Implementing Standards of Care for Heart Failure Patients in General Practice - A Regional Disease Management Program
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- KU Leuven
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Yearly HF hospitalizations
Study Overview
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.
Detailed Description
The primary objective of this study is to establish a dynamic implementation environment for HF management in Leuven. It is not a primary objective to study the effect of various best clinical practices on the defined outcomes. We focus on the evolution in quality of HF management through an evaluation of the implementation process. Specific research questions are as follows:
- Do HF education and a learning environment improve the GPs' self-efficacy?
- Does reimbursement of the NT-proBNP test lead to implementation?
- How do primary care professionals and patients experience the introduction of a primary care HF educator?
- What is the adoption rate of a HF discharge checklist in hospitals' EHR? How do care professionals adhere to a checklist-supported structured discharge protocol?
- What is the feasibility of implementing automated audits in GPs EHR?
- Does this implementation study affect regional levels of HF hospitalization and readmissions?
Outcomes
Measurements at baseline We will register contact data (telephone number and/or mail address), and sociodemographic variables (age, sex and type of HF ) for patients who receive a HF educator contact and give informed consent. If it is an education-session post-discharge, we will ask if the patient had a contact with his/her GP.
We record patients' relevant risk criteria at discharge in the checklist.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Yearly HF hospitalizations
Time Frame: Three years
Secondary Outcomes
- 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)
Investigators
Willem Raat
Dr. Willem Raat
KU Leuven