Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care in Heart Failure Units and Independent Centers Utilizing Established Quality Indicators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 899
- 试验地点
- 1
- 主要终点
- Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint
研究概览
简要总结
This was a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient treatment and care following a decompensation event in different types of Heart Failure Unit (HFU) or non-HFU centers across Germany.
详细描述
This study aimed to describe quality of care of HFrEF patients following a decompensation event in different center types (=settings) utilizing the quality indicators for the care and outcomes of adults with heart failure as specified by the Heart Failure Association in 2022.
No strict visit schedule was imposed on participants to avoid interference with routine clinical care. HFrEF patients were treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data was collected as part of the study from patient files.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who provide written informed consent to participate in the study
- •Male or female patients ≥ 18 years of age
- •Patients with diagnosis of heart failure with reduced ejection fraction (HFrEF) and HF treatment according to the summaries of product characteristics (SmPCs)
- •Decompensation event up to three months prior to inclusion
排除标准
- •Simultaneous or planned participation in an interventional research study
- •Participation in this study at another site e.g. in a HFU network
- •Patients incapable of understanding and signing the informed consent form
结局指标
主要结局
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint
时间窗: 6 months
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based QI composite endpoint defined by the number of times each of secondary endpoints has been accomplished divided by chances to accomplish them as average per center type. To describe the quality of Heart Failure (HF) patient care in Heart Failure Unit (HFU) and non-HFU centers utilizing QIs as suggested by the 2021 European Society of Cardiology HF guideline.
次要结局
- Proportion of sites with a dedicated multidisciplinary team to manage patients with HF(Baseline)
- (C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)(3 months)
- (H) Proportion of patients treated with an Angiotensin-converting enzymes (ACE) inhibitor, Angiotensin receptor blocker (ARB) or Angiotensin receptor-neprilysin inhibitor (ARNI) in the absence of any contraindications(6 months)
- Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.(Baseline)
- (G) Proportion of patients treated with beta-blocker bisoprolol, carvedilol, sustained-release metoprolol succinate, or nebivolol in the absence of any contraindications as defined by Aktaa et al 2022(6 months)
- (A) Proportion of patients with HF who have a documentation of their HF clinical type(Baseline)
- (B) Proportion of patients with a documentation of their electrocardiogram findings(6 months)
- (D) Proportion of patients who have their blood tests documented(3 months)
- (E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program(6 months)
- (F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge(4 weeks)
- (I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications(6 months)
- (J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications(6 months)
- Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment(6 months)
- Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention(6 months)
- Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together(6 months)
- Percentage of days covered with all four treatment classes(6 months)
- (K) Proportion of symptomatic patients with HFrEF in sinus rhythm with a QRS duration ≥150ms and left bundle branch block QRS morphology and with LVEF ≤35% despite ≥3 months optimal medical therapy who are offered cardiac resynchronization therapy(6 months)
- (L) Proportion of symptomatic patients with HF, LVEF ≤35% despite ≥3 months of optimal medical therapy, and ischemic heart disease (IHD) who are offered primary prevention implantable cardioverter defibrillator(6 months)
- Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool(6 months)
- Number of patients who are eligible for and have accomplished secondary endpoint g-j divided by the number of patients who are eligible for g-j(6 months)
- Number of HF hospitalizations, stratified by bed type(6 months)
- Length of hospital stay(6 months)
- Number of HF hospitalizations per patient(6 months)
- Number of newly implanted devices(6 months)
- Number of valve interventions(6 months)
- Number of participants with medical history of selected comorbidities(Baseline)