for the Improving Evidence-Based Treatment Gaps and Outcomes in Community-Acquired Pneumonia (IMPROVE-GAP) Implementation Team at Western Health IMPORTANCE Community-acquired pneumonia remains a leading cause of hospitalization, mortality, and health care costs worldwide. Randomized clinical trials support the use of adjunctive corticosteroids, early progressive mobilization, antibiotic switching rules, and dietary interventions in improving outcomes. However, it is uncertain whether implementing these interventions will translate into effectiveness under routine health care conditions. OBJECTIVE To evaluate the effectiveness of a bundle of evidence-supported treatments under conditions of routine care in a representative population hospitalized for community-acquired pneumonia. DESIGN, SETTING, AND PARTICIPANTSA double-blind, stepped-wedge, cluster-randomized clinical trial with 90-day follow-up was conducted between August 1, 2016, and October 29, 2017, in the general internal medicine service at 2 tertiary hospitals in Melbourne, Australia, among a consecutive sample of patients with community-acquired pneumonia. The primary analysis and preparation of results took place between May 14 and November 25, 2018.INTERVENTIONS Treating clinical teams were advised to prescribe prednisolone acetate, 50 mg/d, for 7 days (in the absence of any contraindication) and de-escalate from parenteral to oral antibiotics according to standardized criteria. Algorithm-guided early mobilization and malnutrition screening and treatment were also implemented. MAIN OUTCOMES AND MEASURESHospital length of stay, mortality, readmission, and intervention-associated adverse events (eg, gastrointestinal bleeding and hyperglycemia).RESULTS A total of 917 patients were screened, and 816 (351 women and 465 men; mean [SD] age, 76 [13] years) were included in the intention-to-treat analysis, with 401 patients receiving the intervention and 415 patients in the control group. An unadjusted geometric mean ratio of 0.95 (95% CI, 0.78-1.16) was observed for the difference in length of stay (days) between the intervention and control groups. Similarly, no significant differences were observed for the secondary outcomes of mortality and readmission, and the results remained unchanged after further adjustment for sex and age. The study reported higher proportions of gastrointestinal bleeding in the intervention group (9 [2.2%]) compared with the controls (3 [0.7%]), with an unadjusted estimated difference in mean proportions of 0.008 (95% CI, 0.005-0.010). CONCLUSIONS AND RELEVANCEThis bundled intervention including adjunctive corticosteroids demonstrated no evidence of effectiveness and resulted in a higher incidence of gastrointestinal bleeding. Efficacy of individual interventions demonstrated in clinical trials may not necessarily translate into effectiveness when implemented in combination and may even result in net harm.TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02835040
BackgroundCommunity-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/DesignThe 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.DiscussionIMPROVE-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 registrationClinicalTrials.gov, NCT02835040. Prospectively registered on 22 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2407-4) contains supplementary material, which is available to authorized users.
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