Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT01476566
Status:
WITHDRAWN
Last Update Posted:
2024-02-09
First Post:
2011-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Diagnostics and Pharmacological Prescriptions in Patients With Heart Failure be Improved in General Practice?
Sponsor:
University of Oslo
Organization:
Study Overview
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.
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study was terminated before study start, no researcher was attached to the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: