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PROM implementation for elective surgery patients in Australia, applying the “AusPROM Recommendations”

Patient reported outcome measure (PROM) implementation for elective surgery patients in Australia, applying the “AusPROM Recommendations”

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000298819
Acronym
AusPROM
Enrollment
5985
Registered
2021-03-18
Start date
2021-03-26
Completion date
2021-12-31
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

* 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 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).

Sponsors

Healthscope
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026