Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic

Not Applicable

Withdrawn

• Conditions: Hypertension
• Interventions: Other: Multimodality behavioral strategy

• Registration Number: NCT03954951
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2019-05-13
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Multimodality behavioral strategy	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.

Primary Outcome Measures

Name	Time	Method
Proportion of visits with clinical inertia	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of clinic visits where counseling on lifestyle modifications was provided	16 weeks	Lifestyle modification counseling include: changes on diet, decrease salt intake, physical activity, alcohol intake and smoking cessation.
Percentage of patients on guideline concordant hypertension management	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	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/

Trial Locations

Locations (1)

Instituto Tecnologico de Santo Domingo; 🇩🇴 Santo Domingo, Dominican Republic