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Clinical Trials/NCT01476566
NCT01476566WithdrawnNot Applicable

Can Diagnostics and Pharmacological Prescriptions in Patients With Heart Failure be Improved? A Cluster Randomised Educational Intervention in General Practice. A Study Protocol.

University of Oslo0 sitesStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Whether drug-treatment of heart failure will be more adherent to guidelines after an educational intervention towards general practitioners (GPs).

Study Overview

Brief Summary

This study will explore the possible effect of a tailored educational intervention towards general practitioners in Norway, in order to improve the quality of treatment for heart failure in general practice.

Detailed Description

Chronic heart failure (HF) is a syndrome with a poor prognosis and with a prevalence increasing steeply by patients' age. Studies indicate that there are large potentials for improving general practitioners' diagnosis and management of HF. We have designed an educational intervention aiming at improving GPs' diagnosis and management of HF.

Peer continuous medical education (CME) groups in general practice will be recruited to a cluster randomised educational intervention study. Participating groups will be randomised either to an intervention- or a control group. A multifaceted intervention has been tailored where key components are educational outreach visits (EOV) to the CME-groups, audit, and feedback. Trained GPs will conduct the EOVs during which evidence-based recommendations for diagnosis and treatment of HF will be presented. A software will be handed out for installation on participants' practice computers, enabling collection of diagnosis- and prescription-data. The captured data will subsequently be linked to corresponding data from the Norwegian Prescription Database (NorPD). Individual feedback reports will be sent each participant in the beginning and at the end of the study. Main outcomes measure is the proportion of HF patients prescribed an ACE-inhibitor (or an angiotensine receptor blocker) and a betablocker in combination. Baseline data will provide material for a descriptive, cross sectional study. Patient related outcomes in terms of HF-hospital admissions and all cause mortality will be obtained by record linkage with NorPD and the Norwegian Patient Registry. Included in the intervention group is also a sub-study using a pop-up programme to facilitate disclosure of non-diagnosed HF patients in own practice. Finally, we plan a questionnaire study (among GPs in intervention group and their HF-patients) to get more knowledge regarding diagnostic workup, quality of care, non-pharmacological issues, and chronic care management of HF.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • General practitioner
  • Specialist in general practice

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Whether drug-treatment of heart failure will be more adherent to guidelines after an educational intervention towards general practitioners (GPs).

Time Frame: 1 year

The proportion of heart failure-patients receiving treatment with an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin-2 receptor blocker (ARB) and a beta-blocker (BB) before and after an educatopnal intervention.

Secondary Outcomes

  • Hospital admissions and mortality(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Arne Fetveit

associate professor

University of Oslo

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