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Team-based Care to Improve Hypertension

Primary Purpose

Hypertension, Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practice Facilitation
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring team-based care, practice facilitation, implementation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • One to 4 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.

Sites / Locations

  • New York University School of Global Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Current Practice

Practice Facilitation

Arm Description

Practices will deliver care as usual and patients at these sites receive standard HTN care delivered.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage of with a diagnosis of hypertension who have a BP <140/90 (JNC Guidelines) as assessed through EHRs reports.
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.

Full Information

First Posted
June 3, 2022
Last Updated
April 28, 2023
Sponsor
New York University
Collaborators
New York City Department of Health and Mental Hygiene
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1. Study Identification

Unique Protocol Identification Number
NCT05413252
Brief Title
Team-based Care to Improve Hypertension
Official Title
Facilitation of Team-based Care to Improve HTN Management and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
New York City Department of Health and Mental Hygiene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Diseases
Keywords
team-based care, practice facilitation, implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The study is conducting a stepped-wedge design RCT trial. Practices will be randomized into the study into one of three waves.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current Practice
Arm Type
No Intervention
Arm Description
Practices will deliver care as usual and patients at these sites receive standard HTN care delivered.
Arm Title
Practice Facilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Practice Facilitation
Other Intervention Name(s)
team-based care implementation
Intervention Description
Practices will be assigned a practice facilitator who will support practices in implementing all practice redesign components associated with TBC for HTN management.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of with a diagnosis of hypertension who have a BP <140/90 (JNC Guidelines) as assessed through EHRs reports.
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Shelley, MD
Organizational Affiliation
NYU School of Global Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Global Public Health
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Team-based Care to Improve Hypertension

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