Strategies to Improve Prescribing in Heart Failure Patients

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

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

Study Overview

• Status: Terminated
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: Strategy for assisted uptitration; Other: Usual care

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20162
      • Azienda Opsedaliera Ospedale Niguarda Ca' Granda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Niguarda Hospital
• Collaborators: Associazione Nazionale Medici Cardiologi Ospedalieri; National Centre for Disease Prevention and Control
• Investigators: Study Chair: Andrea Di Lenarda, MD, Cardiovascular Center ASS 1 Triestina, Trieste Italy

Publications and helpful links

Helpful Links

• official website of the Study Sponsor Italian Association of Hospital Cardiologists

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SMART SC