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Table 3 World Health Organization Trial Registration Data Set for IMPROVE-GAP trial

From: The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial

Data category Information
Primary registry and trial identifying number www.ClinicalTrials.gov, NCT02835040
Date of registration in primary registry 22 May 2016
Secondary identifying numbers Not applicable
Trial protocol version This is Version 3 of the protocol and was enacted on 24 August 2016
Source of monetary or material support The HCF Research Foundation (AU $300,000)
Primary sponsor The HCF Research Foundation
Secondary sponsor Not applicable
Contact for public queries HK, harin.karunajeewa@wh.org.au
Contact for scientific queries HK, harin.karunajeewa@wh.org.au
Public title IMPROVing Evidence-based treatment Gaps and outcomes in community-Acquired Pneumonia (IMPROVE-GAP).
Scientific title IMPROVE-GAP: Evaluating the impact of a new model of care designed to improve evidence-based management of community-acquired pneumonia
Country of recruitment Australia
Health condition or problem studied Community-acquired pneumonia
Intervention Active comparator: Evidence-based bundle of care (specifically: corticosteroids, early mobilisation, guideline-compliance antibiotic and early switch to oral antibiotic therapy, malnutrition risk screening and targeted nutritional therapy)
Placebo comparator: Usual inpatient care
Key inclusion and exclusion criteria Ages eligible for study: ≥ 18 yrs
Sexes eligible for study: Both
Accepts healthy volunteers: No
Inclusion criteria: All adults admitted to the institution under a general internal medicine unit with community-acquired pneumonia (meeting a standardised community-acquired pneumonia definition)
Exclusion criteria: (1) patients where a decision is made to implement palliative care on admission; (2) existing enrolment in a clinical trial.
Study type Type: Investigator-initiated, interventional, pragmatic, study
Allocation: Concealed randomisation
Intervention model: Stepped-wedge rollout
Masking: Patient and assessor blinded
Primary purpose: Treatment
Phase: Phase IV
Date of first enrolment 01/08/2016
Target sample size Minimum 640 patients
Recruitment status Recruiting
Primary outcome measure Hospital length of stay
Key secondary outcome measures Inpatient mortality, 30 and 90 day readmission rates and mortality, ICU admission and ventilation, total clinical costings, protocol adherence, serious adverse events