IMPROVinG Outcomes in Community Acquired Pneumonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pneumonia

Intervention / Treatment
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* Other: New model of service delivery
* Other: Current practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting to Footscray or Sunshine Hospital meeting the standardized definition for community acquired pneumonia. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAP Service<br> | Other: New model of service delivery<br>* Introduction of a new CAP disease specific clinical team to ensure systematic implementation of standardized treatment protocols (similar to a clinical pathway) for interventions supported by Level-1 evidence.<br>|
| Active Comparator: Usual care<br> | Other: Current practice<br>* Interventions as determined by the treating General Medical team consistent with current usual practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay |  | Through study completion, an average of five days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmissions |  | Within 30-days and 90-days of discharge | 
| Individual per-separation admission costing | Total cost per admission that can be directly attributed to patient inpatient stay as recorded by the Power Performance Manager software platform. | From admission to emergency department until 90-days post-discharge | 
| In-hospital mortality |  | 15 months | 
| Proportion of patients receiving each individual evidence-based treatment recommendation |  | 15 months | 
| Proportion of patients receiving all evidence-based treatment recommendations |  | 15-months | 
| Incidence of hyperglycaemia in known diabetics requiring new insulin prescription |  | 15-months | 
| Falls or clinical deterioration during physiotherapy |  | 15-months | 
| Admission to Intensive Care Unit from medical ward during admission | Does not include admissions to ICU directly from the Emergency Department | 15-months | 
| Duration of mechanical ventilation and number of failed extubations |  | 15-months | 
| Death within 30-days of presentation to hospital |  | 30-days from date of presentation to the Emergency Department | 
| Death within 90-days of presentation to hospital |  | 90-days from date of presentation to the Emergency Department | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corticosteroid, Antibiotic, Early mobilization, Malnutrition