Strategies to Improve Prescribing in Heart Failure Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-04-30

Brief Summary

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The purpose of the study is to assess whether primary care physicians may uptitrate recommended drug therapies in stable heart failure patients if educational material and specialist support including phone or mail consultation are provided

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Detailed Description

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Heart failure is highly prevalent, particularly in elderly subjects, and costly, mainly because of the high rate of recurrent hospital admissions. Although guideline-recommended treatments, such as beta-blockers and renin-angiotensin inhibitors, are effective on both mortality and morbidity, these drugs are very often underprescribed or used at lower doses than those shown to be beneficial in clinical trials, particularly in the primary care setting, for fear of adverse events. Although referral to specialist services may improve prescription of recommended drugs and doses achieved, frequent consultations may be unfeasible and costly.The study is designed to assess whether active specialist support and educational material improve the prescription process for heart failure patients in primary care

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Assisted uptitration

Uptitration of recommended drugs by primary care physician with specialist support

Group Type EXPERIMENTAL

Strategy for assisted uptitration

Intervention Type OTHER

Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration

Usual care

Usual communication strategy from cardiologist to primary care physician

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided

Interventions

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Strategy for assisted uptitration

Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration

Intervention Type OTHER

Usual care

Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* a confirmed diagnosis of heart failure wih depressed systolic function (left ventricular ejection fraction \<40% in the previous 6 months).
* stable NYHA class II-III
* a clinical indication to implement drug therapy with betablockers and/or renin-angiotensin system inhibitors and current dose \<50% of the target dose

Exclusion Criteria

* NYHA class IV or clinically unstable
* cardiac surgery or cardiac resynchronization therapy planned within the following 6 months
* discharged to a rehabilitation unit refusal or impossibility to present to outpatient visits

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No