NCT02905786

Brief Summary

Heart failure (HF) imposes a burden for patients and health economics. Although guidelines exist, they are not implemented as such in the Belgian health care system. General practitioners (GPs) are confronted with the broadest range of HF management. Therefore, a multifaceted intervention will be implemented in Belgian general practice to support GPs in the implementation of evidence-based HF guidelines. This multifaceted intervention will consist of audit and feedback as a method to detect unrecognized HF patients and increase awareness for proactive HF management. Additionally, a NT-proBNP point-of-care test will be offered to every practice to improve detection and adequate diagnosis of HF patients. Furthermore, a specialist HF nurse will assist GPs in education of patients, optimization of treatment and transition of care. The investigators' aim is evaluating the feasibility of the implementation of this multifaceted intervention in general practice and the evolution in predefined quality indicators.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

September 14, 2016

Last Update Submit

July 17, 2018

Conditions

Heart Failure

Keywords

General PracticeNurse practitionerNatriuretic peptidesClinical audit

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the use of NT-proBNP POC test

    How often do GPs use the POC test, for which indications, influence on decision-making?

    6 months

  • Evaluation of the use of specialized HF nurse assistance

    How often and for which indications do GPs use the assistance of the specialized HF nurse?

    6 months

Secondary Outcomes (8)

  • Adequacy of HF diagnosis

    6 months

  • Adequacy of HF treatment

    6 months

  • Evolution of HF patients' QoL

    6 months

  • Number of hospitalizations (all-cause, cardiovascular, HF-related)

    6 months

  • Mortality (all-cause/cardiovascular)

    6 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Experiences of GPs with a multifaceted intervention to optimize care

    6 months

Interventions

Cobas h232 (Roche Diagnostics)DEVICE

NT-proBNP point-of-care test

Clinical audit and feedbackOTHER

Clinical audit and feedback to detect previously unrecognized HF patients and inform GPs about their current quality of HF care

Assistance by a specialized HF nurseOTHER

Assistance by a specialized HF nurse in general practice for education of patients, advice in diagnosis and treatment, transition of care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure patients are included if:
  • They have their electronic medical records ("globaal medisch dossier") registered with one of the participating general practitioners.
  • They have a registered diagnosis of HF (ICPC-2 code K77 or free text) in their electronic health record (EHR).
  • Patients can be included during the study if:
  • They give their informed consent to participate in the study.
  • Are eligible for a NT-proBNP POC test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Public Health and Primary Care

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Smeets M, Raat W, Aertgeerts B, Penders J, Vercammen J, Droogne W, Mullens W, Janssens S, Vaes B. Mixed-methods evaluation of a multifaceted heart failure intervention in general practice: the OSCAR-HF pilot study. ESC Heart Fail. 2023 Apr;10(2):907-916. doi: 10.1002/ehf2.14251. Epub 2022 Dec 3.

    PMID: 36461750DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Clinical Audit

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Bert Aertgeerts, MD, PhD

    Department of Public Health and Primary Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 19, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

BE(1)