Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000298819
Ethics application status
Approved
Date submitted
8/01/2021
Date registered
18/03/2021
Date last updated
28/01/2024
Date data sharing statement initially provided
18/03/2021
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, applying the “AusPROM Recommendations”
Scientific title
Patient reported outcome measure (PROM) implementation for elective surgery patients in Australia, applying the “AusPROM Recommendations”
Secondary ID [1] 303100 0
Nil Known
Universal Trial Number (UTN)
U1111-1263-4757
Trial acronym
AusPROM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients following elective surgery in the private healthcare setting 320189 0
Condition category
Condition code
Surgery 318136 318136 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
* 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 and another 2-3 minutes for additional questions on surveys for the pilot sites). 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.

* Exposure: elective surgery

* Barriers and enablers will be from the staff perspective. To obtain the staff perspective the Delphi technique will be utilised with health professional staff. This will involve three separate 1 hour focus groups (via videoconference) where barriers and enablers are discussed, and a consensus process is used to establish the AusPROM implementation recommendations.

To develop the set of “AusPROM” implementation recommendations, data from Phase I and II will be combined. This will see data from Phase I influencing Phase II, and likewise, data from Phase II will influence the latter stages of Phase I. Phase I and Phase II will run in parallel and will occur over a 12 month duration (Phase I over the full 12 months and Phase II over the first 8 months of this period). They are detailed below:

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.

SEQUENCE OF EVENTS:

a) Patients (part of Phase II): Pre-testing at one site over six weeks; within a month of this concluding this will be followed by:
b) Staff (part of Phase I): Focus group 1 (1 hour duration via video conference); within a month this will be followed by:
c) Patients (part of Phase II): Piloting at 4 sites over 3 months; within a month of this concluding this will be followed by:
d) Staff (part of Phase I): Focus group 2 (1 hour duration via video conference); within a month this will be followed by:
e) Patients (part of Phase III): Implementation across all 30 sites over 3 months (Phase III is NOT a part of this current trial registration process as it will be registered on the ANZCTR separately - this is just noted to give context to the sequence of events); within a month of this concluding this will be followed by:
f) Staff (part of Phase I): Focus group 3 (1 hour duration via video conference).
Intervention code [1] 319401 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326460 0
To report the "AusPROM" implementation recommendations based on the barriers and enablers for national ePROM implementation
Timepoint [1] 326460 0
Phase I of the AusPROM recommendations has 12 months as the primary timepoint.

Staff data will be collected at about the 2.5 month, 6.5 month and 10.5 month time points of the 12 months of data collection. Member checking for the focus groups may require staff to verify focus group transcripts hence we are allowing up to 12 months for staff data collection. Specifically:

Staff: Focus group 1 (1 hour duration via video conference); approximately 2.5 months from the start of data collection

Staff : Focus group 2 (1 hour duration via video conference); approximately 6.5 months from the start of data collection

Staff : Focus group 3 (1 hour duration via video conference); approximately 10.5 months from the start of data collection
Secondary outcome [1] 391552 0
To test the 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,

During Phase II across the four pilot hospital sites, the PROM survey will contain the 15 QoR-15 questions as well as two questions on patient acceptability. The first will use a 0-10 Likert scale and the second will be an open-ended question (to be themed via a content analysis using the theoretical framework of acceptability).
Timepoint [1] 391552 0
This data will be collected during the 3 month period of Phase II at the four pilot hospital sites. The two acceptability questions on the PROM survey will be asked in the week prior to surgery, the week following surgery and four weeks following surgery,
Secondary outcome [2] 391553 0
Across one pilot site, test the technical 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 II, the PROM survey will be tested for the following:

PRE-TESTING PERIOD: The pre-testing (n=100) will investigate feasibility from a technical perspective. Technical feasibility testing includes the pulling of survey distribution list reports from hospital administration data, distributing the survey and testing the assumed patient email and /or mobile number capture rate for survey distribution.
Timepoint [2] 391553 0
This data will be collected during the pre-testing period of Phase II at one pilot hospital site. 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 six week period.
Secondary outcome [3] 392910 0
Across four pilot sites, 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 II across the four pilot hospital sites, the PROM survey will be tested for the following:

GO LIVE PERIOD: Feasibility testing includes the survey response rate and completion rate for patients who receive an invitation to participate.
Timepoint [3] 392910 0
This data will be collected during the the 3 month "go live" period of Phase II at the four pilot 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,
Secondary outcome [4] 392911 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 [4] 392911 0
This data will be collected during the 3 month "go live" period of Phase II (four pilot 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

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

STAFF (FOCUS GROUPS)
• Age 18+
• Currently employed at Healthscope and working on one of the four pilot hospitals
• AHPRA registered nurse or doctor
• 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
• Patients with a hip / knee / shoulder replacement
• Death (no further surveys will be sent)
• Not meeting the inclusion criteria

#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 PROMs-ESP study

STAFF (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)
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
Statistical methods / analysis
Phase I: To report the barriers and enablers for implementation of an ePROM the results of the three Delphi focus groups will be themed according to the National Institute of Clinical Studies barriers and enablers framework. This framework includes six levels of potential barriers and enablers including the innovation itself (integrating the ePROM survey into usual care), the professionals / staff, the patient, the social context, the organisation context and the economic and political context. To report the implementation recommendations for the integration of an ePROM into usual care, consensus statements will be drafted in the initial focus group, and re-drafted and refined in the subsequent focus groups.

Phase II: Survey response rate and completion rate 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.

Phase II: Acceptability of the ePROM survey on a 0-10 Likert will be presented as a mean with interquartile ranges. Responses from an open-ended question regarding ePROM survey acceptability 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.

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
30/03/2021
Actual
26/03/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
31/12/2021
Date of last data collection
Anticipated
31/01/2022
Actual
31/01/2022
Sample size
Target
800
Accrual to date
Final
5985
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 18347 0
Norwest Private Hospital - Bella Vista
Recruitment hospital [2] 18348 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 18357 0
Northpark Private Hospital - Bundoora
Recruitment hospital [4] 18367 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 32425 0
2153 - Bella Vista
Recruitment postcode(s) [2] 32426 0
2031 - Randwick
Recruitment postcode(s) [3] 32435 0
3083 - Bundoora
Recruitment postcode(s) [4] 32445 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 307504 0
Hospital
Name [1] 307504 0
Healthscope
Country [1] 307504 0
Australia
Primary sponsor type
Hospital
Name
Healthscope
Address
312 St Kilda Rd,
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 308201 0
None
Name [1] 308201 0
Address [1] 308201 0
Country [1] 308201 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307576 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 307576 0
Plenty Rd &, Kingsbury Dr,
Bundoora
VIC 3086
Ethics committee country [1] 307576 0
Australia
Date submitted for ethics approval [1] 307576 0
10/11/2020
Approval date [1] 307576 0
18/01/2021
Ethics approval number [1] 307576 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) understand barriers and enablers to ePROM implementation across nation-wide hospitals and to develop Australian ePROM implementation recommendations (entitled AusPROM); and (ii) test the feasibility and acceptability of the QoR-15 PROM for elective surgery day and overnight patients applying the early versions of the AusPROM implementation recommendations.

There are two phases of this project. Phase I will identify barriers and facilitators to recommendations for the implementation of the AusPROM using a Delphi technique with health professional staff and will occur alongside Phase II. The Delphi technique will involve three separate 1 hour focus groups (vis videoconference) where barriers and enablers are discussed, and a consensus process is used to establish the AusPROM implementation recommendations. Following the first focus group, early versions of the implementation recommendations will be embedded into Phase II (feasibility testing) to test the implementation recommendations with feedback provided to the subsequent staff focus groups.

Phase II will determine QoR-15 acceptability from an elective surgery patient perspective across 4 pilot hospitals, using the AusPROM implementation recommendations. For Phase II, patients will complete brief surveys, incorporating the QoR-15 and two acceptability questions, in the week prior to surgery, in the week following surgery and 4 weeks post-surgery. The primary endpoint will be 4 weeks post-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) and health professional (Delphi technique) co-design 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 107734 0
Prof Meg Morris
Address 107734 0
La Trobe University
Plenty Rd &, Kingsbury Dr,
Bundoora
VIC 3086
Country 107734 0
Australia
Phone 107734 0
+61 433405662
Fax 107734 0
Email 107734 0
[email protected]
Contact person for public queries
Name 107735 0
Prof Natasha Brusco
Address 107735 0
La Trobe University
Plenty Rd &, Kingsbury Dr,
Bundoora
VIC 3086
Country 107735 0
Australia
Phone 107735 0
+61 408251124
Fax 107735 0
Email 107735 0
[email protected]
Contact person for scientific queries
Name 107736 0
Prof Natasha Brusco
Address 107736 0
La Trobe University
Plenty Rd &, Kingsbury Dr,
Bundoora
VIC 3086
Country 107736 0
Australia
Phone 107736 0
+61 408251124
Fax 107736 0
Email 107736 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.