Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000333617
Ethics application status
Approved
Date submitted
16/03/2023
Date registered
30/03/2023
Date last updated
3/04/2024
Date data sharing statement initially provided
30/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the acceptability and treatment fidelity of digital pre-operative education to face-to-face physiotherapy pre-operative education in patients awaiting elective thoracic surgery: A pilot feasibility randomised controlled trial.
Scientific title
Comparing the acceptability and treatment fidelity of digital pre-operative education to face-to-face physiotherapy pre-operative education in patients awaiting elective thoracic surgery: A pilot feasibility randomised controlled trial.
Secondary ID [1] 309224 0
Grant reference number: NI2022-15
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracic surgery 329376 0
Post-operative pulmonary complications (PPCs) 329377 0
Condition category
Condition code
Surgery 326320 326320 0 0
Other surgery
Public Health 326409 326409 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 2: Digital pre-operative education
The objectives of this feasibility pilot study are to investigate whether pre-operative physiotherapy education delivered via digital video has similar acceptability and treatment fidelity as education delivered face-to-face in patients undergoing thoracic surgery.
Eligible participants will be randomly allocated by concealed allocation to receive either face-to-face pre-operative education by a physiotherapist (Group 1) or digital video pre-operative education via a laptop, tablet, or mobile device (Group 2). Post-operative physiotherapy input will reflect current practice at The Prince Charles Hospital (TPCH) and be delivered by the ward physiotherapist, including education, mobilisation, and respiratory care. Discharge from physiotherapy will follow criteria as per current practice for both groups, and information provided at discharge will be consistent.
Investigators at TPCH will screen pre-admission clinic (PREAC), theatre and thoracic surgical ward lists daily for eligible patients. Potential participants will be met by one of the investigators (either in PREAC or on the ward, depending on where the patient is identified by the investigators) and provided with verbal information about the trial as well as a written information sheet (appendix 1). Once consented, trial participants will be randomly allocated to receive either face-to-face pre-operative physiotherapy education (group 1), or digital video pre-operative physiotherapy education (group 2).
Participants allocated to group 2 will receive digital video pre-operative education; a 15 minute professionally made, educational video shown on a laptop, tablet, phone, or other device. Participants will also be provided with a link to the video, allowing them to watch it as many times as they like on a personal device (reflecting the likely clinical practice when implemented). As with the face-to-face group, the location and timing of when these participants receive their pre-operative education is based on when they were consented (i.e. those consented in pre-admission clinic will be shown the digital video whilst in pre-admission clinic, and those recruited and consented on the ward will be shown the digital video while on the ward). The patients in this group will receive the video as their primary source of education, and as they are not seeing a physiotherapist to provide this education, a subjective assessment will not be undertaken prior to surgery. Any information which is usually gathered as part of a pre-operative review will be collected by the ward physiotherapist post-operatively as part of a standard initial patient assessment. After the investigator consents the patient and they are allocated to receive digital video education, the investigator will provide the participant with the tablet containing the digital video, as well as a link to the video to take with them, and will then leave the patient to watch the education and collect the tablet at a later time. After watching the digital video and prior to having surgery, a ward physiotherapist will as the participant if they have any questions about the video, and will answer accordingly. Any questions asked will be documented.
Digital video education includes the same type of information that is provided in face-to-face education listed above, including education on deep breathing exercises (with and without an incentive spirometer), supported coughing, circulation exercises, early mobility, and the rationale for all these interventions. Additionally, the video includes demonstrations of deep breathing exercises, supported cough and animations to support the educational content. This group will not have the opportunity to practice the incentive spirometer prior to surgery but will be provided with an incentive spirometer post-operatively by the ward physiotherapist.
Adherence to the intervention will be monitored via recorded semi-scripted interviews on day 3-5 post-operatively and will include questions to check participant recall of receiving intervention as well as recall of content.



Intervention code [1] 325668 0
Prevention
Comparator / control treatment
Group 1: Face-to-face pre-operative education
Participants randomly allocated into group 1 will receive face-to-face pre-operative education from a physiotherapist, either in pre-admission clinic or on the ward, depending on their location when they consented to the trial. Reflecting current practice, education will be provided by the physiotherapist working in the thoracic surgical wards on that day, or another physiotherapist competent in delivering pre-operative education, depending on staffing availability. Patients recruited and consented on the ward the day prior to their surgery that are unavailable for education before 4pm will be seen by the evening shift physiotherapist, time permitting.
As participants may be recruited in either pre-admission clinic, or on a surgical ward prior to their surgery, participants will be receiving pre-operative education at differing time points prior to their surgery and in various environments. Additionally, physiotherapists of varying experience levels will be providing this education. A record of the location, timing and experience level of the staff member delivering the pre-operative education will be kept.
The face-to-face education session is a one-off session of approximately 15 minutes conducted by a physiotherapist. This will reflect current practice and include a brief subjective assessment of the patient including: respiratory/ cardiac history, smoking history, presence of a productive cough, and current level of function. Education provided will include information on the importance of commencing deep breathing exercises post-operatively (with or without an incentive spirometer) and encouraging patients to do 10 deep breaths every hour (when awake), followed by a supported cough (with a towel or self-hug). Deep breathing exercises will be practiced with an incentive spirometer for a minimum of 5 repetitions and continue until appropriate technique is demonstrated by the patient including an inspiratory hold, with a maximum of 2 sets of 10 repetitions. Patients will be educated on circulation exercises to commence immediately following surgery, as well as the importance of early mobility, and informed that a physiotherapist will assist them with mobilising on the first day after having surgery. Any questions that the participant may have will also be answered during this session.
Adherence to this intervention will be monitored as for the digital video group, via semi-scripted interviews on day 3-5 post-operatively and will include questions to check participant recall of receiving intervention as well as recall of content. Additionally, reflecting current practice, the ward physiotherapist will complete a sticker and place this in the patient chart as documentation of the subjective assessment and completion of education.
Control group
Active

Outcomes
Primary outcome [1] 334179 0
Protocol fidelity: percentage of patients in each group that accurately recall watching the video or getting face-to-face education. This will be assessed via the semi-scripted interviews conducted post-operatively.
Timepoint [1] 334179 0
Day 3-5 post-operatively.
Primary outcome [2] 334180 0
Treatment fidelity: Recall of educational information based on semi-scripted patient interviews (modified from study by Ianthe Boden) and scored using scoring schema (modified from study by Ianthe Boden). Interviews are expected to take approximately 15 minutes and will be conducted by members of the research. The interviews will be audio-recorded and later transcribed a member of the research team.
Timepoint [2] 334180 0
Day 3-5 post-operatively.
Primary outcome [3] 334181 0
Acceptability: pre- and post-operative questionnaire asking patients to rate their preferred delivery method for education (designed for this study).
Timepoint [3] 334181 0
Pre-operative: At time of recruitment/ consent (before education option known to participants).
Post-operative: D3-5 post-operatively.
Secondary outcome [1] 419698 0
Recruitment: percentage of all eligible patients recruited to participate in the study using approved consent methods.
Timepoint [1] 419698 0
At recruitment, collated at end of study based on screening log.
Secondary outcome [2] 419699 0
Retention: percentage of patients withdrawing consent. This will assessed using the study screening log and participant records.
Timepoint [2] 419699 0
At completion of study.
Secondary outcome [3] 419700 0
Missing data: percentage of primary and secondary outcome data unable to be collected. This will be assessed by reviewing the study database.
Timepoint [3] 419700 0
At conclusion of study.
Secondary outcome [4] 419701 0
Incidence of post-operative pulmonary complications (PPC’s) post-operatively: using Melbourne Group Scale (MGS) version 2
Timepoint [4] 419701 0
Participants will be assessed daily from day 1 to day 7 post-operatively, and thereafter only if clinical suspicion of PPC based on respiratory deterioration until day 14.
Secondary outcome [5] 419702 0
Hospital length of stay (days) including inpatient sub-acute rehabilitation. This data will be gathered from patient medical records and use of 'the Viewer' to view patient hospital encounters.
Timepoint [5] 419702 0
Recorded at patient discharge from hospital.
Secondary outcome [6] 419703 0
Time to physiotherapy discharge in days post-operatively (discharge as per usual criteria including when patients reach previous level of function and are able to manage effective airway clearance independently.) This will be assessed based on medical chart reviews.
Timepoint [6] 419703 0
Recorded at patient discharge from physiotherapy service.
Secondary outcome [7] 420004 0
Number of physiotherapy interventions post-surgery. Assessed based on ward physiotherapist documentation of interventions in medical chart.
Timepoint [7] 420004 0
Review of patient medical chart will occur on discharge from physiotherapy service.
Secondary outcome [8] 420005 0
Time spent with patients pre-surgery. This will be assessed based on ward physiotherapists recording time spent with patients on each review on data collection forms.
Timepoint [8] 420005 0
Review and collation of data collection forms will occur on patient discharge from physiotherapy service.
Secondary outcome [9] 420006 0
Time spent with patients post-surgery. This will be assessed based on ward physiotherapists recording time spent with patients during pre-operative assessment for group 1 and any time spent answering questions for group 2 participants. Time will be recorded on data collection forms.
Timepoint [9] 420006 0
Review and collation of data collection forms will occur on patient discharge from physiotherapy service.

Eligibility
Key inclusion criteria
Eligible participants are people undergoing major thoracic surgery via thoracotomy or Video-assisted thoracoscopic surgery (VATS) at TPCH.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the trial if they meet any of the following exclusion criteria:
• Insufficient English to understand verbal education and/or complete evaluation
• Cognitive issues which may inhibit comprehension/completion of evaluation (e.g. severe dementia as documented in medical chart and impeding ability of patient to provide informed consent)
• Patients with visual / hearing impairment preventing them from hearing verbal education or visualising digital video screen
• Emergency surgery or out of hours patient arrival which precludes consenting and delivery of randomly allocated education

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation): A random number generator will be used to determine the allocation sequence of participants into either Group 1 (face-to-face education) or Group 2 (digital video education).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A minimum sample size of 60 participants (30 per group) has been selected for this pilot trial. This will be sufficient to provide estimates for feasibility outcomes and effect size estimates that will be used to inform sample size calculations for a future study.

Data will be uploaded to Excel for cleaning and exported to a statistical software package for analysis. The characteristics of the sample will be described using summary statistics. Continuous variables will be summarised as mean (SD) or median (IQR) as appropriate and categorical variables will be summarised as frequency (percentage). Baseline patient characteristics will be compared between groups using t-tests, non-parametric tests for continuous variables and Chi-square or Fisher’s exact tests for categorical variables as appropriate. Outcome measures for each group will be reported with 95% confidence intervals. Difference in incidence of PPCs between groups will be tested using Fisher’s exact test. Transcribed interviews will be scored using the ‘interview scoring schema’.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
20/11/2023
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
5/08/2024
Actual
Sample size
Target
60
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24301 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 39848 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 313413 0
Charities/Societies/Foundations
Name [1] 313413 0
The Common Good Foundation
Country [1] 313413 0
Australia
Primary sponsor type
Individual
Name
Jessica King
Address
The Prince Charles Hospital, Rode Rd, Chermside, QLD, 4032
Country
Australia
Secondary sponsor category [1] 315179 0
Hospital
Name [1] 315179 0
The Prince Charles Hospital
Address [1] 315179 0
The Prince Charles Hospital, Rode Rd, Chermside, QLD, 4032
Country [1] 315179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312629 0
Metro North Health HREC B
Ethics committee address [1] 312629 0
The Prince Charles Hospital, Rode Rd, Chermside, QLD, 4032.
Ethics committee country [1] 312629 0
Australia
Date submitted for ethics approval [1] 312629 0
01/03/2023
Approval date [1] 312629 0
11/04/2023
Ethics approval number [1] 312629 0
HREC/2023/MNHB/90738

Summary
Brief summary
The objectives of this feasibility pilot study are to investigate whether pre-operative physiotherapy education delivered via digital video has similar acceptability and treatment fidelity as face-to-face pre-operative education and to pilot the conduct of a randomised controlled trial comparing these two modalities. This study will provide preliminary data to guide the design of a more definite study evaluating the clinical effectiveness of digital versus face-to-face education.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125342 0
Ms Jessica King
Address 125342 0
The Prince Charles Hospital, Rode Rd, Chermside, QLD 4032
Country 125342 0
Australia
Phone 125342 0
+61 0432846101
Fax 125342 0
Email 125342 0
jessica.king3@health.qld.gov.au
Contact person for public queries
Name 125343 0
Ms Jessica King
Address 125343 0
The Prince Charles Hospital, Rode Rd, Chermside, QLD 4032
Country 125343 0
Australia
Phone 125343 0
+61 0432846101
Fax 125343 0
Email 125343 0
jessica.king3@health.qld.gov.au
Contact person for scientific queries
Name 125344 0
Ms Jessica King
Address 125344 0
The Prince Charles Hospital, Rode Rd, Chermside, QLD 4032
Country 125344 0
Australia
Phone 125344 0
+61 0432846101
Fax 125344 0
Email 125344 0
jessica.king3@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be retained by the principal investigator and utilised only for related studies in the future whilst adhering to ethical procedures and data storage guidelines.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.