HypertensionNCT03563872
Enhancing Systems of Care to Improve Hypertension Guideline Implementation
A study testing Intervention and Active Comparator in people with Hypertension, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Intervention and Active Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2019to Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years) African Americans
- Lacks established primary care for BP management
- History of HTN
- SBP ≥ 140 mmHg
Who cannot join
- Pregnancy
- Need for hospitalization from ED
- Serious comorbid conditions
- Alcohol or drug dependence
- Suspected resistant HTN
- Anticipated poor-adherence to study designated primary care clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Systems of Care to Improve Hypertension Guideline Implementation to Communities With Health Disparities
This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. The trial will take place within an integrated health system serving Detroit and will assess blood pressure control over one year's time.
Read the detailed description
The trial will randomize 12 clinics within the Henry Ford Health System to two arms. The first arm will be comparison clinics that continue to use existing team-based strategies for hypertension management. The second arm will be intervention clinics. These clinics will have enhancements to existing team-based hypertension management. The first enhancement is clinical decision support based in the electronic health record. The second enhancement is improved protocols to implement telehealth prescribing that is nurse-led.
The trial will enroll participants through an urban emergency department. Participants will be assigned to one of these 12 clinics and continue study activities for 1 year. Clinicians at the clinics will manage blood pressure. Study specific visits will occur at 3, 6, 9, and 12 months. Primary outcome assessment is 12 months.
- Conditions
- Hypertension
- Being tested
- Intervention, Active Comparator
- Keywords
- hypertension, team-based, guidelines, implementation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.
Active ComparatorOther
Usual, team-based care
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Team-based care Receives: Other: Active Comparator |
| Intervention | Experimental | Enhanced team-based care Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
mean change
Measured: 12 months
Secondary outcomes (4)
Therapeutic Intensity
Calculated therapeutic intensity score
Measured: 12 months
Change in systolic blood pressure
mean change
Measured: 6 months
Change in diastolic blood pressure
mean change
Measured: 12 months
Treatment Congruence
Proportion of clinical encounters in which treatment is congruent with guidelines
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 posted20 Jun 2018
- Study startFeb 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Miller, MD, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563872
- Sponsor's protocol ID
- 13455
- Status last verified
- Feb 2019
- First submitted
- 10 Jun 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Systems of Care to Improve Hypertension Guideline Implementation to Communities With Health Disparities
- ClinicalTrials.gov ID
- NCT03563872
- Acronym / sponsor ID
- 13455
- Conditions
- Hypertension
- Keywords
- hypertension, team-based, guidelines, implementation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 20 Jun 2018 (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.
This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. The trial will take place within an integrated health system serving Detroit and will assess blood pressure control over one year's time.
Detailed description
The trial will randomize 12 clinics within the Henry Ford Health System to two arms. The first arm will be comparison clinics that continue to use existing team-based strategies for hypertension management. The second arm will be intervention clinics. These clinics will have enhancements to existing team-based hypertension management. The first enhancement is clinical decision support based in the electronic health record. The second enhancement is improved protocols to implement telehealth prescribing that is nurse-led.
The trial will enroll participants through an urban emergency department. Participants will be assigned to one of these 12 clinics and continue study activities for 1 year. Clinicians at the clinics will manage blood pressure. Study specific visits will occur at 3, 6, 9, and 12 months. Primary outcome assessment is 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Other: Active ComparatorTeam-based care |
| Intervention | Experimental | Other: InterventionEnhanced team-based care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (>18 years) African Americans
- Lacks established primary care for BP management
- History of HTN
- SBP ≥ 140 mmHg
Key exclusion criteria (6 listed)
- Pregnancy
- Need for hospitalization from ED
- Serious comorbid conditions
- Alcohol or drug dependence
- Suspected resistant HTN
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 |
|---|---|---|
| InterventionEnhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing. | Other | Intervention |
| Active ComparatorUsual, team-based care | Other | Active Comparator |
Primary outcome
Change in systolic blood pressure
Time frame: 12 months
mean change
4 secondary outcomes
Therapeutic Intensity
Time frame: 12 months
Change in systolic blood pressure
Time frame: 6 months
Change in diastolic blood pressure
Time frame: 12 months
Treatment Congruence
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention and Active Comparator in people with Hypertension, run by Henry Ford Health System at 1 site 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 25 Feb 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in systolic blood pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2019.