Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02835040




Registration number
NCT02835040
Ethics application status
Date submitted
22/05/2016
Date registered
15/07/2016
Date last updated
6/11/2017

Titles & IDs
Public title
IMPROVinG Outcomes in Community Acquired Pneumonia
Scientific title
Evaluating the Impact of a New Model of Care Designed to Improve Evidence-based Management of Community-acquired Pneumonia
Secondary ID [1] 0 0
MH 2016.014
Universal Trial Number (UTN)
Trial acronym
IMPROVe-GAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - New model of service delivery
Other interventions - Current practice

Experimental: CAP Service -

Active Comparator: Usual care -


Other interventions: 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.

Other interventions: Current practice
Interventions as determined by the treating General Medical team consistent with current usual practice.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hospital length of stay
Timepoint [1] 0 0
Through study completion, an average of five days
Secondary outcome [1] 0 0
Hospital readmissions
Timepoint [1] 0 0
Within 30-days and 90-days of discharge
Secondary outcome [2] 0 0
Individual per-separation admission costing
Timepoint [2] 0 0
From admission to emergency department until 90-days post-discharge
Secondary outcome [3] 0 0
In-hospital mortality
Timepoint [3] 0 0
15 months
Secondary outcome [4] 0 0
Proportion of patients receiving each individual evidence-based treatment recommendation
Timepoint [4] 0 0
15 months
Secondary outcome [5] 0 0
Proportion of patients receiving all evidence-based treatment recommendations
Timepoint [5] 0 0
15-months
Secondary outcome [6] 0 0
Incidence of hyperglycaemia in known diabetics requiring new insulin prescription
Timepoint [6] 0 0
15-months
Secondary outcome [7] 0 0
Falls or clinical deterioration during physiotherapy
Timepoint [7] 0 0
15-months
Secondary outcome [8] 0 0
Admission to Intensive Care Unit from medical ward during admission
Timepoint [8] 0 0
15-months
Secondary outcome [9] 0 0
Duration of mechanical ventilation and number of failed extubations
Timepoint [9] 0 0
15-months
Secondary outcome [10] 0 0
Death within 30-days of presentation to hospital
Timepoint [10] 0 0
30-days from date of presentation to the Emergency Department
Secondary outcome [11] 0 0
Death within 90-days of presentation to hospital
Timepoint [11] 0 0
90-days from date of presentation to the Emergency Department

Eligibility
Key inclusion criteria
- Patients presenting to Footscray or Sunshine Hospital meeting the standardized
definition for community acquired pneumonia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
Accrual to date
Final
814
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Footscray Hospital - Footscray
Recruitment hospital [2] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
3011 - Footscray
Recruitment postcode(s) [2] 0 0
3442 - St Albans

Funding & Sponsors
Primary sponsor type
Other
Name
Western Health, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
La Trobe University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02835040
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries