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

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ClinicalTrials.gov Identifier: NCT01476566
Recruitment Status : Unknown
Verified November 2011 by Arne Fetveit, University of Oslo.
Recruitment status was:  Not yet recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Arne Fetveit, University of Oslo

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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Educational intervention Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Hospital admissions and mortality [ Time Frame: 1 year ]
    Differences in heart failure-related hospital admissions and all cause mortality between intervention group and control group.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General practitioner
  • Specialist in general practice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Arne Fetveit, associate professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01476566     History of Changes
Other Study ID Numbers: KTV-3
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Arne Fetveit, University of Oslo:
aged
family practice

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases