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Trial registered on ANZCTR


Registration number
ACTRN12618001548224
Ethics application status
Approved
Date submitted
13/09/2018
Date registered
17/09/2018
Date last updated
17/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An evidence-based research approach to improving outcomes and reducing hospital-acquired complications in patients with rib fractures: Chest Injury bundle of care Protocol (ChIP)
Scientific title
Retrospective pre-post evaluation of the impact of an evidence-based protocol for management of patients with blunt chest injury under real-world conditions: Chest Injury bundle of care Protocol (ChIP)
Secondary ID [1] 296031 0
None
Universal Trial Number (UTN)
U1111-1220-1029
Trial acronym
ChIP
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Rib fractures
309572 0
Blunt chest injury 309573 0
Condition category
Condition code
Injuries and Accidents 308396 308396 0 0
Other injuries and accidents
Injuries and Accidents 308467 308467 0 0
Fractures
Public Health 308468 308468 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intervention is the Chest Injury bundle of care Protocol (ChIP) - which includes a set of evidence-informed interventions for patients presenting with blunt chest injury. ChIP provides a flowchart for the identification of patients with blunt chest injury in the emergency department who are at risk of deterioration. Once identified a pager system is activated that alerts the surgical team, physiotherapist, intensive care registrar and liaison nurse, pain and aged care teams to review the patient within 60 minutes. The flowchart than provides guidelines for evidence-informed management of the patient. This includes oxygenation such as high flow nasal prongs, analgesia and supportive interventions such as deep breathing exercises.
ChIP has already been implemented at three hospitals using behaviour change theories in November 2017. ChIP will be observed from 22 November 2017 to June 2019.

Intervention code [1] 312374 0
Not applicable
Comparator / control treatment
Patients at the sites where the intervention has been implemented (after Novemeber 2017) will be compared to patients who were at hospitals where ChIP had not been implemented and patients at sites where ChIP was implemented before November 2017.

These patients would be receiving the "standard treatment", which is the usual care delivered by the hospital.

Routinely collected patient and health services data linked to retrospectively collected health data to determine incidence and outcomes of cases with blunt chest injury admitted to the hospitals from 1 July 2017 to 30 June 2019 for non-ChIP sites and 1 July 2015 to 21 November 2017 for ChIP sites.
Control group
Historical

Outcomes
Primary outcome [1] 307365 0
Rates of non-invasive ventilation pre-and post-implementing the ChIP protocol compared to contemporaneous rates with current standard practice as assessed by data linkage to medical records
Timepoint [1] 307365 0
While an inpatient
Secondary outcome [1] 351623 0
a) The proportion of patients who die in hospital as assessed by data linkage to medical records
Timepoint [1] 351623 0
While an inpatient
Secondary outcome [2] 351624 0
b) The proportion of patients who required an unplanned intensive care (ICU) admission as assessed by data linkage to medical records
Timepoint [2] 351624 0
While an inpatient
Secondary outcome [3] 351625 0
c) The proportion of patients who required activation of the hospital rapid response team (RTT) for clinical deterioration as assessed by data linkage to medical records
Timepoint [3] 351625 0
While an inpatient
Secondary outcome [4] 351626 0
d) The proportion of patients who experienced the respiratory complication of pneumonia as assessed by data linkage to medical records
Timepoint [4] 351626 0
While inpatient or return to hospital for same
Secondary outcome [5] 351627 0
e) The acute treatment costs for patients with blunt chest injury as assessed by data linkage to medical records
Timepoint [5] 351627 0
While an inpatient

Eligibility
Key inclusion criteria
Blunt thoracic trauma mechanism
Adult greater or equal to 18 years
Admitted to hospital
Rib/sternum fracture (clinical or radiological diagnosis)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Injury occurred while in hospital for other reason (activation system not possible)
Major cognitive impairment (patients are unable to participate in the care bundle)
Intubated Prehospital or in the emergency department

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Sample Size: Based on feasibility studies conducted in 2011 and 2014, a sample size of 788, with 394 patients in each arm will be required to demonstrate a significant reduction in non-invasive ventilation (as an indication of respiratory deterioration) to detect a clinically important reduction in complications of 10%, at alpha 0.05.

Demographic Data
Baseline demographic data (age, sex etc) will be analysed to compare characteristics between groups receiving CHIP and groups not receiving ChIP, and also to compare the pre and post ChIP groups using Chi-Squared test for categorical data and T-test (or non-parametric equivalent) for interval data. A patient disposition flow-chart will be presented showing the number of eligible subjects from each site. Summary statistics will be presented for continuous variables and counts, and percentages presented for categorical variables.

Incidence of blunt chest injury
The trend in the change of incidence rates pre-and-post ChIP will be tested by comparing the regression coefficients in different segments. Incidence rates between ChIP and No ChIP hospitals will also be compared using Chi-squared test.

Primary Outcome Analysis
Differences in the need for non-invasive ventilation (NIV) will be analysed using Generalised Mixed Methods, specifically Poisson regression with a random effect to account for hospital-level clustering.
A comparison of the relative change in NIV pre-and-post ChiP will be conducted using Segmented Regression modelling technique with the annual incidence rate as the outcome measure and year as the study variable with the inclusion of the other important covariates.
Cox models, which allow for fixed and time-dependent covariates and for different incidence rates in different time segments, will be used to determine whether NIV rates differed between cohorts before ChIP was implemented and whether post-ChIP NIV incidence rates between cohorts differed from pre-ChIP incidence rates. The Wald chi-square statistic will be used to test whether the incidence rates of NIV for blunt chest injury patients changed significantly from before to after the ChIP, comparing cohorts.


Secondary outcome Analysis

Secondary outcomes will be compared using multivariable regression. Potential confounders to consider in the regression models are injury severity score, Charlson Comorbidity Index, injury mechanism, tube thoracostomy, number of rib fractures, pulmonary contusion, pneumothorax and haemothorax. Initially, each potential confounding variable will be examined using univariate analysis to determine their association with the outcome. If there are small counts in any outcomes, proportions will be compared using Fischer’s exact test.

Uptake analysis
Baseline demographic data (age, sex etc), time to analgesia, pain team and physiotherapist review, use of high flow nasal prongs, patient controlled analgesia or other modes of analgesia will be analysed to compare characteristics between ChIP and “no ChIP” groups. The analysis will be using Chi-Squared test for categorical data and T-test (or non-parametric equivalent) for interval data. No adjusted analysis is required as this will assess the effectiveness of protocol implementation.


Asha SE, Curtis KA, Taylor C, Kwok A. Patient-controlled analgesia compared with interval analgesic dosing for reducing complications in blunt thoracic trauma: a retrospective cohort study. Emergency Medicine Journal. 2013;30:1024-8.

Curtis K, Asha SE, Unsworth A, Lam M, Goldsmith H, Langcake M, et al. ChIP: An early activation protocol for isolated blunt chest injury improves outcomes, a retrospective cohort study. AENJ. 2016;19:127-32.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11818 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 11819 0
Shoalhaven Hospital - Nowra
Recruitment hospital [3] 11820 0
St George Hospital - Kogarah
Recruitment hospital [4] 11821 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 11822 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [6] 11823 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 23945 0
2500 - Wollongong
Recruitment postcode(s) [2] 23946 0
2541 - Nowra
Recruitment postcode(s) [3] 23947 0
2217 - Kogarah
Recruitment postcode(s) [4] 23948 0
2065 - St Leonards
Recruitment postcode(s) [5] 23949 0
2077 - Hornsby
Recruitment postcode(s) [6] 23950 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 300622 0
Charities/Societies/Foundations
Name [1] 300622 0
HCF Research Foundation
Address [1] 300622 0
The Hospitals Contribution
Fund of Australia Limited
HCF House
403 George Street
Sydney NSW 2000
Country [1] 300622 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 300133 0
None
Name [1] 300133 0
Address [1] 300133 0
Country [1] 300133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301410 0
NSW Population and Health Services Research Ethics Committee
Ethics committee address [1] 301410 0
PO Box 41
Alexandria NSW 1435
Ethics committee country [1] 301410 0
Australia
Date submitted for ethics approval [1] 301410 0
24/11/2017
Approval date [1] 301410 0
25/07/2018
Ethics approval number [1] 301410 0
2017/HRE1205

Summary
Brief summary
Blunt chest injury can cause significant morbidity and mortality if not treated appropriately. An evidence-based, multidisciplinary early notification mechanism and care bundle for patients with isolated blunt chest wall injury was implemented as the standard of care at three NSW sites in 2017. This was named the Chest Injury bundle of care Protocol (ChIP)
This is a retrospective multi-site observational evaluation of ChIP, specifically a comparison of hospitals that currently use ChIP with hospitals that do not use ChIP, and also pre- and post-comparison at hospitals with ChIP. This study is a real-world evaluation of the effect of the protocol (ChIP) on patients, health service outcomes and costing. The implementation processes will also be evaluated.

The primary outcome measure is non-invasive ventilation to investigate if the implementation of ChIP will result in a reduced incidence of patients with isolated blunt chest injury requiring NIV. NIV is considered an indication of respiratory deterioration.

Evaluation will be using retrospectively collected data linked to NSW Admitted Patient Data Collection (APDC) data and NSW Activity Based Funding data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86902 0
Prof Kate Curtis
Address 86902 0
The University of Sydney, Faculty of Medicine and Health
A5.19, MO2 | 88 Mallett St,Camperdown | NSW | 2006
Country 86902 0
Australia
Phone 86902 0
+61 2 93510604
Fax 86902 0
Email 86902 0
kate.curtis@sydney.edu.au
Contact person for public queries
Name 86903 0
Prof Kate Curtis
Address 86903 0
The University of Sydney, Faculty of Medicine and Health
A5.19, MO2 | 88 Mallett St,Camperdown | NSW | 2006
Country 86903 0
Australia
Phone 86903 0
+61 2 93510604
Fax 86903 0
Email 86903 0
kate.curtis@sydney.edu.au
Contact person for scientific queries
Name 86904 0
Prof Kate Curtis
Address 86904 0
The University of Sydney, Faculty of Medicine and Health
A5.19, MO2 | 88 Mallett St,Camperdown | NSW | 2006
Country 86904 0
Australia
Phone 86904 0
+61 2 93510604
Fax 86904 0
Email 86904 0
kate.curtis@sydney.edu.au

No data has been provided for results reporting
Summary results
Not applicable