Can Diagnostics and Pharmacological Prescriptions in Patients With Heart Failure be Improved in General Practice?

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2011 by University of Oslo
Sponsor:
Information provided by (Responsible Party):
Arne Fetveit, University of Oslo
ClinicalTrials.gov Identifier:
NCT01476566
First received: November 14, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Heart Failure
Behavioral: Educational intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Can Diagnostics and Pharmacological Prescriptions in Patients With Heart Failure be Improved? A Cluster Randomised Educational Intervention in General Practice. A Study Protocol.

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Whether drug-treatment of heart failure will be more adherent to guidelines after an educational intervention towards general practitioners (GPs). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Hospital admissions and mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Differences in heart failure-related hospital admissions and all cause mortality between intervention group and control group.


Estimated Enrollment: 1940
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational intervention
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.
Behavioral: Educational intervention
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).
No Intervention: Control group

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General practitioner
  • Specialist in general practice
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476566

Contacts
Contact: Jørund Straand, MD PhD jorund.straand@medisin.uio.no
Contact: Arne Fetveit, MD PhD arne.fetveit@medisin.uio.no

Sponsors and Collaborators
University of Oslo
  More Information

No publications provided

Responsible Party: Arne Fetveit, associate professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01476566     History of Changes
Other Study ID Numbers: KTV-3
Study First Received: November 14, 2011
Last Updated: November 17, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University of Oslo:
aged
family practice

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014