HypertensionARCH DRNCT03954951
Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic
A study testing Multimodality behavioral strategy in people with Hypertension, run by Yale University at 1 site in Dominican Republic.
Trial summary
The purpose of this cluster randomized control trial is to test whether a multimodality strategy that includes an educational on-line course and performance feedback reports is effective to reduce clinical inertia in the management of hypertension in rural primary care clinics in the Dominican Republic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Multimodality behavioral strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDominican Republic
- Study dates
- 13 May 2019to 1 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care clinics in rural areas of the Peravia province with primary care physicians (general practitioners, family medicine, internists).
- Adult patients over age 18 who receive primary care at the participating clinics with history of hypertension or with blood pressure >130/80 mmHg during the visit
Who cannot join
- Pregnant patients
- Patients under age 18
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Instituto Tecnologico de Santo Domingo
Santo Domingo
About this study
Official title: Approaches to Reduce Clinical Inertia in Hypertension Management in Primary Care in the Dominican Republic
The purpose of this cluster randomized control trial is to test whether a multimodality strategy that includes an educational on-line course and performance feedback reports is effective to reduce clinical inertia in the management of hypertension in rural primary care clinics in the Dominican Republic.
Read the detailed description
Proper control of elevated blood pressure (BP) is complex due to the large number of factors associated with therapy such as patient lifestyle, therapeutic adherence and access to health care, especially in low and middle income countries. More recently another obstacle has been described; clinical inertia, defined as the failure of clinicians to initiate or intensify antihypertensive therapy despite elevated BP levels not at goal. Suboptimal therapy is the most clinically important modifiable factor known to be associated with poor BP control. Reducing clinical inertia is of significant relevance, since a proper control of hypertension can reduce mortality from coronary heart disease and mortality from cerebrovascular disease.
Our hypothesis is that a multimodality strategy that includes an on-line course on updated guidelines on hypertension management and feedback performance reports is effective to reduce clinical inertia in the management of hypertension in rural primary care clinics in the Dominican Republic.
To test this hypothesis, this study will enroll eight clinics in rural neighborhoods of the Peravia province. These are government-funded small clinics that provide primary care and preventive services and are staffed with 2-3 primary care physicians. Eight clinics will be randomized at a 1:1 ratio into a control group and and intervention group. We anticipate over 500 patients from these clinics will be included.
The primary care physicians in the intervention group will be provided with an on-line course and weekly performance feedback reports, based on the new American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology/European Society of Hypertension (ESC/ESH) hypertension guidelines. The performance feedback reports will include percent of patients with uncontrolled hypertension and among this group percent of visits where intensification in anti-hypertensive therapy was made. It will also include a comparative assessment of the performance of the physicians compared to their colleagues. The control group will continue to follow the current usual care without intervention. The total intervention and follow-up time will be 16 weeks.
- Conditions
- Hypertension
- Being tested
- Multimodality behavioral strategy
- Keywords
- hypertension, blood pressure, clinical inertia, randomized clinical trial, uncontrolled hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodality behavioral strategyOther
- On-line course on hypertension management based on the new ACC/AHA and ESC/ESH guidelines on hypertension management.
- Weekly performance feedback reports: will include percent of patients with uncontrolled hypertension and among this group percent of visits where no change in medication was made. It will also include a comparative assessment of the performance of the physicians compared with their colleagues in the province.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The clinicians in the control group will continue usual care without intervention. They will not receive the online course or performance feedback reports. |
| Intervention group | Active comparator | The primary care physicians will receive access to an online course on hypertension management based on the ACC/AHA and ESC guidelines. They will also receive feedback reports on their performance on hypertension management for 16 weeks. Receives: Other: Multimodality behavioral strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of visits with clinical inertia
Clinical inertia will be designated to visits where BP was uncontrolled (BP ≥140/90 or ≥130/80 in patients with comorbidities) where no intensification of therapy was done or no justification for deferring intensification was documented.
Measured: 16 weeks
Secondary outcomes (3)
Percentage of patients on guideline concordant hypertension management
When clinical action was taken during the visit, the appropriateness of the therapy will be evaluated according to the most recent AHA/ACC and ESC/ESH hypertension recommendations. Initial choice of antihypertensive drug therapy will be deemed appropriate if it is a thiazide diuretic, calcium channel blocker, angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB).
Measured: 16 weeks
Percentage of clinic visits with controlled blood pressure
The percentage of patients with controlled blood pressure (<140/90 and <130/80 with comorbidities) will be compared between intervention and control group/
Measured: 16 weeks
Percentage of clinic visits where counseling on lifestyle modifications was provided
Lifestyle modification counseling include: changes on diet, decrease salt intake, physical activity, alcohol intake and smoking cessation.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start13 May 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: Unable to recruit/maintain participants for intervention
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 Yale UniversityThe 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
- Parallel groups
- Model description
- Two-arm, parallel-group, cluster randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Tecnológico de Santo Domingo (INTEC)
- Responsible party
- Principal investigator, Robert McNamara, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954951
- Sponsor's protocol ID
- 2000023037
- Acronym
- ARCH DR
- Status last verified
- Feb 2020
- First submitted
- 15 May 2019
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approaches to Reduce Clinical Inertia in Hypertension Management in Primary Care in the Dominican Republic
- ClinicalTrials.gov ID
- NCT03954951
- Acronym / sponsor ID
- ARCH DR / 2000023037
- Conditions
- Hypertension
- Keywords
- hypertension, blood pressure, clinical inertia, randomized clinical trial, uncontrolled hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit/maintain participants for intervention
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Instituto Tecnológico de Santo Domingo (INTEC)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 17 May 2019 (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 purpose of this cluster randomized control trial is to test whether a multimodality strategy that includes an educational on-line course and performance feedback reports is effective to reduce clinical inertia in the management of hypertension in rural primary care clinics in the Dominican Republic.
Detailed description
Proper control of elevated blood pressure (BP) is complex due to the large number of factors associated with therapy such as patient lifestyle, therapeutic adherence and access to health care, especially in low and middle income countries. More recently another obstacle has been described; clinical inertia, defined as the failure of clinicians to initiate or intensify antihypertensive therapy despite elevated BP levels not at goal. Suboptimal therapy is the most clinically important modifiable factor known to be associated with poor BP control. Reducing clinical inertia is of significant relevance, since a proper control of hypertension can reduce mortality from coronary heart disease and mortality from cerebrovascular disease.
Our hypothesis is that a multimodality strategy that includes an on-line course on updated guidelines on hypertension management and feedback performance reports is effective to reduce clinical inertia in the management of hypertension in rural primary care clinics in the Dominican Republic.
To test this hypothesis, this study will enroll eight clinics in rural neighborhoods of the Peravia province. These are government-funded small clinics that provide primary care and preventive services and are staffed with 2-3 primary care physicians. Eight clinics will be randomized at a 1:1 ratio into a control group and and intervention group. We anticipate over 500 patients from these clinics will be included.
The primary care physicians in the intervention group will be provided with an on-line course and weekly performance feedback reports, based on the new American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology/European Society of Hypertension (ESC/ESH) hypertension guidelines. The performance feedback reports will include percent of patients with uncontrolled hypertension and among this group percent of visits where intensification in anti-hypertensive therapy was made. It will also include a comparative assessment of the performance of the physicians compared to their colleagues. The control group will continue to follow the current usual care without intervention. The total intervention and follow-up time will be 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, cluster randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The clinicians in the control group will continue usual care without intervention. They will not receive the online course or performance feedback reports. |
| Intervention group | Active comparator | Other: Multimodality behavioral strategyThe primary care physicians will receive access to an online course on hypertension management based on the ACC/AHA and ESC guidelines. They will also receive feedback reports on their performance on hypertension management for 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary care clinics in rural areas of the Peravia province with primary care physicians (general practitioners, family medicine, internists).
- Adult patients over age 18 who receive primary care at the participating clinics with history of hypertension or with blood pressure >130/80 mmHg during the visit
Key exclusion criteria (2 listed)
- Pregnant patients
- Patients under age 18
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 |
|---|---|---|
| Multimodality behavioral strategy* On-line course on hypertension management based on the new ACC/AHA and ESC/ESH guidelines on hypertension management. * Weekly performance feedback reports: will include percent of patients with uncontrolled hypertension and among this group percent of visits where no change in medication was made. It will also include a comparative assessment of the performance of the physicians compared with their colleagues in the province. | Other | Intervention group |
Primary outcome
Proportion of visits with clinical inertia
Time frame: 16 weeks
Clinical inertia will be designated to visits where BP was uncontrolled (BP ≥140/90 or ≥130/80 in patients with comorbidities) where no intensification of therapy was done or no justification for deferring intensification was documented.
3 secondary outcomes
Percentage of patients on guideline concordant hypertension management
Time frame: 16 weeks
Percentage of clinic visits with controlled blood pressure
Time frame: 16 weeks
Percentage of clinic visits where counseling on lifestyle modifications was provided
Time frame: 16 weeks
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 2 Mar 2020.
- Individual participant dataSharing planned: No
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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 Multimodality behavioral strategy in people with Hypertension, run by Yale University at 1 site in Dominican Republic.
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 2 inclusion and 2 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 2 Mar 2020. 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 Dominican Republic. 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?
Proportion of visits with clinical inertia (time frame: 16 weeks). 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 2 Mar 2020.