IMPROVinG Outcomes in Community Acquired Pneumonia

Pneumonia Clinical Trial

— IMPROVe-GAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835040
• Other study ID #: MH 2016.014
• Status: Completed
• Phase: N/A
• First received: May 22, 2016
• Last updated: November 2, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Western Health, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• New model of service delivery
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.
• Current practice
Interventions as determined by the treating General Medical team consistent with current usual practice.

Locations

Country	Name	City	State
Australia	Footscray Hospital	Footscray	Victoria
Australia	Sunshine Hospital	St Albans	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
Western Health, Australia	La Trobe University, Monash University, University of Melbourne

Country where clinical trial is conducted

Australia, 

References & Publications (6)

Blum CA, Nigro N, Briel M, Schuetz P, Ullmer E, Suter-Widmer I, Winzeler B, Bingisser R, Elsaesser H, Drozdov D, Arici B, Urwyler SA, Refardt J, Tarr P, Wirz S, Thomann R, Baumgartner C, Duplain H, Burki D, Zimmerli W, Rodondi N, Mueller B, Christ-Crain M. Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2015 Apr 18;385(9977):1511-8. doi: 10.1016/S0140-6736(14)62447-8. Epub 2015 Jan 19. — View Citation

Carratalà J, Garcia-Vidal C, Ortega L, Fernández-Sabé N, Clemente M, Albero G, López M, Castellsagué X, Dorca J, Verdaguer R, Martínez-Montauti J, Manresa F, Gudiol F. Effect of a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay in community-acquired pneumonia: a randomized controlled trial. Arch Intern Med. 2012 Jun 25;172(12):922-8. doi: 10.1001/archinternmed.2012.1690. — View Citation

Marti C, Grosgurin O, Harbarth S, Combescure C, Abbas M, Rutschmann O, Perrier A, Garin N. Adjunctive Corticotherapy for Community Acquired Pneumonia: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 7;10(12):e0144032. doi: 10.1371/journal.pone.0144032. eCollection 2015. Review. — View Citation

Mundy LM, Leet TL, Darst K, Schnitzler MA, Dunagan WC. Early mobilization of patients hospitalized with community-acquired pneumonia. Chest. 2003 Sep;124(3):883-9. — View Citation

Siemieniuk RA, Meade MO, Alonso-Coello P, Briel M, Evaniew N, Prasad M, Alexander PE, Fei Y, Vandvik PO, Loeb M, Guyatt GH. Corticosteroid Therapy for Patients Hospitalized With Community-Acquired Pneumonia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Oct 6;163(7):519-28. doi: 10.7326/M15-0715. Review. — View Citation

Torres A, Sibila O, Ferrer M, Polverino E, Menendez R, Mensa J, Gabarrús A, Sellarés J, Restrepo MI, Anzueto A, Niederman MS, Agustí C. Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):677-86. doi: 10.1001/jama.2015.88. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay		Through study completion, an average of five days
Secondary	Hospital readmissions		Within 30-days and 90-days of discharge
Secondary	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
Secondary	In-hospital mortality		15 months
Secondary	Proportion of patients receiving each individual evidence-based treatment recommendation		15 months
Secondary	Proportion of patients receiving all evidence-based treatment recommendations		15-months
Secondary	Incidence of hyperglycaemia in known diabetics requiring new insulin prescription		15-months
Secondary	Falls or clinical deterioration during physiotherapy		15-months
Secondary	Admission to Intensive Care Unit from medical ward during admission	Does not include admissions to ICU directly from the Emergency Department	15-months
Secondary	Duration of mechanical ventilation and number of failed extubations		15-months
Secondary	Death within 30-days of presentation to hospital		30-days from date of presentation to the Emergency Department
Secondary	Death within 90-days of presentation to hospital		90-days from date of presentation to the Emergency Department