Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic (ARCH DR)

Approaches to Reduce Clinical Inertia in Hypertension Management in Primary Care in the Dominican Republic

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension
• Intervention / Treatment: Other: Multimodality behavioral strategy

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Instituto Tecnologico de Santo Domingo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of visits with clinical inertia	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.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients on guideline concordant hypertension management	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).	16 weeks
Percentage of clinic visits with controlled blood pressure	The percentage of patients with controlled blood pressure (<140/90 and <130/80 with comorbidities) will be compared between intervention and control group/	16 weeks
Percentage of clinic visits where counseling on lifestyle modifications was provided	Lifestyle modification counseling include: changes on diet, decrease salt intake, physical activity, alcohol intake and smoking cessation.	16 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Instituto Tecnológico de Santo Domingo (INTEC)

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: hypertension; blood pressure; randomized clinical trial; uncontrolled hypertension; clinical inertia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2000023037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No