Hearts ABCS 9 Months Behavioral: Million Hearts ABCS 12 Months Behavioral: Million Hearts ABCS 15 Months Behavioral: Standard Care Regimen 9 Months Behavioral: Standard Care Regimen 12 Months Behavioral: Standard Care Regimen 15 Months Behavioral: Standard Care Regimen 18 Months Behavioral: Standard Care Regimen 21 Months Behavioral: Standard Care Regimen 24 Months Behavioral: Standard Care Regimen 27 Months Behavioral: Follow Up Post Intervention 21 Months Behavioral: Follow Up Post Intervention 24 Months Behavioral: Follow Up Post Intervention 27 Months Behavioral: Follow Up Post Intervention 30 Months Behavioral: Follow Up Post Intervention 33 Months Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Using Practice Facilitation in Primary Care Settings to Reduce Risk Factors for Cardiovascular Disease
Actual Study Start Date : August 2015
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).
Behavioral: 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).
Other Name: Chronic Care Model

Behavioral: Standard Care Regimen 9 Months
Behavioral: Standard Care Regimen 12 Months
Behavioral: Standard Care Regimen 15 Months
Behavioral: Standard Care Regimen 18 Months
Behavioral: Follow Up Post Intervention 21 Months
Behavioral: Follow Up Post Intervention 24 Months
Active Comparator: 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).
Behavioral: 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).
Other Name: Chronic Care Model

Behavioral: 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).

Behavioral: Standard Care Regimen 12 Months
Behavioral: Standard Care Regimen 15 Months
Behavioral: Standard Care Regimen 18 Months
Behavioral: Standard Care Regimen 21 Months
Behavioral: Follow Up Post Intervention 24 Months
Behavioral: Follow Up Post Intervention 27 Months
Active Comparator: 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).
Behavioral: 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).
Other Name: Chronic Care Model

Behavioral: 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).

Behavioral: 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).

Behavioral: Standard Care Regimen 15 Months
Behavioral: Standard Care Regimen 18 Months
Behavioral: Standard Care Regimen 21 Months
Behavioral: Standard Care Regimen 24 Months
Behavioral: Follow Up Post Intervention 27 Months
Behavioral: Follow Up Post Intervention 30 Months
Active Comparator: 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).
Behavioral: 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).
Other Name: Chronic Care Model

Behavioral: 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).

Behavioral: 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).

Behavioral: 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).

Behavioral: Standard Care Regimen 18 Months
Behavioral: Standard Care Regimen 21 Months
Behavioral: Standard Care Regimen 24 Months
Behavioral: Standard Care Regimen 27 Months
Behavioral: Follow Up Post Intervention 30 Months
Behavioral: Follow Up Post Intervention 33 Months



Primary Outcome Measures :
  1. Percentage of patients with documented use of aspirin or other antithrombotic. [ Time Frame: 18 Months ]
  2. Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled [ Time Frame: 18 Months ]
  3. 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 [ Time Frame: 18 Months ]
  4. 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. [ Time Frame: 18 Months ]
  5. 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. [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  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. [ Time Frame: 18 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646488


Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Donna Shelley, MD New York University Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02646488     History of Changes
Other Study ID Numbers: 14-02042
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Keywords provided by New York University School of Medicine:
cholesterol
smoking
aspirin
chronic care model

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics