Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-10 @ 3:29 PM
Study NCT ID:
NCT03954951
Status:
WITHDRAWN
Last Update Posted:
2020-03-02
First Post:
2019-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm, parallel-group, cluster randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to recruit/maintain participants for intervention', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2019-05-15', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of visits with clinical inertia', 'timeFrame': '16 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients on guideline concordant hypertension management', 'timeFrame': '16 weeks', 'description': '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).'}, {'measure': 'Percentage of clinic visits with controlled blood pressure', 'timeFrame': '16 weeks', 'description': 'The percentage of patients with controlled blood pressure (\\<140/90 and \\<130/80 with comorbidities) will be compared between intervention and control group/'}, {'measure': 'Percentage of clinic visits where counseling on lifestyle modifications was provided', 'timeFrame': '16 weeks', 'description': 'Lifestyle modification counseling include: changes on diet, decrease salt intake, physical activity, alcohol intake and smoking cessation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'blood pressure', 'clinical inertia', 'randomized clinical trial', 'uncontrolled hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOur 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.\n\nTo 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Clinics:\n\n* Primary care clinics in rural areas of the Peravia province with primary care physicians (general practitioners, family medicine, internists).\n\nInclusion Criteria for Patients:\n\n* 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\n\nExclusion Criteria for patients:\n\n* Pregnant patients\n* Patients under age 18'}, 'identificationModule': {'nctId': 'NCT03954951', 'acronym': 'ARCH DR', 'briefTitle': 'Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Approaches to Reduce Clinical Inertia in Hypertension Management in Primary Care in the Dominican Republic', 'orgStudyIdInfo': {'id': '2000023037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The clinicians in the control group will continue usual care without intervention. They will not receive the online course or performance feedback reports.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': '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.', 'interventionNames': ['Other: Multimodality behavioral strategy']}], 'interventions': [{'name': 'Multimodality behavioral strategy', 'type': 'OTHER', 'description': '* On-line course on hypertension management based on the new ACC/AHA and ESC/ESH guidelines on hypertension management.\n* 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.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Instituto Tecnologico de Santo Domingo', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Tecnológico de Santo Domingo (INTEC)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine (Cardiology)', 'investigatorFullName': 'Robert McNamara', 'investigatorAffiliation': 'Yale University'}}}}