Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001182785
Ethics application status
Approved
Date submitted
30/08/2022
Date registered
2/09/2022
Date last updated
2/09/2022
Date data sharing statement initially provided
2/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
What is the effect of preoperative education on postoperative pulmonary complications following upper abdominal surgery
Scientific title
Investigating the effect of preoperative education, on the incidence of postoperative pulmonary complications following upper abdominal surgery at John Hunter Hospital
Secondary ID [1] 307866 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pulmonary complications following upper abdominal surgery 327493 0
Upper abdominal surgery 327494 0
Condition category
Condition code
Oral and Gastrointestinal 324614 324614 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 324615 324615 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention is identical to that provided by Boden I, El-Ansary D, Zalucki N, et al. Physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity: a nested mixed-methods randomised-controlled study. Physiotherapy. 2018;104(2):194-202. (ACTRN12613000664741)

This study is examining the pragmatic delivery of the intervention (within a NSW health district and utilising telehealth for delivery) used in this study - effect on postoperative pulmonary complications and the feasibility of its delivery in a tertiary hospital.

The intervention comprises 2 components. These are:
1. A 20-minute education session that is delivered 1:1 with a physiotherapist trained specifically in delivery of the relevant information. This information delivered in this education session is related to the effects of anaesthesia and surgery on the lungs, what to expect after surgery, and education regarding deep breathing breathing exercises that can be practiced before the surgery and that should be commenced immediately after surgery (ie. prior to the physiotherapist seeing the patient).
2. A handout with this information included in both text and graphical representations.

The intervention will be provided either via face-to-face or via teleconference with audio only, whichever mode of delivery is preferable to the patient. It will be provided within 6 weeks prior to surgery. A physiotherapist who is with more than 1 year clinical experience, will provide the intervention.

The handout is identical to that developed by Boden et al (2018) with details pertaining to JHH included. Exercises within the handout mirror that presented by the physiotherapist including deep breathing exercises, supported cough and early mobility.

All physiotherapists delivering the intervention will undergo training in the delivery of the education session. This will comprise a single 2 hour workshop delivered by a senior physiotherapist with more than 10 years clinical experience in cardiorespiratory physiotherapy. These physiotherapists will also perform their first session in pairs (with permission from the participant), where formative feedback from the second physiotherapist (also a trainee in the intervention) will be provided to ensure the session is delivered appropriately. Training will occur at least 1 month prior to recruitment of the first participant.
Intervention code [1] 324340 0
Prevention
Comparator / control treatment
The comparator group comprises 48 patients who underwent upper abdominal surgery at John Hunter Hospital between November 2021 and June 2022. These patients did not receive any preoperative education ie. usual care, and underwent their surgery prior to commencement of the intervention.
Control group
Historical

Outcomes
Primary outcome [1] 332431 0
Postoperative pulmonary complication as measured by the Melbourne Group Score
Timepoint [1] 332431 0
Daily in the 7 days following surgery
Primary outcome [2] 332432 0
Feasibility of delivering peroperative education prior to surgery as measured by proportion of patients who receive the education compared with those who are eligible. The proportion of patients who receive the education will be determined by an audit of the study database and the proportion of patients who are eligible will be determined by an audit of the study screening and enrollment logs.
Timepoint [2] 332432 0
Assessed at the conclusion of the study
Secondary outcome [1] 413463 0
Hospital length of stay as measured by data-linkage to medical records
Timepoint [1] 413463 0
Until acute care hospital discharge
Secondary outcome [2] 413471 0
Other non-pulmonary complications including cardiac complications, wound or urinary infections, falls etc. identified via medical records
Timepoint [2] 413471 0
Daily in the 7 days following surgery

Eligibility
Key inclusion criteria
All patients 18 years and older, assessed and consented by the John Hunter Hospital Perioperative service for planned upper abdominal surgery,
At least one abdominal incision above the umbilicus and below the diaphragm that is greater than 5cm in length.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE
The sample size has been calculated for the outcome of rate of postoperative pulmonary complications (PPC).

An examination of data for John Hunter Hospital (JHH) PPC rates in June 2022 identified the rate of PPCs in a sample of 48 patients is 25%.

In previously published data, the intervention led to a 50% relative risk reduction (RRR). Therefore, in the first instance we propose that the intervention be powered for a PPC rate of 25% down to 12%. However, we have decided to factor an 'uncertainty’ buffer into our calculations that the effect won’t be as strong compared with the published data (given the published data was an ‘ideal’ face-to-face process, and our process is pragmatic and including telehealth options) or the current baseline sample is not representative of the broader population. Therefore, we have powered for 40% RRR equating to an absolute risk reduction of 10% ie. Rate of PPC s from 25% to 15% following implementation of the intervention.

Based on inference for a single proportion comparing to a known proportion with a=0.05 and power at 80% a post-cohort sample of 133 is required if the baseline PPC rate is 0.25 and a reduction to 0.15 is detected.

STATISTICAL METHODS
The feasibility of delivery of this intervention within the patient cohort at JHH will be determined by the proportion of patients who agree to participate and are provided the education session through either face-to-face or telehealth delivery.

The rate of PPCs following implementation of education session will be examined and compared with the rate of PPCs measured in a group who had their surgery prior to implementation of the intervention. The absolute and relative rates of PPCs will be estimated using multivariate robust random effects Poisson generalised linear regression.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/08/2022
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
183
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23050 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 38380 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 312141 0
Hospital
Name [1] 312141 0
Hunter New England Local Health District
Country [1] 312141 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
John Hunter Hospital
Lookout Road
New Lambton Heights. NSW. 2305
Country
Australia
Secondary sponsor category [1] 313665 0
None
Name [1] 313665 0
Address [1] 313665 0
Country [1] 313665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311535 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 311535 0
Ethics committee country [1] 311535 0
Australia
Date submitted for ethics approval [1] 311535 0
14/04/2022
Approval date [1] 311535 0
31/05/2022
Ethics approval number [1] 311535 0
2022/ETH0551

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121446 0
Dr Jennifer Mackney
Address 121446 0
Department of Physiotherapy
John Hunter Hospital
Lookout Road, New Lambton Heights. NSW. 2305
Country 121446 0
Australia
Phone 121446 0
+61 2 49217879
Fax 121446 0
Email 121446 0
[email protected]
Contact person for public queries
Name 121447 0
Jennifer Mackney
Address 121447 0
Department of Physiotherapy
John Hunter Hospital
Lookout Road, New Lambton Heights. NSW. 2305
Country 121447 0
Australia
Phone 121447 0
+61 2 49217879
Fax 121447 0
Email 121447 0
[email protected]
Contact person for scientific queries
Name 121448 0
Jennifer Mackney
Address 121448 0
Department of Physiotherapy
John Hunter Hospital
Lookout Road, New Lambton Heights. NSW. 2305
Country 121448 0
Australia
Phone 121448 0
+61 2 49217879
Fax 121448 0
Email 121448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable data collected as part of this study will be shared
When will data be available (start and end dates)?
Beginning immediately following publication and ending 5years following publication.
Available to whom?
Genuine researchers who agree to keep the information confidential and who are provided approval from the original research team.
Available for what types of analyses?
Any analyses as deemed suitable by the original researchers.
How or where can data be obtained?
Access subject to approval by Principal Investigator: Dr Jennifer Mackney, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17068Study protocol  [email protected]
17069Statistical analysis plan  [email protected]
17070Informed consent form  [email protected]
17071Ethical approval  [email protected]



Results publications and other study-related documents

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Documents added automatically
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