Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000969864
Ethics application status
Approved
Date submitted
9/06/2021
Date registered
26/07/2021
Date last updated
28/01/2024
Date data sharing statement initially provided
26/07/2021
Date results information initially provided
28/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
PROM implementation for elective surgery patients in Australia: national implementation of the “AusPROM Recommendations” (Phase III)
Scientific title
Patient reported outcome measure (PROM) implementation for elective surgery patients in Australia, applying the “AusPROM Recommendations” throughout Australia (PHASE III)
Secondary ID [1] 304260 0
None
Universal Trial Number (UTN)
U1111-1263-4757
Trial acronym
AusPROM (AUStralian Patient Reported Outcome Measures implementation recommendations)
Linked study record
The current study is linked to ACTRN12621000298819.

Trial ACTRN12621000298819 is the pilot work which will directly impact and guide the current study, meaning that the current study is a direct follow-up of trial ACTRN12621000298819.

Health condition
Health condition(s) or problem(s) studied:
Patients following elective surgery in the private healthcare setting across Australia 321980 0
Condition category
Condition code
Surgery 319701 319701 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NOTE: This registration record refers to Phase III of a broader study.

Phase I and II are reported as part of trial registration number ACTRN12621000298819. In summary, PHASE I: Development of the "AusPROM" implementation recommendations. Phase I is an iterative process and it extends the duration of the 12 month study. Phase I informs, and is informed by, Phase II. Informing the "AusPROM" implementation recommendations is a co-design process involving medical and nursing staff (3 focus groups of 1 hour duration via video conference over 12 months). PHASE II: Feasibility testing phase. Phase II involves: (i) pre-testing the survey at 1 pilot site (n=100) for technical feasibility, and (ii) testing the survey at 4 pilot sites across 3 states of Australia (n=800) for response rate feasibility and patient acceptability and this is informed by focus group 1. Phase II will adopt the early recommendations which come from Phase I as will collect patient acceptability feedback and this will further inform the "AusPROM" implementation recommendations.

PHASE III (the current study): Involves the implementation of the PROM across 29 private hospitals Australia-wide. The AusPROM recommendations developed during Phase I and II will guide the Phase III national implementation process.

* The PROM being used for data collection is the Quality of Recovery 15 item tool (QoR-15). The QoR-15 PROM is a 15 item short-form and it was based on the 40 item QoR-40. The QoR-15 has 15 items each rated on a 11-point scale from 0-10, with a maximum score of 150. It takes 2.4 minutes to complete and has reported good validity, reliability and responsiveness. There is evidence that the QoR-15 can be used from pre-surgery up to 24 hours to 7 days post-surgery, as a measure of change over time. The minimal clinical important difference of the QoR-15 is 8.0.

* The PROM will be collected electronically. An email or text will be sent to the patient with a link to a survey containing the QoR-15 questions. It is expected that the survey will take up to 5 minutes to complete (2.4 minutes for the QoR-15 questions). Four of the 29 sites have been pre-selected to also completed the EQ-5D-5L following the PROM questions, to test concurrent validity between the two tools (additional 2-3 minutes to complete the EQ-5D-5L). The PROM data is collected independently of any other hospital data or health professional clinical assessments.

* Observation: Pre and post surgery PROMs. PROMs are observed at three timepoints - the week prior to surgery, the week following surgery and four weeks following surgery. The PROM will be collected electronically from all participating sites over a 3 month period.

* Patients / consumers will also be invited to attend a focus group to provide feedback on the PROMS tool. This will be a once off focus group up to 1 hour duration via video/tele-conference, and will include 6-10 participants.

* Exposure: elective surgery
Intervention code [1] 320597 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327581 0
Across the 29 hospitals, test the feasibility of implementing the QoR-15 PROM for elective surgery day and overnight patients in the week prior to surgery, the week following surgery and four weeks following surgery. During Phase III, across the 29 included hospital sites, the PROM survey will be tested for the survey response rate and completion rate for patients who receive an invitation to participate.
Timepoint [1] 327581 0
This data will be collected during the 3 month "go live" period of Phase III at the 29 hospital sites. Feasibility of the PROM survey will be investigated for the week prior to surgery, the week following surgery and four weeks following surgery, over a three month period in 2021,
Secondary outcome [1] 395721 0
To test PATIENT ACCEPTABILITY of the QoR-15 PROM for elective surgery day and overnight patients in the week prior to surgery, the week following surgery and four weeks following surgery, patients / consumers will be invited to participate in a FOCUS GROUP to discuss patient acceptability of the PROM survey. This will be themed via a content analysis using the theoretical framework of acceptability. This will be a once off focus group up to 1 hour duration via video/tele-conference, and will include 6-10 participants.
Timepoint [1] 395721 0
This data will be collected during the 3 month data collection period of Phase III.
Secondary outcome [2] 395722 0
Concurrent validity between the QoR-15 PROM and the EQ-5D-5L. A Spearman’s correlation coefficient will be used to establish concurrent validity, as the data is not expected to be normally distributed. A correlation coefficient of less than 0.3 will be considered weak, between 0.3 and 0.5 will be considered moderate, and above 0.5 will be considered strong.
Timepoint [2] 395722 0
This data will be collected during the 3 month "go live" period of Phase III at 4 pre-selected hospital sites. Concurrent validity between the QoR-15 and the EQ-5D-5L will be investigated via survey for the week prior to surgery, the week following surgery and four weeks following surgery, over a three month period.
Secondary outcome [3] 395723 0
The percentage of patients who return to pre-surgery status (as measured on the QoR-15) in the week following surgery and at four weeks following surgery
Timepoint [3] 395723 0
This data will be collected during the 3 month "go live" period of Phase III (29 hospital sites). Response scores for the QoR-15 will be reported over the three time points as a change score and as a percentage of participants who return to pre-surgical status the week following surgery and at four weeks following surgery
Secondary outcome [4] 398703 0
EQ-5D-5L quality of life
Timepoint [4] 398703 0
This data will be collected during the 3 month "go live" period of Phase III at 4 pre-selected hospital sites. The EQ-5D-5L will be collected via survey for the week prior to surgery, the week following surgery and four weeks following surgery, over a three month period.

Eligibility
Key inclusion criteria
PATIENTS (SURVEYS)
• Admission one of the 29 Healthscope hospitals in Australia
• Age 18+
• Planned elective surgery
• Provided Healthscope with a valid email address and / or mobile phone number
• Adequate English (captured as “Interpreter = No” on the admission paperwork)
• Consent to participation

PATIENT / CONSUMER (FOCUS GROUPS)
• Age 18+
• Currently employed or volunteering as a consumer representative at Healthscope and providing consumer representative duties at one of the 29 hospital sites
• Consent to participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
PATIENTS (SURVEYS)
• Ticking the “opt out” box on the hospital admission paperwork for participation in patient surveys#
• Pregnant women being admitted for obstetric procedures
• Death (no further surveys will be sent)
• Not meeting the inclusion criteria
• Patients with a hip / knee / shoulder replacement

#On admission to Healthscope, patients are asked on their admission paperwork to "Please tick if you do not wish to receive a patient satisfaction survey". This "opt out" tick box is consistently used across Healthscope as an initial screen for inviting patients (or not) to participate in patient surveys, and this will be applied to this PROM study

PATIENT (FOCUS GROUPS)
• Not meeting the inclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Survey response rates and completion rates will be reported as a number and percentage of the total. Response scores for the QoR-15 will be reported over the three time points as a change score and as a percentage of participants who return to pre-surgical status at 4-weeks post-surgery. This will include (a) a comparison between all surveys at baseline, within 1 week post-surgery and at 4 weeks post-surgery; and (b) only include patients who have completed all three surveys (captured through a unique survey identified which will link multiple surveys completed by the same patient). Missing data shall be in reference to a patient missing one or more of the three surveys. There will be no imputation of missing data. We shall also perform an analysis whereby we stratify the PROM results for different hospitals, different surgical groups and according to age. This will enable us to compare our results with global reports on surgical PROM outcomes for different patient groups.

Acceptability of the PROM survey from the focus group will be themed via a content analysis using the theoretical framework of acceptability (TFA). There will also be a content analysis where the frequency of themes is reported for each of the TFA domains.

To establish if the condition specific QoR-15 PROM has concurrent validity with the generic EQ-5D-5L multi-attribute quality of life measure, data from the four hospital sites during the Phase III will be analysed. We will assess the concurrent validity between the tests, on the basis of Spearman’s correlation coefficients, as the data is not expected to be normally distributed. A correlation coefficient of less than 0.3 will be considered weak, between 0.3 and 0.5 will be considered moderate, and above 0.5 will be considered strong (Akoglu 2018).

Statistical significance is defined as p<0.05 and analyses will be completed on IBM SPSS Version 25.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2021
Actual
1/09/2021
Date of last participant enrolment
Anticipated
30/11/2021
Actual
30/11/2021
Date of last data collection
Anticipated
31/12/2021
Actual
31/12/2021
Sample size
Target
4000
Accrual to date
Final
4176
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308639 0
Hospital
Name [1] 308639 0
Healthscope
Country [1] 308639 0
Australia
Primary sponsor type
Hospital
Name
Healthscope
Address
312 St Kilda Rd,
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 309510 0
None
Name [1] 309510 0
Address [1] 309510 0
Country [1] 309510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308565 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 308565 0
Plenty Rd &, Kingsbury Dr,
Bundoora
VIC 3086
Ethics committee country [1] 308565 0
Australia
Date submitted for ethics approval [1] 308565 0
10/11/2020
Approval date [1] 308565 0
18/01/2021
Ethics approval number [1] 308565 0
HEC20479

Summary
Brief summary
Incorporating patient reported outcome measures (PROMs) into usual care in hospitals can improve safety, quality and patient satisfaction.

The aims of this clinical trial are to: (i) test the feasibility of national implementation of the QoR-15 PROM for elective surgery; (ii) test the patient acceptability of the QoR-15 PROM for elective surgery day and overnight patients, (iii) establish if the QoR-15 PROM has concurrent validity with the EQ-5D-5L, and (iv) report the percentage of patients who return to pre-surgery status (as measured on the QoR-15) in the week following surgery and at four weeks following surgery.

The trial protocol has adopted the Guidelines for Inclusion of Patient Reported Outcomes in Clinical Trials Protocols (SPIRIT-PRO).

The findings will highlight value of patient (acceptability domains) feedback to inform the AusPROM recommendations for the implementation of patient focused outcome measures. The trial will also illuminate the feasibility and value of using the QoR-15 to understand patient views about elective surgery outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111158 0
Prof Meg Morris
Address 111158 0
La Trobe University
Plenty Rd &, Kingsbury Dr,
Bundoora
VIC 3086
Country 111158 0
Australia
Phone 111158 0
+61 433405662
Fax 111158 0
Email 111158 0
[email protected]
Contact person for public queries
Name 111159 0
Prof Natasha Brusco
Address 111159 0
La Trobe University
Plenty Rd &, Kingsbury Dr,
Bundoora
VIC 3086
Country 111159 0
Australia
Phone 111159 0
+61 408251124
Fax 111159 0
Email 111159 0
[email protected]
Contact person for scientific queries
Name 111160 0
Prof Natasha Brusco
Address 111160 0
La Trobe University
Plenty Rd &, Kingsbury Dr,
Bundoora
VIC 3086
Country 111160 0
Australia
Phone 111160 0
+61 408251124
Fax 111160 0
Email 111160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The ultimate goal of patients reporting their PROMs is to enhance care and communication between the medical team and the patient. Asking patients to consent to sharing their individual participant data has the potential to compromise the consent rate and therefore compromise the ultimate goal of enhancing care and communication for this patient population.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.