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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring aged, family practice

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • General practitioner
  • Specialist in general practice

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Educational intervention

    Control group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Whether drug-treatment of heart failure will be more adherent to guidelines after an educational intervention towards general practitioners (GPs).
    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
    Differences in heart failure-related hospital admissions and all cause mortality between intervention group and control group.

    Full Information

    First Posted
    November 14, 2011
    Last Updated
    November 17, 2011
    Sponsor
    University of Oslo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01476566
    Brief Title
    Can Diagnostics and Pharmacological Prescriptions in Patients With Heart Failure be Improved in General Practice?
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    January 2014 (Anticipated)
    Study Completion Date
    January 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Oslo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    aged, family practice

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1940 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Educational intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational intervention
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Whether drug-treatment of heart failure will be more adherent to guidelines after an educational intervention towards general practitioners (GPs).
    Description
    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.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Hospital admissions and mortality
    Description
    Differences in heart failure-related hospital admissions and all cause mortality between intervention group and control group.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: General practitioner Specialist in general practice
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jørund Straand, MD PhD
    Email
    jorund.straand@medisin.uio.no
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arne Fetveit, MD PhD
    Email
    arne.fetveit@medisin.uio.no

    12. IPD Sharing Statement

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

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