HypertensionNCT05413252
Team-based Care to Improve Hypertension
A study testing Practice Facilitation in people with Hypertension and Cardiovascular Diseases, run by New York University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cardiovascular Diseases
- What is being tested?
- Practice Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York University
New York, New York, 10003
New York University School of Global Public Health
New York, New York, 10012
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Cardiovascular Diseases
- Being tested
- Practice Facilitation
- Keywords
- team-based care, practice facilitation, implementation
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice FacilitationOther
Also called team-based care implementation
Practices will be assigned a practice facilitator who will support practices in implementing all practice redesign components associated with TBC for HTN management.
| Study group | Role | What they receive |
|---|---|---|
| Current Practice | No intervention | Practices will deliver care as usual and patients at these sites receive standard HTN care delivered. |
| Practice Facilitation | Active comparator | 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. Receives: Other: Practice Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start31 Jan 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- New York City Department of Health and Mental Hygiene
- Responsible party
- Sponsor
- Investigators
- Donna Shelley, MD, Principal investigator, NYU School of Global Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413252
- Sponsor's protocol ID
- IRB-FY2022-6555
- Status last verified
- Jul 2024
- First submitted
- 3 Jun 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shelley DR, Brown D, Cleland CM, Pham-Singer H, Zein D, Chang JE, Wu WY. Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial. BMC Health Serv Res. 2023 May 31;23(1):560. doi: 10.1186/s12913-023-09533-1.
PubMed 37259081McNeill E, Zein D, Chang J, Pal A, Lai AY, Fana E, White JM, Somwaru-Contreras S, Muqaddam M, Shelley D. Characterizing the practice facilitation approach: what facilitators do and how they do it to support quality improvement. Implement Sci. 2026 Jul 17. doi: 10.1186/s13012-026-01529-9. Online ahead of print.
PubMed 42469806
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitation of Team-based Care to Improve HTN Management and Outcomes
- ClinicalTrials.gov ID
- NCT05413252
- Acronym / sponsor ID
- IRB-FY2022-6555
- Conditions
- Hypertension, Cardiovascular Diseases
- Keywords
- team-based care, practice facilitation, implementation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- New York City Department of Health and Mental Hygiene
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jun 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is conducting a stepped-wedge design RCT trial. Practices will be randomized into the study into one of three waves.
| Arm | Type | Receives |
|---|---|---|
| Current Practice | No intervention | –Practices will deliver care as usual and patients at these sites receive standard HTN care delivered. |
| Practice Facilitation | Active comparator | Other: Practice FacilitationPractices 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Practice FacilitationAlso: team-based care implementationPractices will be assigned a practice facilitator who will support practices in implementing all practice redesign components associated with TBC for HTN management. | Other | Practice Facilitation |
Primary outcome
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.
1 secondary outcome
Percentage of with a diagnosis of hypertension who have a BP <140/90 (JNC Guidelines) as assessed through EHRs reports.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Results publication: PubMed 37259081Shelley DR, Brown D, Cleland CM, Pham-Singer H, Zein D, Chang JE, Wu WY. Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial. BMC Health Serv Res. 2023 May 31;23(1):560. doi: 10.1186/s12913-023-09533-1.
- Derived from this study: PubMed 42469806McNeill E, Zein D, Chang J, Pal A, Lai AY, Fana E, White JM, Somwaru-Contreras S, Muqaddam M, Shelley D. Characterizing the practice facilitation approach: what facilitators do and how they do it to support quality improvement. Implement Sci. 2026 Jul 17. doi: 10.1186/s13012-026-01529-9. Online ahead of print.
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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
NYU School of Global Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Facilitation in people with Hypertension and Cardiovascular Diseases, run by New York University at 2 sites in United States.
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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
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). 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 NCT05413252, which also lists 2 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 5 Jul 2024.