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Implementing Standards of Care for Heart Failure Patients in General Practice - A Regional Disease Management Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04334447
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Information provided by (Responsible Party):
Willem Raat, KU Leuven

Brief Summary:
Heart failure (HF) is an important health problem. Most chronic HF management occurs in primary care. Although guidelines exist, there is an important implementation gap in current HF care in Belgium. We will conduct a non-randomized, non-controlled prospective observational trial to implement guideline-recommended best clinical practices in primary care in Leuven, a region of ± 100.000 inhabitants. These best clinical practices include education of general practitioners, access to natriuretic peptides and audits in the electronic health record (EHR), training and implementation of HF educators in primary care and a structured post-discharge transition process . The main objective is to implement best clinical practices in a dynamic way and study the implementation process. We will evaluate the implementation of several guideline-recommended best clinical practices to optimize the diagnosis and treatment of heart failure in a real-world primary care setting.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Improved primary care HF diagnostics Other: Heart Failure education Other: Structured transitional protocol planning post-discharge care Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementing Standards of Care for Heart Failure Patients in General Practice - A Regional Disease Management Program
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Intervention Group Patients
All HF patients that experience a HF education session
Other: Improved primary care HF diagnostics
Reimbursement of natriuretic peptide testing for participating general practitioners (GPs) Audit and feedback in GPs EHR

Other: Heart Failure education
Reimbursement of heart failure education for patients at risk. Web-based training for participating general practitioners

Other: Structured transitional protocol planning post-discharge care
Checklist-supported discharge protocol for HF patients including telephone contact with patients' general practitioners and a contact with the HF educator

Primary Outcome Measures :
  1. Yearly HF hospitalizations [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. Yearly cardiology consultations [ Time Frame: Three years ]
  2. Yearly echocardiographies [ Time Frame: Three years ]
  3. Registered HF diagnoses in the EHR [ Time Frame: Three years ]
  4. HF self-efficacy: EHFScBS-9 questionnaire [ Time Frame: At baseline and after 6 months ]
    Patient self-efficacy as measured by the EHFScBS-9 questionnaire

Other Outcome Measures:
  1. Number of registered natriuretic peptide tests [ Time Frame: Three years ]
    Number of NT-proBNP tests conducted by participating GPs

  2. Number of registered HF education sessions [ Time Frame: Three years ]
  3. Number of completed discharge checklists [ Time Frame: Three years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


- Diagnosis of HF


- No pre-specified exclusion criteria

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 identifier (NCT number): NCT04334447

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Contact: Willem Raat 016 37 66 21

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Academisch Centrum Huisartsgeneeskunde Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Willem Raat    016 37 66 21   
Sponsors and Collaborators
KU Leuven
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Study Director: Bert Vaes KU Leuven
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Willem Raat, Dr. Willem Raat, KU Leuven Identifier: NCT04334447    
Other Study ID Numbers: S68238
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Willem Raat, KU Leuven:
Primary Care
Community Care
General Practice
Transitional intervention
Chronic Care
Natriuretic Peptides
Audit and feedback
Electronic Health Record
GP training
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases