IMPROVinG Outcomes in Community Acquired Pneumonia

NCT02835040 | Completed

• 1 other identifier: MH 2016.014
• Study Type: interventional
• Target: 814
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumonia

Keywords

Corticosteroid; Antibiotic; Early mobilization; Malnutrition

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  Through study completion, an average of five days

Secondary Outcomes (11)

• Hospital readmissions

  Within 30-days and 90-days of discharge

• Individual per-separation admission costing

  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

Study Arms (2)

CAP Service

EXPERIMENTAL

Other: New model of service delivery

Usual care

ACTIVE COMPARATOR

Other: Current practice

Interventions

New model of service delivery OTHER

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.

CAP Service

Current practice OTHER

Interventions as determined by the treating General Medical team consistent with current usual practice.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Health, Australia: lead
• University of Melbourne: collaborator
• Monash University: collaborator
• La Trobe University: collaborator

Study Sites (2)

Footscray Hospital

Footscray, Victoria, 3011, Australia

Location

Sunshine Hospital

St Albans, Victoria, 3442, Australia

Location

Related Publications (9)

• 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.

  PMID: 25608756 BACKGROUND

• 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.

  PMID: 12970012 BACKGROUND

• 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.

  PMID: 22732747 BACKGROUND

• 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.

  PMID: 26258555 BACKGROUND

• 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.

  PMID: 26641253 BACKGROUND

• 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.

  PMID: 25688779 BACKGROUND

• 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.

  PMID: 31372236 DERIVED

• 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.

  PMID: 31282921 DERIVED

• 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.

  PMID: 29402313 DERIVED

MeSH Terms

Conditions

Pneumonia; Malnutrition

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: May 22, 2016
• First Posted: July 15, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)