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IMPROVinG Outcomes in Community Acquired Pneumonia (IMPROVe-GAP)

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
New model of service delivery
Current practice
Sponsored by
Western Health, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumonia focused on measuring Corticosteroid, Antibiotic, Early mobilization, Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Footscray Hospital
  • Sunshine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAP Service

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Hospital length of stay

Secondary Outcome Measures

Hospital readmissions
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.
In-hospital mortality
Proportion of patients receiving each individual evidence-based treatment recommendation
Proportion of patients receiving all evidence-based treatment recommendations
Incidence of hyperglycaemia in known diabetics requiring new insulin prescription
Falls or clinical deterioration during physiotherapy
Admission to Intensive Care Unit from medical ward during admission
Does not include admissions to ICU directly from the Emergency Department
Duration of mechanical ventilation and number of failed extubations
Death within 30-days of presentation to hospital
Death within 90-days of presentation to hospital

Full Information

First Posted
May 22, 2016
Last Updated
November 2, 2017
Sponsor
Western Health, Australia
Collaborators
University of Melbourne, Monash University, La Trobe University
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1. Study Identification

Unique Protocol Identification Number
NCT02835040
Brief Title
IMPROVinG Outcomes in Community Acquired Pneumonia
Acronym
IMPROVe-GAP
Official Title
Evaluating the Impact of a New Model of Care Designed to Improve Evidence-based Management of Community-acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Health, Australia
Collaborators
University of Melbourne, Monash University, La Trobe University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Corticosteroid, Antibiotic, Early mobilization, Malnutrition

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
814 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAP Service
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
New model of service delivery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Current practice
Intervention Description
Interventions as determined by the treating General Medical team consistent with current usual practice.
Primary Outcome Measure Information:
Title
Hospital length of stay
Time Frame
Through study completion, an average of five days
Secondary Outcome Measure Information:
Title
Hospital readmissions
Time Frame
Within 30-days and 90-days of discharge
Title
Individual per-separation admission costing
Description
Total cost per admission that can be directly attributed to patient inpatient stay as recorded by the Power Performance Manager software platform.
Time Frame
From admission to emergency department until 90-days post-discharge
Title
In-hospital mortality
Time Frame
15 months
Title
Proportion of patients receiving each individual evidence-based treatment recommendation
Time Frame
15 months
Title
Proportion of patients receiving all evidence-based treatment recommendations
Time Frame
15-months
Title
Incidence of hyperglycaemia in known diabetics requiring new insulin prescription
Time Frame
15-months
Title
Falls or clinical deterioration during physiotherapy
Time Frame
15-months
Title
Admission to Intensive Care Unit from medical ward during admission
Description
Does not include admissions to ICU directly from the Emergency Department
Time Frame
15-months
Title
Duration of mechanical ventilation and number of failed extubations
Time Frame
15-months
Title
Death within 30-days of presentation to hospital
Time Frame
30-days from date of presentation to the Emergency Department
Title
Death within 90-days of presentation to hospital
Time Frame
90-days from date of presentation to the Emergency Department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Footscray Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3442
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25608756
Citation
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.
Results Reference
background
PubMed Identifier
12970012
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. doi: 10.1378/chest.124.3.883.
Results Reference
background
PubMed Identifier
22732747
Citation
Carratala J, Garcia-Vidal C, Ortega L, Fernandez-Sabe N, Clemente M, Albero G, Lopez M, Castellsague X, Dorca J, Verdaguer R, Martinez-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.
Results Reference
background
PubMed Identifier
26258555
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.
Results Reference
background
PubMed Identifier
26641253
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.
Results Reference
background
PubMed Identifier
25688779
Citation
Torres A, Sibila O, Ferrer M, Polverino E, Menendez R, Mensa J, Gabarrus A, Sellares J, Restrepo MI, Anzueto A, Niederman MS, Agusti 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.
Results Reference
background
PubMed Identifier
31372236
Citation
Lloyd MA, Tang CY, Callander EJ, Janus ED, Karahalios A, Skinner EH, Lowe S, Karunajeewa HA. Patient-reported outcome measurement in community-acquired pneumonia: feasibility of routine application in an elderly hospitalized population. Pilot Feasibility Stud. 2019 Jul 27;5:97. doi: 10.1186/s40814-019-0481-y. eCollection 2019.
Results Reference
derived
PubMed Identifier
31282921
Citation
Lloyd M, Karahalios A, Janus E, Skinner EH, Haines T, De Silva A, Lowe S, Shackell M, Ko S, Desmond L, Karunajeewa H; Improving Evidence-Based Treatment Gaps and Outcomes in Community-Acquired Pneumonia (IMPROVE-GAP) Implementation Team at Western Health. Effectiveness of a Bundled Intervention Including Adjunctive Corticosteroids on Outcomes of Hospitalized Patients With Community-Acquired Pneumonia: A Stepped-Wedge Randomized Clinical Trial. JAMA Intern Med. 2019 Aug 1;179(8):1052-1060. doi: 10.1001/jamainternmed.2019.1438.
Results Reference
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PubMed Identifier
29402313
Citation
Skinner EH, Lloyd M, Janus E, Ong ML, Karahalios A, Haines TP, Kelly AM, Shackell M, Karunajeewa H. The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial. Trials. 2018 Feb 5;19(1):88. doi: 10.1186/s13063-017-2407-4.
Results Reference
derived

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IMPROVinG Outcomes in Community Acquired Pneumonia

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