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IMPROVinG Outcomes in Community Acquired Pneumonia (IMPROVe-GAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02835040
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
University of Melbourne
Monash University
La Trobe University
Information provided by (Responsible Party):
Melanie Lloyd, Western Health, Australia

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.

Condition or disease Intervention/treatment Phase
Pneumonia Other: New model of service delivery Other: Current practice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 814 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluating the Impact of a New Model of Care Designed to Improve Evidence-based Management of Community-acquired Pneumonia
Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: CAP Service 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.

Active Comparator: Usual care Other: Current practice
Interventions as determined by the treating General Medical team consistent with current usual practice.




Primary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Through study completion, an average of five days ]

Secondary Outcome Measures :
  1. Hospital readmissions [ Time Frame: Within 30-days and 90-days of discharge ]
  2. Individual per-separation admission costing [ Time Frame: From admission to emergency department until 90-days post-discharge ]
    Total cost per admission that can be directly attributed to patient inpatient stay as recorded by the Power Performance Manager software platform.

  3. In-hospital mortality [ Time Frame: 15 months ]
  4. Proportion of patients receiving each individual evidence-based treatment recommendation [ Time Frame: 15 months ]
  5. Proportion of patients receiving all evidence-based treatment recommendations [ Time Frame: 15-months ]
  6. Incidence of hyperglycaemia in known diabetics requiring new insulin prescription [ Time Frame: 15-months ]
  7. Falls or clinical deterioration during physiotherapy [ Time Frame: 15-months ]
  8. Admission to Intensive Care Unit from medical ward during admission [ Time Frame: 15-months ]
    Does not include admissions to ICU directly from the Emergency Department

  9. Duration of mechanical ventilation and number of failed extubations [ Time Frame: 15-months ]
  10. Death within 30-days of presentation to hospital [ Time Frame: 30-days from date of presentation to the Emergency Department ]
  11. Death within 90-days of presentation to hospital [ Time Frame: 90-days from date of presentation to the Emergency Department ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835040


Locations
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Australia, Victoria
Footscray Hospital
Footscray, Victoria, Australia, 3011
Sunshine Hospital
St Albans, Victoria, Australia, 3442
Sponsors and Collaborators
Western Health, Australia
University of Melbourne
Monash University
La Trobe University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Melanie Lloyd, Research Coordinator, Western Health, Australia
ClinicalTrials.gov Identifier: NCT02835040    
Other Study ID Numbers: MH 2016.014
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Melanie Lloyd, Western Health, Australia:
Corticosteroid
Antibiotic
Early mobilization
Malnutrition
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections