跳至主要内容
临床试验/NCT02835040
NCT02835040已完成不适用

Evaluating the Impact of a New Model of Care Designed to Improve Evidence-based Management of Community-acquired Pneumonia

Western Health, Australia4 个研究点 分布在 1 个国家目标入组 814 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
814
试验地点
4
主要终点
Hospital length of stay

研究概览

简要总结

Pneumonia is the commonest illness requiring hospitalization in Australia. Elderly patients account for most admissions and incur highest costs due to longer hospitalizations, higher readmission risks and poor functional outcomes. Previous clinical trials show a number of medical and allied health interventions can effectively shorten hospitalization or reduce readmissions, but these have been poorly and inconsistently applied in practice. This proposed research builds on previous studies by applying these interventions as a standardized combined package, evaluating their effectiveness in a "real world" Australian setting and quantifying effects on both clinical outcomes and health service costs.

详细描述

Each year community acquired pneumonia (CAP) causes 61,000 hospital admissions (2006-7 data) and incurs costs of more than AUD300 million in Australia. At the investigators' institution, over 1000 admissions per year have an average hospital length of stay (LOS) of 5 days and incur average clinical costs of AUD6,724 per admission (2012/13 data). Prolonged LOS not only has significant implications for organizational costs but is also strongly associated with adverse patient outcomes including loss of function due to de-conditioning and higher incidence of hospital-acquired adverse events including hospital-acquired infections, intravascular-device associated complications and antibiotic-related side effects. Reducing LOS therefore benefits both the patient and the health system. General Internal Medical (GIM) services manage the largest proportion of CAP patients at Western Health, with 47% of CAP admissions managed by GIM in 2012/13 (average age 75 with proportions with at least 1, 2 or 3 active co-morbidities 70%, 43% and 27% respectively). With population ageing, the elderly and highly multi-morbid population treated by GIM units will constitute the bulk of Australia's future health service burden for CAP.

A number of interventions for improving clinical outcomes in CAP are now supported by recently accrued level 1 evidence. Following a Cochrane review in 2011 that suggested adjunct corticosteroids accelerate time to clinical stability, a number of trials have since demonstrated favorable outcomes. Most notable are two landmark large randomized controlled trials (RCT); a study of the effect of corticosteroid on reducing treatment failure in severe CAP published in JAMA, and a study published in the Lancet in 2015 that demonstrated faster clinical recovery and shorter LOS (by 1 day) without significant adverse events.10 A subsequent meta-analysis (2000 patients from 12 RCTs) confirmed these findings and routine adjunctive corticosteroid is now widely supported though as yet not consistently deployed. Early mobilization safely and effectively reduces LOS when applied appropriately as does early switch to oral antibiotics guided by a set of well-defined basic clinical and laboratory criteria. Recently, a RCT incorporating both measures demonstrated a LOS reduction of 2 days compared to standard care. A meta-analysis of nutritional support in malnourished medical inpatients (a patient cohort that includes those admitted with CAP) showed that systematic screening for risk of malnutrition and targeted nutritional therapy intervention reduces non-elective readmission rates.

No existing study has assessed bundling all four established interventions (corticosteroid, early switch to oral antibiotics, early mobilization and systematic screening for malnutrition and targeted nutritional therapy). However, adherence to consensus guidelines for CAP is notoriously poor suggesting the major challenge will be in bridging the "evidence-practice gap" and particularly changing clinician behavior. Generalist clinicians are becoming increasingly overwhelmed by a plethora of guidelines for multiple illnesses that may co-exist in the same patient. Currently at Western Health, 43% of CAP patients receive corticosteroids, 63% physiotherapy (median time to initiation 2 days) and 65% a guideline-compliant antibiotic. No parenteral antibiotic stopping rules are in place (median 3 days). There is a current compliance rate of 72% for malnutrition risk screening in inpatients across the health service. The investigators believe therefore, that in order to address this gap between evidence and practice, an alternative service model is necessary to ensure best practice specifically for this leading contributor to health service burden.

The investigators propose evaluating a stand-alone over-arching "syndrome-based" clinical service for CAP analogous to those already applied in other areas (e.g. "stroke-services" credited with substantial improvements in outcomes from acute cerebrovascular disease). The proposed "CAP Service" would have core responsibility for ensuring comprehensive and rigorous current evidence-based best practice by application of a standardized set of management algorithms incorporating interventions supported by Level 1 evidence.

Service evaluation will take the form of a stepped wedge study design, a type of cluster RCT that is particularly well-suited to implementation and health services research. Importantly, the investigators have already successfully implemented this design in health services research at Western Health. The primary research question is to quantify the impact of a dedicated CAP Service delivering consistent and standardized evidence-based care on length of stay, costs, 30- and 90-day readmission rates and mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

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

  • Patients presenting to Footscray or Sunshine Hospital meeting the standardized definition for community acquired pneumonia.

排除标准

  • Palliated on admission.
  • Enrolled in another inpatient clinical trial.
  • Withdrawal Criteria:
  • Transferred to a non-General Medical Unit within 48-hours of admission.
  • Transferred to another health service within 48-hours of admission.

结局指标

主要结局

Hospital length of stay

时间窗: Through study completion, an average of five days

次要结局

  • Hospital readmissions(Within 30-days and 90-days of discharge)
  • In-hospital mortality(15 months)
  • Individual per-separation admission costing(From admission to emergency department until 90-days post-discharge)
  • Admission to Intensive Care Unit from medical ward during admission(15-months)
  • Incidence of hyperglycaemia in known diabetics requiring new insulin prescription(15-months)
  • Falls or clinical deterioration during physiotherapy(15-months)
  • Proportion of patients receiving each individual evidence-based treatment recommendation(15 months)
  • Duration of mechanical ventilation and number of failed extubations(15-months)
  • Proportion of patients receiving all evidence-based treatment recommendations(15-months)
  • Death within 90-days of presentation to hospital(90-days from date of presentation to the Emergency Department)
  • Death within 30-days of presentation to hospital(30-days from date of presentation to the Emergency Department)

研究者

发起方
Western Health, Australia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Melanie Lloyd

Research Coordinator

Western Health, Australia

研究点 (4)

Loading locations...

相似试验