Strategies to Improve Prescribing in Heart Failure Patients

Niguarda Hospital30 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Chronic Heart Failure

Interventions

Strategy for assisted uptitrationOTHER

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

Usual careOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Azienda Opsedaliera Ospedale Niguarda Ca' Granda

Milan, MI, Italy

Outcomes

Primary Outcomes

achievement of ≥ 50% of the target dose either for beta-blockers (12.5mg b.i.d. for carvedilol, 5mg u.i.d for bisoprolol) or for ACE-inhibitors or angiotensin-receptor blockers in patients in whom beta-blockers are contraindicated

Time frame: 12 weeks

Secondary Outcomes

achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers

Time frame: 12 weeks

proportion of patients who started drug uptitration by week 12 expressed as N° patients in whom therapy was uptitrated by their primary care physician/N° randomized patients

Time frame: 12 weeks

all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire

Time frame: 12 weeks

value of DRG reimbursement for hospital admissions and specialist visits

Time frame: 12 weeks

Data from ClinicalTrials.gov

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