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