IMPROVinG Outcomes in Community Acquired Pneumonia (IMPROVe-GAP)

November 2, 2017 updated by: Melanie Lloyd, Western Health, Australia

Evaluating the Impact of a New Model of Care Designed to Improve Evidence-based Management of Community-acquired Pneumonia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each year community acquired pneumonia (CAP) causes 61,000 hospital admissions (2006-7 data) and incurs costs of more than AUD300 million in Australia. At the investigators' institution, over 1000 admissions per year have an average hospital length of stay (LOS) of 5 days and incur average clinical costs of AUD6,724 per admission (2012/13 data). Prolonged LOS not only has significant implications for organizational costs but is also strongly associated with adverse patient outcomes including loss of function due to de-conditioning and higher incidence of hospital-acquired adverse events including hospital-acquired infections, intravascular-device associated complications and antibiotic-related side effects. Reducing LOS therefore benefits both the patient and the health system. General Internal Medical (GIM) services manage the largest proportion of CAP patients at Western Health, with 47% of CAP admissions managed by GIM in 2012/13 (average age 75 with proportions with at least 1, 2 or 3 active co-morbidities 70%, 43% and 27% respectively). With population ageing, the elderly and highly multi-morbid population treated by GIM units will constitute the bulk of Australia's future health service burden for CAP.

A number of interventions for improving clinical outcomes in CAP are now supported by recently accrued level 1 evidence. Following a Cochrane review in 2011 that suggested adjunct corticosteroids accelerate time to clinical stability, a number of trials have since demonstrated favorable outcomes. Most notable are two landmark large randomized controlled trials (RCT); a study of the effect of corticosteroid on reducing treatment failure in severe CAP published in JAMA, and a study published in the Lancet in 2015 that demonstrated faster clinical recovery and shorter LOS (by 1 day) without significant adverse events.10 A subsequent meta-analysis (2000 patients from 12 RCTs) confirmed these findings and routine adjunctive corticosteroid is now widely supported though as yet not consistently deployed. Early mobilization safely and effectively reduces LOS when applied appropriately as does early switch to oral antibiotics guided by a set of well-defined basic clinical and laboratory criteria. Recently, a RCT incorporating both measures demonstrated a LOS reduction of 2 days compared to standard care. A meta-analysis of nutritional support in malnourished medical inpatients (a patient cohort that includes those admitted with CAP) showed that systematic screening for risk of malnutrition and targeted nutritional therapy intervention reduces non-elective readmission rates.

No existing study has assessed bundling all four established interventions (corticosteroid, early switch to oral antibiotics, early mobilization and systematic screening for malnutrition and targeted nutritional therapy). However, adherence to consensus guidelines for CAP is notoriously poor suggesting the major challenge will be in bridging the "evidence-practice gap" and particularly changing clinician behavior. Generalist clinicians are becoming increasingly overwhelmed by a plethora of guidelines for multiple illnesses that may co-exist in the same patient. Currently at Western Health, 43% of CAP patients receive corticosteroids, 63% physiotherapy (median time to initiation 2 days) and 65% a guideline-compliant antibiotic. No parenteral antibiotic stopping rules are in place (median 3 days). There is a current compliance rate of 72% for malnutrition risk screening in inpatients across the health service. The investigators believe therefore, that in order to address this gap between evidence and practice, an alternative service model is necessary to ensure best practice specifically for this leading contributor to health service burden.

The investigators propose evaluating a stand-alone over-arching "syndrome-based" clinical service for CAP analogous to those already applied in other areas (e.g. "stroke-services" credited with substantial improvements in outcomes from acute cerebrovascular disease). The proposed "CAP Service" would have core responsibility for ensuring comprehensive and rigorous current evidence-based best practice by application of a standardized set of management algorithms incorporating interventions supported by Level 1 evidence.

Service evaluation will take the form of a stepped wedge study design, a type of cluster RCT that is particularly well-suited to implementation and health services research. Importantly, the investigators have already successfully implemented this design in health services research at Western Health. The primary research question is to quantify the impact of a dedicated CAP Service delivering consistent and standardized evidence-based care on length of stay, costs, 30- and 90-day readmission rates and mortality.

Study Type

Interventional

Enrollment (Actual)

814

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital
      • St Albans, Victoria, Australia, 3442
        • Sunshine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting to Footscray or Sunshine Hospital meeting the standardized definition for community acquired pneumonia.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Other: Current practice
Interventions as determined by the treating General Medical team consistent with current usual practice.
Experimental: CAP Service
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital length of stay
Time Frame: Through study completion, an average of five days
Through study completion, an average of five days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital readmissions
Time Frame: Within 30-days and 90-days of discharge
Within 30-days and 90-days of discharge
Individual per-separation admission costing
Time Frame: From admission to emergency department until 90-days post-discharge
Total cost per admission that can be directly attributed to patient inpatient stay as recorded by the Power Performance Manager software platform.
From admission to emergency department until 90-days post-discharge
In-hospital mortality
Time Frame: 15 months
15 months
Proportion of patients receiving each individual evidence-based treatment recommendation
Time Frame: 15 months
15 months
Proportion of patients receiving all evidence-based treatment recommendations
Time Frame: 15-months
15-months
Incidence of hyperglycaemia in known diabetics requiring new insulin prescription
Time Frame: 15-months
15-months
Falls or clinical deterioration during physiotherapy
Time Frame: 15-months
15-months
Admission to Intensive Care Unit from medical ward during admission
Time Frame: 15-months
Does not include admissions to ICU directly from the Emergency Department
15-months
Duration of mechanical ventilation and number of failed extubations
Time Frame: 15-months
15-months
Death within 30-days of presentation to hospital
Time Frame: 30-days from date of presentation to the Emergency Department
30-days from date of presentation to the Emergency Department
Death within 90-days of presentation to hospital
Time Frame: 90-days from date of presentation to the Emergency Department
90-days from date of presentation to the Emergency Department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Health, Australia

Collaborators

Monash University
University of Melbourne
La Trobe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

May 22, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH 2016.014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on New model of service delivery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe