Strategies to Improve Prescribing in Heart Failure Patients

Study Overview
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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

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

Official Title
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Strategies To Improve Appropriate Prescribing In Heart Failure Patients. Assessment of the Effectiveness of an Integrated Clinical Pathway Between Cardiology and Primary Care Physicians to Implement Pharmacological Treatment

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Other: Strategy for assisted uptitration
* Other: Usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assisted uptitration<br>Uptitration of recommended drugs by primary care physician with specialist support | Other: Strategy for assisted uptitration<br>* Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration<br>|
| Active Comparator: Usual care<br>Usual communication strategy from cardiologist to primary care physician | Other: Usual care<br>* Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers |  | 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 |  | 12 weeks | 
| all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire |  | 12 weeks | 
| value of DRG reimbursement for hospital admissions and specialist visits |  | 12 weeks |