Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic

NCT ID: NCT03954951

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2019-09-01

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Multimodality behavioral strategy

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnant patients
• Patients under age 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Tecnológico de Santo Domingo (INTEC)

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Robert McNamara

Associate Professor of Medicine (Cardiology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Tecnologico de Santo Domingo

Santo Domingo, , Dominican Republic

Countries

Dominican Republic

Other Identifiers

2000023037

Identifier Type: -

Identifier Source: org_study_id