ANZCTR - Registration

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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

15/04/2024

Date data sharing statement initially provided

15/04/2024

Date results provided

15/04/2024

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]

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

Blunt chest injury

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Injuries and Accidents

Fractures

Public Health

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]

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]

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]

While an inpatient

Secondary outcome [1]

a) The proportion of patients who die in hospital as assessed by data linkage to medical records

Timepoint [1]

While an inpatient

Secondary outcome [2]

b) The proportion of patients who required an unplanned intensive care (ICU) admission as assessed by data linkage to medical records

Timepoint [2]

While an inpatient

Secondary outcome [3]

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]

While an inpatient

Secondary outcome [4]

d) The proportion of patients who experienced the respiratory complication of pneumonia as assessed by data linkage to medical records

Timepoint [4]

While inpatient or return to hospital for same

Secondary outcome [5]

e) The acute treatment costs for patients with blunt chest injury as assessed by data linkage to medical records

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

15/10/2018

Actual

27/09/2018

Date of last participant enrolment

Anticipated

Actual

7/02/2020

Date of last data collection

Anticipated

Actual

7/02/2020

Sample size

Target

788

Accrual to date

Final

1798

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Wollongong Hospital - Wollongong

Recruitment hospital [2]

Shoalhaven Hospital - Nowra

Recruitment hospital [3]

Hornsby Ku-ring-gai Hospital - Hornsby

Recruitment hospital [4]

Canterbury Hospital - Campsie

Recruitment postcode(s) [1]

2500 - Wollongong

Recruitment postcode(s) [2]

2541 - Nowra

Recruitment postcode(s) [3]

2077 - Hornsby

Recruitment postcode(s) [4]

2194 - Campsie

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

HCF Research Foundation

Address [1]

The Hospitals Contribution
Fund of Australia Limited
HCF House
403 George Street
Sydney NSW 2000

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NSW Population and Health Services Research Ethics Committee

Ethics committee address [1]

PO Box 41
Alexandria NSW 1435

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/11/2017

Approval date [1]

25/07/2018

Ethics approval number [1]

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 two 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

Prof Kate Curtis

Address

The University of Sydney, Faculty of Medicine and Health
A5.19, MO2 | 88 Mallett St,Camperdown | NSW | 2006

Country

Australia

Phone

+61 2 93510604

Fax

[email protected]

Contact person for public queries

Name

Kate Curtis

Address

The University of Sydney, Faculty of Medicine and Health
A5.19, MO2 | 88 Mallett St,Camperdown | NSW | 2006

Country

Australia

Phone

+61 2 93510604

Fax

[email protected]

Contact person for scientific queries

Name

Kate Curtis

Address

The University of Sydney, Faculty of Medicine and Health
A5.19, MO2 | 88 Mallett St,Camperdown | NSW | 2006

Country

Australia

Phone

+61 2 93510604

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
22195					Kourouche S, Curtis K, Munroe B, Buckley T. Impl... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of an intervention for patients 65 years and older with blunt chest injury: Patient and health service outcomes.	2022	https://dx.doi.org/10.1016/j.injury.2022.04.024

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically