Cardiovascular DiseaseNCT02646488

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

A study testing Million Hearts ABCS 6 Months, Million Hearts ABCS 9 Months and Million Hearts ABCS 12 Months in people with Cardiovascular Disease and High Blood Pressure, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Cardiovascular Disease, High Blood Pressure
What is being tested?: Million Hearts ABCS 6 Months, Million Hearts ABCS 9 Months and Million Hearts ABCS 12 Months
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 1 siteUnited States
Study dates: Aug 2015to 1 Apr 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Show all 9Show fewer

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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

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.

Conditions: Cardiovascular Disease, High Blood Pressure
Being tested: Million Hearts ABCS 6 Months, Million Hearts ABCS 9 Months, Million Hearts ABCS 12 Months, Million Hearts ABCS 15 Months, Standard Care Regimen 9 Months
Keywords: cholesterol, smoking, aspirin, chronic care model
Medical subject headings: Cardiovascular Diseases, Hypertension, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Million Hearts ABCS 6 MonthsBehavioural
Also called Chronic Care Model
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 MonthsBehavioural
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 MonthsBehavioural
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 MonthsBehavioural
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 MonthsBehavioural
Standard Care Regimen 12 MonthsBehavioural
Standard Care Regimen 15 MonthsBehavioural
Standard Care Regimen 18 MonthsBehavioural
Standard Care Regimen 21 MonthsBehavioural
Standard Care Regimen 24 MonthsBehavioural
Standard Care Regimen 27 MonthsBehavioural
Follow Up Post Intervention 21 MonthsBehavioural
Follow Up Post Intervention 24 MonthsBehavioural
Follow Up Post Intervention 27 MonthsBehavioural
Follow Up Post Intervention 30 MonthsBehavioural
Follow Up Post Intervention 33 MonthsBehavioural

Study groups in NCT02646488
Study group	Role	What they receive
Cluster 1	Active comparator	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). Receives: Behavioral: Million Hearts ABCS 6 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: Follow Up Post Intervention 21 Months; Behavioral: Follow Up Post Intervention 24 Months
Cluster 2	Active comparator	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). Receives: Behavioral: Million Hearts ABCS 6 Months; Behavioral: Million Hearts ABCS 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: Follow Up Post Intervention 24 Months; Behavioral: Follow Up Post Intervention 27 Months
Cluster 3	Active comparator	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). Receives: Behavioral: Million Hearts ABCS 6 Months; Behavioral: Million Hearts ABCS 9 Months; Behavioral: Million Hearts ABCS 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: Follow Up Post Intervention 27 Months; Behavioral: Follow Up Post Intervention 30 Months
Cluster 4	Active comparator	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). Receives: 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 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of patients with documented use of aspirin or other antithrombotic.
Measured: 18 Months
Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 20151 Apr 2019

First posted5 Jan 2016 (estimated)
Study startAug 2015
Primary completion1 Apr 2019
Study completion1 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02646488
Sponsor's protocol ID: 14-02042
Status last verified: May 2019
First submitted: 30 Dec 2015
Last updated: 20 May 2019
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 33549152
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.
PubMed 32964719
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.
PubMed 32067871
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.
PubMed 31711219
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.
PubMed 27377404

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Practice Facilitation in Primary Care Settings to Reduce Risk Factors for Cardiovascular Disease
ClinicalTrials.gov ID: NCT02646488
Acronym / sponsor ID: 14-02042
Conditions: Cardiovascular Disease, High Blood Pressure
Keywords: cholesterol, smoking, aspirin, chronic care model
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: Agency for Healthcare Research and Quality (AHRQ)
Study start: Aug 2015 (actual)
Primary completion: 1 Apr 2019 (actual)
Study completion: 1 Apr 2019 (actual)
First posted: 5 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Cluster 1	Active comparator	Behavioral: Million Hearts ABCS 6 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: Follow Up Post Intervention 21 Months, Behavioral: Follow Up Post Intervention 24 MonthsConsists 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 comparator	Behavioral: Million Hearts ABCS 6 Months, Behavioral: Million Hearts ABCS 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: Follow Up Post Intervention 24 Months, Behavioral: Follow Up Post Intervention 27 MonthsConsists 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 comparator	Behavioral: Million Hearts ABCS 6 Months, Behavioral: Million Hearts ABCS 9 Months, Behavioral: Million Hearts ABCS 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: Follow Up Post Intervention 27 Months, Behavioral: Follow Up Post Intervention 30 MonthsConsists 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 comparator	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 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 MonthsConsists 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).

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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).
at least one of the ABCS risk factors for CVD (i.e., hypertension, hyperlipidemia, eligible for aspirin and/or is a current smoker)

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Million Hearts ABCS 6 MonthsAlso: Chronic Care ModelThe ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).	Behavioural	Cluster 1, Cluster 2, Cluster 3, Cluster 4
Million Hearts ABCS 9 MonthsThe ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).	Behavioural	Cluster 2, Cluster 3, Cluster 4
Million Hearts ABCS 12 MonthsThe ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).	Behavioural	Cluster 3, Cluster 4
Million Hearts ABCS 15 MonthsThe ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).	Behavioural	Cluster 4
Standard Care Regimen 9 Months	Behavioural	Cluster 1
Standard Care Regimen 12 Months	Behavioural	Cluster 1, Cluster 2
Standard Care Regimen 15 Months	Behavioural	Cluster 1, Cluster 2, Cluster 3
Standard Care Regimen 18 Months	Behavioural	Cluster 1, Cluster 2, Cluster 3, Cluster 4
Standard Care Regimen 21 Months	Behavioural	Cluster 2, Cluster 3, Cluster 4
Standard Care Regimen 24 Months	Behavioural	Cluster 3, Cluster 4
Standard Care Regimen 27 Months	Behavioural	Cluster 4
Follow Up Post Intervention 21 Months	Behavioural	Cluster 1
Follow Up Post Intervention 24 Months	Behavioural	Cluster 1, Cluster 2
Follow Up Post Intervention 27 Months	Behavioural	Cluster 2, Cluster 3
Follow Up Post Intervention 30 Months	Behavioural	Cluster 3, Cluster 4
Follow Up Post Intervention 33 Months	Behavioural	Cluster 4

Primary outcome

Percentage of patients with documented use of aspirin or other antithrombotic.
Time frame: 18 Months
Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 24 Months

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Derived from this study: PubMed 33549152Gold 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.
Derived from this study: PubMed 32964719Berry 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.
Derived from this study: PubMed 32067871Shelley 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.
Derived from this study: PubMed 31711219Gepts 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.
Derived from this study: PubMed 27377404Shelley 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donna Shelley, MD principal investigator

New York University Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with documented use of aspirin or other antithrombotic. (time frame: 18 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02646488, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.