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Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic (ARCH DR)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension | Other: Multimodality behavioral strategy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Two-arm, parallel-group, cluster randomized clinical trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Approaches to Reduce Clinical Inertia in Hypertension Management in Primary Care in the Dominican Republic |
| Actual Study Start Date : | May 13, 2019 |
| Actual Primary Completion Date : | September 1, 2019 |
| Actual Study Completion Date : | September 1, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Control group
The clinicians in the control group will continue usual care without intervention. They will not receive the online course or performance feedback reports.
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Active Comparator: Intervention group
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.
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Other: Multimodality behavioral strategy
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- 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.
- Percentage of patients on guideline concordant hypertension management [ Time Frame: 16 weeks ]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).
- Percentage of clinic visits with controlled blood pressure [ Time Frame: 16 weeks ]The percentage of patients with controlled blood pressure (<140/90 and <130/80 with comorbidities) will be compared between intervention and control group/
- Percentage of clinic visits where counseling on lifestyle modifications was provided [ Time Frame: 16 weeks ]Lifestyle modification counseling include: changes on diet, decrease salt intake, physical activity, alcohol intake and smoking cessation.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Clinics:
- Primary care clinics in rural areas of the Peravia province with primary care physicians (general practitioners, family medicine, internists).
Inclusion Criteria for Patients:
- 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
Exclusion Criteria for patients:
- Pregnant patients
- Patients under age 18
| Dominican Republic | |
| Instituto Tecnologico de Santo Domingo | |
| Santo Domingo, Dominican Republic | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 15, 2019 | ||||
| First Posted Date ICMJE | May 17, 2019 | ||||
| Last Update Posted Date | March 2, 2020 | ||||
| Actual Study Start Date ICMJE | May 13, 2019 | ||||
| Actual Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic | ||||
| Official Title ICMJE | Approaches to Reduce Clinical Inertia in Hypertension Management in Primary Care in the Dominican Republic | ||||
| Brief 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. | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Two-arm, parallel-group, cluster randomized clinical trial Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE | Other: Multimodality behavioral strategy
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE |
0 | ||||
| Original Estimated Enrollment ICMJE |
500 | ||||
| Actual Study Completion Date ICMJE | September 1, 2019 | ||||
| Actual Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria for Clinics:
Inclusion Criteria for Patients:
Exclusion Criteria for patients:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Dominican Republic | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03954951 | ||||
| Other Study ID Numbers ICMJE | 2000023037 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Robert McNamara, Yale University | ||||
| Study Sponsor ICMJE | Yale University | ||||
| Collaborators ICMJE | Instituto tecnológico de Santo Domingo | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Yale University | ||||
| Verification Date | February 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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