Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001427268p
Ethics application status
Submitted, not yet approved
Date submitted
6/07/2018
Date registered
27/08/2018
Date last updated
27/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does keeping patients and their health care team informed as to the progress of individual patient postoperative recovery improve patient outcome? A Postoperative Quality of Recovery Score (PostopQRS) Pilot study.
Scientific title
A pilot randomised controlled trial to determine group separation and the feasibility of providing real-time recovery feed-back to patients and their health-care providers to improve patient outcome at week 6 as measured by the Postoperative Quality of Recovery Score (PostopQRS).
Secondary ID [1] 295451 0
None
Universal Trial Number (UTN)
Trial acronym
RTR-III Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Recovery 308706 0
Postoperative cognitive function 308707 0
Condition category
Condition code
Anaesthesiology 307646 307646 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Common management principles for all study participants
In keeping with a pragmatic trial design, this clinical trial does not specify any aspect of clinical management for the enrolled patients. Perioperative management (surgical type, anaesthesia and ward management) is to be determined by the treating surgeons, anaesthetists and ward staff. All participants will complete a postoperative recovery assessment questionnaire (the PostopQRS) prior to surgery (within 14 days to determine each patient's baseline function), and then one, three and seven days, two and six weeks after surgery. Further longer-term follow up will occur at three months after surgery to identify if the effects of the intervention persists beyond the intervention period. The researcher at each site will conduct the PostopQRS with the participant and provide feedback on recovery as described below according to allocation. At the conclusion of the PostopQRS survery but prior to feedback to the patient as to their performance, each patient will complete the sleep survery (PROMIS Sleep Deprivation Short Form 8b).

Arm 2: Intervention Group: Real-time feedback to the participant and the healthcare team
At the end of each PostopQRS assessment, both the participant and the nominated member of the treating medical team will be informed as to how each patient performed, compared to each preoperative baseline. This will be the surgical consultant or fellow responsible for the surgery. After hospital discharge, the participants general practitioner will also receive the feedback.
Intervention code [1] 301760 0
Rehabilitation
Intervention code [2] 301761 0
Behaviour
Comparator / control treatment
Arm 1: Control Group: Real-time feedback to the participant
Feedback is given to the participant but not the treating medical staff. This arm is representative of intervention group in the previous real-time recovery pilot that was associated with improved patient outcome.
Control group
Active

Outcomes
Primary outcome [1] 306632 0
The Primary outcome is the group separation (absolute and relative effect size) between the intervention and control groups in terms of the definitive trial’s study outcome (incidence of overall recovery in all domains of the PostopQRS).
Timepoint [1] 306632 0
Postoperative week 6 (primary timepoint)
Primary outcome [2] 306688 0
Group separation (absolute and relative effect size) between the intervention and control groups in terms of the definitive trial’s study outcome (incidence of overall recovery in all domains of the PostopQRS).
Timepoint [2] 306688 0
Postoperative day 1, Day 3, Day 7, Week 2 and Week 6
Secondary outcome [1] 349065 0
Feasibility of providing patient +/- treating medical team with real-time individualised patient recovery data - recruitment rate, patient follow-up and participant satisfaction ( as measured by the PostopQRS) with the intervention.
Timepoint [1] 349065 0
Postoperative day 1, 3, 7 and 14, postoperative week 6 and postoperative month 3.
Secondary outcome [2] 349067 0
The Incidence of poor sleep quality, both preoperatively and postoperatively, as measured by the PROMIS Sleep Deprivation Short Form 8b. .
Timepoint [2] 349067 0
Postoperative day 1, 3, 7 and 14, postoperative week 6 and postoperative month 3.

Eligibility
Key inclusion criteria
Adult participants undergoing major elective surgery
-Modified Johns Hopkins scale >2 AND
greater than two hours duration,
Sufficient English to complete the PostopQRS.
Surgery type - include abdominal, thoracic, joint replacement and cancer surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac surgery or cranial neurosurgery.
Dementia, intellectual disability or
Anticipation of patient death within six weeks of index surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be concealed by the web-based enrolment system. The site research staff will recruit patients and conduct the PostopQRS survey prior to surgery. Allocation will occur after surgery. Follow up conduct of the PostopQRS survey will be performed face-to-face while the participant is in hospital and via telephone after hospital discharge.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation codes will be in uneven blocks using a web-based automatic enrolment system at participating institutions to facilitate recruitment across different time zones and out-of-hours cases. The randomisation sequence will be generated using a computer random sequence generator for each strata of uneven blocks to ensure close balance of the numbers in each group at any one time point during the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A preliminary sample size estimate of a fully powered study was based on the recovery data from the feasibility pilot study and on a study power of 90% and a two-sided 0.050 level of significance. In the Pilot RTR-PostopQRS study, the incidence of overall recovery at week six was 54% in the group of patients which received real-time recovery feedback, compared to 29% in the group of patients which did not. Assuming a relative effect size of 30%, that is, 38% recovery compared to 29% recovery, 428 patients would be required per study group. To allow for a 2% in-study attrition, the sample size would be increased to 440 participants per group. This pilot study is thus based on 100 patients in total (50 patients per group), which is >20% of the total study population of the definitive trial. This equates to 33 patients per trial site.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
3/06/2019
Actual
Date of last data collection
Anticipated
3/09/2019
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11326 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 11327 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 23223 0
3052 - Parkville
Recruitment postcode(s) [2] 23224 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 10624 0
United States of America
State/province [1] 10624 0
Ohio

Funding & Sponsors
Funding source category [1] 300042 0
University
Name [1] 300042 0
University of Melbourne
Country [1] 300042 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
University of Melbourne
Grattan St
Parkville, Vic 3052
Country
Australia
Secondary sponsor category [1] 299433 0
None
Name [1] 299433 0
Address [1] 299433 0
Country [1] 299433 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300889 0
Melbourne Health Human Research Ethics Committee (EC00243)
Ethics committee address [1] 300889 0
Ethics committee country [1] 300889 0
Australia
Date submitted for ethics approval [1] 300889 0
25/06/2018
Approval date [1] 300889 0
Ethics approval number [1] 300889 0

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

Contacts
Principal investigator
Name 85170 0
Prof Colin Royse
Address 85170 0
Ultrasound Education Group,
Level 6, Clinical Medical Research Building
The Royal Melbourne Hospital
Grattan St
Parkville, 3052, VIC
Country 85170 0
Australia
Phone 85170 0
+613 8344 5673
Fax 85170 0
Email 85170 0
colin.royse@unimelb.edu.au
Contact person for public queries
Name 85171 0
Andrea Bowyer
Address 85171 0
Ultrasound Education Group,
Level 6, Clinical Medical Research Building
The Royal Melbourne Hospital
Grattan St
Parkville, 3052, VIC
Country 85171 0
Australia
Phone 85171 0
+613 8344 5673
Fax 85171 0
Email 85171 0
andrea.bowyer@mh.org.au
Contact person for scientific queries
Name 85172 0
Andrea Bowyer
Address 85172 0
Ultrasound Education Group,
Level 6, Clinical Medical Research Building
The Royal Melbourne Hospital
Grattan St
Parkville, 3052, VIC
Country 85172 0
Australia
Phone 85172 0
+613 8344 5673
Fax 85172 0
Email 85172 0
andrea.bowyer@mh.org.au

No information has been provided regarding IPD availability


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
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