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
About this trial
This is an interventional health services research trial for Heart Failure focused on measuring aged, family practice
Eligibility Criteria
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
NCT ID
NCT01476566
First Posted
November 14, 2011
Last Updated
November 17, 2011
Sponsor
University of Oslo
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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