Clinical trial NCT03954951: Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic
Official title: Approaches to Reduce Clinical Inertia in Hypertension Management in Primary Care in the Dominican Republic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: hypertension
blood pressure
clinical inertia
randomized clinical trial
uncontrolled hypertension
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Instituto Tecnológico de Santo Domingo (INTEC)
First posted: 2019-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel-group, cluster randomized clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of visits with clinical inertia
timeFrame: 16 weeks
Secondary outcomes:
measure: Percentage of patients on guideline concordant hypertension management
timeFrame: 16 weeks
measure: Percentage of clinic visits with controlled blood pressure
timeFrame: 16 weeks
measure: Percentage of clinic visits where counseling on lifestyle modifications was provided
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Instituto Tecnologico de Santo Domingo
Study officials:
References: