FASTTRACK - Facilitated Access to Optimized Treatment and Clinical Follow-Up for Elderly Patients by the Internal Medicine Heart Failure Outpatient Clinic - a Randomized Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Region Skane
- 主要终点
- Quality of Life
研究概览
简要总结
Research problem and specific questions:
Due to lack of resources and an increasingly heavy burden placed on the primary care system, most of heart failure (HF) patients don´t receive a swift follow-up according to guideline recommendations. Our study aims to investigate if a structured and swift follow-up at a dedicated internal medicine HF out-patient clinic (IM-HF)) for older adults with HF post hospital discharge, can improve the quality of life and reduce mortality and re-hospitalization compared to current standard with follow-up within the primary care.
Data and method:
The study will be performed as a prospective, randomized controlled trial (RCT) at two sites. All patients older than 70 years admitted to a ward with new onset or chronic HF will be invited to participate. After discharge, all patients will be invited to a re-visit to the IM-HF within 2 weeks, and will thereafter be randomized to either continued follow-up on-demand at the IM-HF or within the primary care. Outcomes will be self-reported quality of life, number of days alive and out of hospital, time to death or re-hospitalization and adherence to guideline-directed medical therapy. Data collection will be performed by means of nurse-led interviews, blood sampling and review of medical records. By employing a RCT-design with a well-defined population, intervention, control and outcome, this study aims to provide high-quality evidence that could influence clinical practice.
Societal relevance and utilization:
The study is expected to give valuable insight into the effects of early and structured follow-up for older adults with HF and could improve the standard of care and lead to improved quality of life and reduced risks of re-hospitalization and mortality. Through multidisciplinary teams and cooperation with patients associations the study aspires to be evidence based and patient centered. The start-up and implementation of the study is expected during the following years and may have important implications for the care of older adults with HF.
Plan for project realization:
The study aims to start at the IM-HF at two sites in 2025 with a research nurse with a 50% position at each site. About 12 patients fulfilling the inclusion criteria are discharged from the hospital wards each week and we expect an inclusion rate of 4 patients/week. The study is expected to go on for 3.5 years.
详细描述
FASTTRACC - Facilitated AccesS To Optimized TReAtment and CliniCal follow-up for elderly patients by the internal medicine heart failure outpatient clinic - a randomized multicenter prospective study
- Abbreviations
HF - heart failure, GDMT - guideline directed medical therapy, DAOH - days alive and out-of-hospital, CRT - cardiac resynchronisation therapy, ICD - implantable cardiac defibrillator, IM-HF - internal medicine heart failure outpatient clinic, DIM - department of internal medicine, POCUS - point-of-care ultrasound 2. Background
Heart failure (HF) among older patients (more than 70 years of age) is one of the most common causes for hospital admission and re-admission.1 It is not only associated with increased mortality exceeding most malignant diseases, but also with a great amount of suffering and low quality of life for the patient, with repeated hospitalizations and inability to perform activities of daily life. HF also exerts a substantial financial burden on the healthcare system mostly driven by the high-rate of re-hospitalizations that accounts for more than 70% of the total HF health care cost.2,3 Thirty-day readmission rates are reported to be as high as 22-25% 4,5 and mortality risk increases for each subsequent readmission.3 Most of these patients are elderly and burdened by several co-morbidities rendering them ineligible for advanced HF treatment such as device therapy (CRT/ICD) or mechanical support. Following hospital discharge, a majority of HF patients are referred to their primary care provider for clinical follow-up and treatment optimization.6 Due to lack of resources and an increasingly heavy burden placed on the primary care system, most of these patients don't receive their follow-up until 1-2 months after hospitalization for an acute episode of HF, at which time many have already been re-admitted to the hospital.7 This practice is not in line with current guidelines that recommend early and frequent follow-up after HF hospitalization following the STRONG-HF trial. STRONG-HF studied an intensive treatment strategy of rapid up-titration of guideline-directed medication therapy (GDMT) and close follow-up after an HF admission and showed reduced symptoms, improved quality of life, and reduced the risk of 180-day all-cause death or HF readmission compared with usual care.8,9 However, as impressive and powerful the effects of the STRONG-HF trial were; the mean age of study participants were 63 years and less than 1700 patients were included from 14 countries and 87 hospitals during more than four years. This can, of course, partly be explained by the COVID-19 pandemic but still raises the question of STRONG-HF's applicability in the everyday real-world clinical setting with an elderly HF-population with multiple co-morbidities who are unlikely to tolerate the aggressive strategy enlisted in STRONG-HF. This creates an evidentiary vacuum for the elderly HF-patients and their response to intensified GDMT that our study intends to fill.
Almost half of all HF re-admissions are estimated to be a result of suboptimal transitional care i.e., the vulnerable phase between discharge from the hospital and initiation and continuity of care in the outpatient setting.10,11
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (paper-based or digital/remote)
- •70 years or older
- •Clinical diagnosis of HF
- •Follow-up after hospitalization would otherwise be in the primary care setting
排除标准
- •Eligibility to advanced HF treatment such as device therapy or mechanical support
- •Intended follow-up at the Department of Cardiology (electrical cardioversion excluded)
- •Inability to give informed consent
研究组 & 干预措施
Control arm
Patients in the control arm will receive follow-up post-discharge at the internal medicine heart failure outpatient clinic within 2 weeks. They will thereafter be referred to their primary care physician
Interventional arm
Patients in the interventional arm will receive follow-up post-discharge at the internal medicine heart failure outpatient clinic within 2 weeks. They will thereafter receive further follow-up at the internal medicine heart failure outpatient clinic on-demand for the following 6 months
干预措施: Swift follow-up (Other)
结局指标
主要结局
Quality of Life
时间窗: From enrollment and at 1-, 3- and 6-months
Quality of Life assessed by Kansas City Cardiomyopathy questionnaire, KCCQ
Days Alive and Out-of-hospital
时间窗: From enrollment and 1 year forward
Percentage of Days Alive and Out-of-hospital (%DAOH)
次要结局
- 1-year mortality and 30-day re-admission(From enrollment and 1 year forward for mortality. From enrollment and 30 days forward for re-admission)
- Adherence to guidline-directed medical therapy (GDMT)(From enrollment and at 1-, 3- and 6-months)
