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

Elizabeth H Skinner, Melanie Lloyd, Edward Janus, May Lea Ong, Amalia Karahalios, Terry P Haines, Anne-Maree Kelly, Melina Shackell, Harin Karunajeewa, Elizabeth H Skinner, Melanie Lloyd, Edward Janus, May Lea Ong, Amalia Karahalios, Terry P Haines, Anne-Maree Kelly, Melina Shackell, Harin Karunajeewa

Abstract

Background: Community-acquired pneumonia is a leading worldwide cause of hospital admissions and healthcare resource consumption. The largest proportion of hospitalisations now occurs in older patients, with high rates of multimorbidity and complex care needs. In Australia, this population is usually managed by hospital inpatient general internal medicine units. Adherence to consensus best-practice guidelines is poor. Ensuring evidence-based care and reducing length of stay may improve patient outcomes and reduce organisational costs. This study aims to evaluate an alternative model of care designed to improve adherence to four Level 1 or 2 evidence-supported interventions (routine corticosteroids, early switch to oral antibiotics, early mobilisation and routine malnutrition screening).

Methods/design: The IMPROVing Evidence-based treatment Gaps and outcomes in community-Acquired Pneumonia (IMPROVE-GAP) trial is a pragmatic, investigator-initiated, stepped-wedge randomised trial. Patients hospitalised under a general internal medicine unit who meet a standard case definition for community-acquired pneumonia will be included. Eight general internal medicine units at two Australian hospitals in a single health service will be randomised using concealed allocation to: (i) usual medical, nursing and allied health care delivered according to existing organisational practice or (ii) care supported by a dedicated "community-acquired pneumonia service": a multidisciplinary team deploying algorithm-based implementation of a bundle of the four evidence-based interventions. The primary outcome measure will be length of hospital stay. Secondary outcome measures include inpatient mortality, 30 and 90 day readmission rates and mortality and health-service utilisation costs. Protocol adherence will be measured and reported, and serious adverse events (rates of hyperglycaemia requiring new insulin; falls during mobilisation) will be collected and reported.

Discussion: IMPROVE-GAP represents an important and unique precedent for testing a new service-delivery model for improving compliance with a number of evidence-based interventions. Its stepped-wedge randomised controlled trial design provides a means to address some significant ethical, organisational and other methodological challenges to evaluating the effectiveness of health-service interventions in complex hospital populations. The new service-delivery model will effectively be fully implemented by trial completion, facilitating rapid, seamless translation into practice should care outcomes be superior. This trial is currently recruiting.

Trial registration: ClinicalTrials.gov, NCT02835040. Prospectively registered on 22 May 2016.

Keywords: Antibiotic; Community-acquired pneumonia; Corticosteroids; Early mobilisation; Malnutrition; Randomised controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol was approved by the hospital’s institutional review board (Melbourne Health Human Research Ethics Committee [Protocol reference: MH2016.014]). As part of the ethical approval, a waiver of the requirement for individual participant informed consent was sought and granted, as outlined in the study protocol.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Stepped-wedge rollout of community-acquired pneumonia service by general internal medicine unit
Fig. 2
Fig. 2
CONSORT flow diagram of IMPROVE-GAP. CAP, community-acquired pneumonia; GIM, general internal medicine; ICU, intensive care unit; LOS, length of stay; SAE, serious adverse event
Fig. 3
Fig. 3
Summary diagram of stepped-wedge design. CAP, community-acquired pneumonia; RCT, randomised controlled trial
Fig. 4
Fig. 4
Schedule of enrolment, interventions and assessments (as per SPIRIT [33]). D/C, discharge; ED, emergency department; GIM, general internal medicine; ICU, intensive care unit

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