PneumoniaIMPROVe-GAPNCT02835040
IMPROVinG Outcomes in Community Acquired Pneumonia
A study testing New model of service delivery and Current practice in people with Pneumonia, run by Western Health, Australia at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- New model of service delivery and Current practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 2 sitesAustralia
- Study dates
- Aug 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to Footscray or Sunshine Hospital meeting the standardized definition for community acquired pneumonia.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Footscray Hospital
Footscray, Victoria, 3011
Sunshine Hospital
St Albans, Victoria, 3442
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- New model of service delivery, Current practice
- Keywords
- Corticosteroid, Antibiotic, Early mobilization, Malnutrition
- Medical subject headings
- Pneumonia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New model of service deliveryOther
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.
Current practiceOther
Interventions as determined by the treating General Medical team consistent with current usual practice.
| Study group | Role | What they receive |
|---|---|---|
| CAP Service | Experimental | Not described Receives: Other: New model of service delivery |
| Usual care | Active comparator | Not described Receives: Other: Current practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Measured: Through study completion, an average of five days
Secondary outcomes (11)
Hospital readmissions
Measured: Within 30-days and 90-days of discharge
Individual per-separation admission costing
Total cost per admission that can be directly attributed to patient inpatient stay as recorded by the Power Performance Manager software platform.
Measured: From admission to emergency department until 90-days post-discharge
In-hospital mortality
Measured: 15 months
Proportion of patients receiving each individual evidence-based treatment recommendation
Measured: 15 months
Proportion of patients receiving all evidence-based treatment recommendations
Measured: 15-months
Incidence of hyperglycaemia in known diabetics requiring new insulin prescription
Measured: 15-months
Falls or clinical deterioration during physiotherapy
Measured: 15-months
Admission to Intensive Care Unit from medical ward during admission
Does not include admissions to ICU directly from the Emergency Department
Measured: 15-months
Duration of mechanical ventilation and number of failed extubations
Measured: 15-months
Death within 30-days of presentation to hospital
Measured: 30-days from date of presentation to the Emergency Department
Death within 90-days of presentation to hospital
Measured: 90-days from date of presentation to the Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Health, Australia
- Sponsor type
- Other government
- Collaborators
- University of Melbourne, Monash University, La Trobe University
- Responsible party
- Principal investigator, Melanie Lloyd, Western Health, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835040
- Sponsor's protocol ID
- MH 2016.014
- Acronym
- IMPROVe-GAP
- Status last verified
- Nov 2017
- First submitted
- 22 May 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Blum CA, Nigro N, Briel M, Schuetz P, Ullmer E, Suter-Widmer I, Winzeler B, Bingisser R, Elsaesser H, Drozdov D, Arici B, Urwyler SA, Refardt J, Tarr P, Wirz S, Thomann R, Baumgartner C, Duplain H, Burki D, Zimmerli W, Rodondi N, Mueller B, Christ-Crain M. Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2015 Apr 18;385(9977):1511-8. doi: 10.1016/S0140-6736(14)62447-8. Epub 2015 Jan 19.
PubMed 25608756Mundy LM, Leet TL, Darst K, Schnitzler MA, Dunagan WC. Early mobilization of patients hospitalized with community-acquired pneumonia. Chest. 2003 Sep;124(3):883-9. doi: 10.1378/chest.124.3.883.
PubMed 12970012Carratala J, Garcia-Vidal C, Ortega L, Fernandez-Sabe N, Clemente M, Albero G, Lopez M, Castellsague X, Dorca J, Verdaguer R, Martinez-Montauti J, Manresa F, Gudiol F. Effect of a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay in community-acquired pneumonia: a randomized controlled trial. Arch Intern Med. 2012 Jun 25;172(12):922-8. doi: 10.1001/archinternmed.2012.1690.
PubMed 22732747Siemieniuk RA, Meade MO, Alonso-Coello P, Briel M, Evaniew N, Prasad M, Alexander PE, Fei Y, Vandvik PO, Loeb M, Guyatt GH. Corticosteroid Therapy for Patients Hospitalized With Community-Acquired Pneumonia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Oct 6;163(7):519-28. doi: 10.7326/M15-0715.
PubMed 26258555Marti C, Grosgurin O, Harbarth S, Combescure C, Abbas M, Rutschmann O, Perrier A, Garin N. Adjunctive Corticotherapy for Community Acquired Pneumonia: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 7;10(12):e0144032. doi: 10.1371/journal.pone.0144032. eCollection 2015.
PubMed 26641253Torres A, Sibila O, Ferrer M, Polverino E, Menendez R, Mensa J, Gabarrus A, Sellares J, Restrepo MI, Anzueto A, Niederman MS, Agusti C. Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):677-86. doi: 10.1001/jama.2015.88.
PubMed 25688779Lloyd MA, Tang CY, Callander EJ, Janus ED, Karahalios A, Skinner EH, Lowe S, Karunajeewa HA. Patient-reported outcome measurement in community-acquired pneumonia: feasibility of routine application in an elderly hospitalized population. Pilot Feasibility Stud. 2019 Jul 27;5:97. doi: 10.1186/s40814-019-0481-y. eCollection 2019.
PubMed 31372236Lloyd M, Karahalios A, Janus E, Skinner EH, Haines T, De Silva A, Lowe S, Shackell M, Ko S, Desmond L, Karunajeewa H; Improving Evidence-Based Treatment Gaps and Outcomes in Community-Acquired Pneumonia (IMPROVE-GAP) Implementation Team at Western Health. Effectiveness of a Bundled Intervention Including Adjunctive Corticosteroids on Outcomes of Hospitalized Patients With Community-Acquired Pneumonia: A Stepped-Wedge Randomized Clinical Trial. JAMA Intern Med. 2019 Aug 1;179(8):1052-1060. doi: 10.1001/jamainternmed.2019.1438.
PubMed 31282921Skinner EH, Lloyd M, Janus E, Ong ML, Karahalios A, Haines TP, Kelly AM, Shackell M, Karunajeewa H. The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial. Trials. 2018 Feb 5;19(1):88. doi: 10.1186/s13063-017-2407-4.
PubMed 29402313
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a New Model of Care Designed to Improve Evidence-based Management of Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT02835040
- Acronym / sponsor ID
- IMPROVe-GAP / MH 2016.014
- Conditions
- Pneumonia
- Keywords
- Corticosteroid, Antibiotic, Early mobilization, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Western Health, AustraliaOther government
- Collaborators
- University of Melbourne, Monash University, La Trobe University
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAP Service | Experimental | Other: New model of service delivery |
| Usual care | Active comparator | Other: Current practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting to Footscray or Sunshine Hospital meeting the standardized definition for community acquired pneumonia.
Key exclusion criteria (5 listed)
- Palliated on admission.
- Enrolled in another inpatient clinical trial.
- Transferred to a non-General Medical Unit within 48-hours of admission.
- Transferred to another health service within 48-hours of admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New model of service deliveryIntroduction 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. | Other | CAP Service |
| Current practiceInterventions as determined by the treating General Medical team consistent with current usual practice. | Other | Usual care |
Primary outcome
Hospital length of stay
Time frame: Through study completion, an average of five days
11 secondary outcomes
Hospital readmissions
Time frame: 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
In-hospital mortality
Time frame: 15 months
Proportion of patients receiving each individual evidence-based treatment recommendation
Time frame: 15 months
Proportion of patients receiving all evidence-based treatment recommendations
Time frame: 15-months
Incidence of hyperglycaemia in known diabetics requiring new insulin prescription
Time frame: 15-months
Falls or clinical deterioration during physiotherapy
Time frame: 15-months
Admission to Intensive Care Unit from medical ward during admission
Time frame: 15-months
Duration of mechanical ventilation and number of failed extubations
Time frame: 15-months
Death within 30-days of presentation to hospital
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Background: PubMed 25608756Blum CA, Nigro N, Briel M, Schuetz P, Ullmer E, Suter-Widmer I, Winzeler B, Bingisser R, Elsaesser H, Drozdov D, Arici B, Urwyler SA, Refardt J, Tarr P, Wirz S, Thomann R, Baumgartner C, Duplain H, Burki D, Zimmerli W, Rodondi N, Mueller B, Christ-Crain M. Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2015 Apr 18;385(9977):1511-8. doi: 10.1016/S0140-6736(14)62447-8. Epub 2015 Jan 19.
- Background: PubMed 12970012Mundy LM, Leet TL, Darst K, Schnitzler MA, Dunagan WC. Early mobilization of patients hospitalized with community-acquired pneumonia. Chest. 2003 Sep;124(3):883-9. doi: 10.1378/chest.124.3.883.
- Background: PubMed 22732747Carratala J, Garcia-Vidal C, Ortega L, Fernandez-Sabe N, Clemente M, Albero G, Lopez M, Castellsague X, Dorca J, Verdaguer R, Martinez-Montauti J, Manresa F, Gudiol F. Effect of a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay in community-acquired pneumonia: a randomized controlled trial. Arch Intern Med. 2012 Jun 25;172(12):922-8. doi: 10.1001/archinternmed.2012.1690.
- Background: PubMed 26258555Siemieniuk RA, Meade MO, Alonso-Coello P, Briel M, Evaniew N, Prasad M, Alexander PE, Fei Y, Vandvik PO, Loeb M, Guyatt GH. Corticosteroid Therapy for Patients Hospitalized With Community-Acquired Pneumonia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Oct 6;163(7):519-28. doi: 10.7326/M15-0715.
- Background: PubMed 26641253Marti C, Grosgurin O, Harbarth S, Combescure C, Abbas M, Rutschmann O, Perrier A, Garin N. Adjunctive Corticotherapy for Community Acquired Pneumonia: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 7;10(12):e0144032. doi: 10.1371/journal.pone.0144032. eCollection 2015.
- Background: PubMed 25688779Torres A, Sibila O, Ferrer M, Polverino E, Menendez R, Mensa J, Gabarrus A, Sellares J, Restrepo MI, Anzueto A, Niederman MS, Agusti C. Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):677-86. doi: 10.1001/jama.2015.88.
- Derived from this study: PubMed 31372236Lloyd MA, Tang CY, Callander EJ, Janus ED, Karahalios A, Skinner EH, Lowe S, Karunajeewa HA. Patient-reported outcome measurement in community-acquired pneumonia: feasibility of routine application in an elderly hospitalized population. Pilot Feasibility Stud. 2019 Jul 27;5:97. doi: 10.1186/s40814-019-0481-y. eCollection 2019.
- Derived from this study: PubMed 31282921Lloyd M, Karahalios A, Janus E, Skinner EH, Haines T, De Silva A, Lowe S, Shackell M, Ko S, Desmond L, Karunajeewa H; Improving Evidence-Based Treatment Gaps and Outcomes in Community-Acquired Pneumonia (IMPROVE-GAP) Implementation Team at Western Health. Effectiveness of a Bundled Intervention Including Adjunctive Corticosteroids on Outcomes of Hospitalized Patients With Community-Acquired Pneumonia: A Stepped-Wedge Randomized Clinical Trial. JAMA Intern Med. 2019 Aug 1;179(8):1052-1060. doi: 10.1001/jamainternmed.2019.1438.
- Derived from this study: PubMed 29402313Skinner EH, Lloyd M, Janus E, Ong ML, Karahalios A, Haines TP, Kelly AM, Shackell M, Karunajeewa H. The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial. Trials. 2018 Feb 5;19(1):88. doi: 10.1186/s13063-017-2407-4.
- Individual participant dataSharing planned: No
Related trials for Pneumonia
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New model of service delivery and Current practice in people with Pneumonia, run by Western Health, Australia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: Through study completion, an average of five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835040, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.