跳至主要内容
临床试验/NCT04334447
NCT04334447Unknown4 期

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

KU Leuven2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
4 期
发起方
KU Leuven
入组人数
200
试验地点
2
主要终点
Yearly HF hospitalizations

研究概览

简要总结

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.

详细描述

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:

  1. Do HF education and a learning environment improve the GPs' self-efficacy?
  2. Does reimbursement of the NT-proBNP test lead to implementation?
  3. How do primary care professionals and patients experience the introduction of a primary care HF educator?
  4. 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?
  5. What is the feasibility of implementing automated audits in GPs EHR?
  6. 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Yearly HF hospitalizations

时间窗: Three years

次要结局

  • 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)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Willem Raat

Dr. Willem Raat

KU Leuven

研究点 (2)

Loading locations...

相似试验