Implementation of a Multifaceted Intervention to Optimize Care for Heart Failure Patients in Primary Care: Protocol of a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 538
- 试验地点
- 1
- 主要终点
- Evaluation of the use of NT-proBNP POC test
研究概览
简要总结
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.
详细描述
Objectives:
The objective of this pilot study is to assess the feasibility of a multifaceted intervention to optimize care for HF patients in Belgian general practice. It is not a primary objective to study the effectiveness of the intervention on the defined outcomes, since follow-up might be too short, however the evolution in quality will be evaluated. Specific research questions are:
- Do general practitioners use the NT-proBNP POC test and how does it influence practice?
- Do general practitioners use the assistance of the HF nurse and how does it influence practice?
- Does this intervention improve quality of care for HF patients in primary care?
- Does this intervention improve quality of life for HF patients in primary care?
- Is this intervention/data collection method feasible? How do participating GPs and investigators experience the interventions?
Data collection:
- Measurements at baseline and after 6 months of follow-up
- Baseline demographic data on patient age, gender, years since the diagnosis of HF, cardiovascular comorbidities (hypertension, ischemic heart disease, valvular heart disease, atrial fibrillation, cerebrovascular disease, peripheral arterial disease), non-cardiovascular comorbidities (diabetes, depression, chronic obstructive pulmonary disease, dementia), the last two blood pressure measurements, last 2 creatinine measurements and the last two values of the estimated glomerular filtration rate (eGFR), last date of GP consultation, involvement of cardiologist (yes/no), last date of cardiologist appointment, echocardiography (yes/no), last date of echocardiography report, ejection fraction (EF), diastolic dysfunction (yes/no), clinically relevant valvular dysfunction (yes/no), left ventricular hypertrophy (yes/no), left atrial enlargement (yes/no) and heart failure treatment with dosage (diuretics, ACE-I, ARB, B-blockers, MRA, digoxin) will be collected. Additionally, the number of chronic medications and the number of chronic comorbidities will be collected. Furthermore, the MLHF-Q will be collected to evaluate patients' quality of life and grip strength (only at baseline) as a predictor of functional decline, disability and mortality. At baseline, HF hospitalization during the last three years will be registered based on discharge letters in the EHR. All hospitalizations and mortality will be collected at practice level during the study course. Data on physician age, gender, years of experience and practice organization (group/single-handed/number of practitioners/EMHS) will be requested as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •No exclusion criteria will be set
结局指标
主要结局
Evaluation of the use of NT-proBNP POC test
时间窗: 6 months
How often do GPs use the POC test, for which indications, influence on decision-making?
Evaluation of the use of specialized HF nurse assistance
时间窗: 6 months
How often and for which indications do GPs use the assistance of the specialized HF nurse?
次要结局
- Mortality (all-cause/cardiovascular)(6 months)
- Evolution of HF patients' QoL(6 months)
- Number of hospitalizations (all-cause, cardiovascular, HF-related)(6 months)
- Adequacy of follow-up(6 months)
- Adequacy of HF diagnosis(6 months)
- Adequacy of HF treatment(6 months)
- Adequacy of transition of care(6 months)
- Adequacy of specialized follow-up(6 months)