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

NCT04334447 | Unknown Phase 4

• 1 other identifier: S68238
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Primary Care; Community Care; General Practice; Self-management; Education; Transitional intervention; Chronic Care; Natriuretic Peptides; Audit and feedback; Electronic Health Record; GP training

Outcome Measures

Primary Outcomes (1)

• Yearly HF hospitalizations

  Three years

Secondary Outcomes (4)

• Yearly cardiology consultations

  Three years

• Yearly echocardiographies

  Three years

• Registered HF diagnoses in the EHR

  Three years

• HF self-efficacy: EHFScBS-9 questionnaire

  At baseline and after 6 months

Other Outcomes (3)

• Number of registered natriuretic peptide tests

  Three years

• Number of registered HF education sessions

  Three years

• Number of completed discharge checklists

  Three years

Study Arms (1)

Intervention Group Patients

EXPERIMENTAL

All HF patients that experience a HF education session

Other: Improved primary care HF diagnostics; Other: Heart Failure education; Other: Structured transitional protocol planning post-discharge care

Interventions

Improved primary care HF diagnostics OTHER

Reimbursement of natriuretic peptide testing for participating general practitioners (GPs) Audit and feedback in GPs EHR

Intervention Group Patients

Heart Failure education OTHER

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

Intervention Group Patients

Structured transitional protocol planning post-discharge care OTHER

Checklist-supported discharge protocol for HF patients including telephone contact with patients' general practitioners and a contact with the HF educator

Intervention Group Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosis of HF

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Academisch Centrum Huisartsgeneeskunde

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (2)

• Raat W, Smeets M, Van Pottelbergh G, Van de Putte M, Janssens S, Vaes B. Implementing heart failure disease management in primary care: a mixed-methods analysis of the IMPACT-B study. BMJ Open. 2025 Jul 20;15(7):e093414. doi: 10.1136/bmjopen-2024-093414.

  PMID: 40685241 DERIVED

• Raat W, Smeets M, Van Pottelbergh G, Van de Putte M, Janssens S, Vaes B. Implementing standards of care for heart failure patients in general practice - the IMPACT-B study protocol. Acta Cardiol. 2021 Jul;76(5):486-493. doi: 10.1080/00015385.2020.1844504. Epub 2020 Nov 9.

  PMID: 33161831 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bert Vaes

  KU Leuven

  STUDY DIRECTOR

Central Study Contacts

Willem Raat

CONTACT

016 37 66 21; willem.raat@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Willem Raat

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: November 4, 2019
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2022
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)