Team-based Care to Improve Hypertension

July 2, 2024 updated by: New York University

Facilitation of Team-based Care to Improve HTN Management and Outcomes

The study is a stepped-wedge cluster randomized control trial to compare the effect of Practice Facilitation in 90 small-to-medium sized independent primary care practices on the adoption of team-based care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is designed to transform health care delivery by helping smaller independent practices to adopt team-based care. The study will use a stepped-wedge cluster randomized control trial to compare the effect of Practice Facilitation in small-to-medium sized independent primary care practices on the adoption of team-based care aimed at improving hypertension management and blood pressure control. The study will recruit approximately 90 practices which receive practice facilitation to support the adoption of team-based care. Sites are then randomly assigned to one of three waves in which they cross over to the intervention phase. Waves are separated by 6 months and the intervention period lasts 12 months. This is followed by a phase in which sustainability of TBC and BP control is assessed. Each practice will be assigned a practice facilitator and will be required to identify a site champion who will be a member of the team. PF activities will support practices in implementing all practice redesign components associated with TBC for HTN management through training, coaching, modeling TBC, and making changes to systems where necessary to support TBC. Data collection for the primary outcome (adoption of TBC) occurs immediately prior to the beginning of the next 6-month wave. BP outcome data is collected over the 6-month period prior to the next wave. Outcomes will be measured every 6 months in all clusters at every time period so that each cluster provides data points in both the control and intervention conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dominique Brown, MPH
  • Phone Number: 23729 212 992-3729
  • Email: db3613@nyu.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University
      • New York, New York, United States, 10012
        • New York University School of Global Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • One to 5 healthcare providers
  • Minimum of 2 non-physician staff available at any time
  • Use an electronic health record (EHR) system to deliver care
  • Have no plans to participate in another CVD-related quality improvement initiative during the study
  • Willing to identify a "physician champion" or staff member to collaborate on all aspects of the intervention
  • Have a minimum of 200 patients on their practice panels that have hypertension that are managed by the practice
  • Agree to study terms including randomization, data sharing, participation in PF, and completion of surveys

Exclusion Criteria:

  • Five or more healthcare providers
  • Do not have sufficient non-physician staff on board to adopt team-based care
  • Do not use an electronic health record (EHR) system to deliver care
  • Participation or planned participation in another CVD-related improvement initiative during the time of the study
  • Unwilling to identify a "physician champion" or staff member to collaborate on all aspects of the intervention
  • Less than 200 patients on their practice panel that have hypertension that are managed by the practice.
  • Failure to agree to study terms including randomization, data sharing, participation in PF, and completion of surveys
  • Primary care practices which are unable to provide patient level BP data for 6 months prior to enrolling into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Current Practice
Practices will deliver care as usual and patients at these sites receive standard HTN care delivered.
Active Comparator: Practice Facilitation
Practices review coaching and support from a trained practice facilitator. This includes 24 site visits in which facilitators meet with staff to work on implementing system changes to improve hypertension management.
Other: Practice Facilitation
Practices will be assigned a practice facilitator who will support practices in implementing all practice redesign components associated with TBC for HTN management.
Other Names:
  • team-based care implementation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of practices that adopt team-based care as assessed by the Primary Care Team Dynamic Survey and Team Process - Monitoring Progress Toward Goals sub-scale.
Time Frame: 12 months
Five core constructs of team-based care will be measured (clear roles, communication, mutual support, measurable processes and outcomes, and shared goals) by Primary Care Team Dynamic Survey and Team Process - Monitoring Progress Toward Goals sub-scale.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of with a diagnosis of hypertension who have a BP <140/90 (JNC Guidelines) as assessed through EHRs reports.
Time Frame: 12 months
Percentage of patients 18 - 85 years of age who had a diagnosis of hypertension prior to and overlapping the measurement period and whose most recent blood pressure was adequately controlled (< 140/90 mmHg) during the measurement period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New York City Department of Health and Mental Hygiene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donna Shelley, MD, NYU School of Global Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-FY2022-6555

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Practice Facilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings