Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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.
Query!
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).
Query!
Secondary ID [1]
295451
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RTR-III Pilot
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Postoperative Recovery
308706
0
Query!
Postoperative cognitive function
308707
0
Query!
Condition category
Condition code
Anaesthesiology
307646
307646
0
0
Query!
Other anaesthesiology
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
301760
0
Rehabilitation
Query!
Intervention code [2]
301761
0
Behaviour
Query!
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.
Query!
Control group
Active
Query!
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).
Query!
Assessment method [1]
306632
0
Query!
Timepoint [1]
306632
0
Postoperative week 6 (primary timepoint)
Query!
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).
Query!
Assessment method [2]
306688
0
Query!
Timepoint [2]
306688
0
Postoperative day 1, Day 3, Day 7, Week 2 and Week 6
Query!
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.
Query!
Assessment method [1]
349065
0
Query!
Timepoint [1]
349065
0
Postoperative day 1, 3, 7 and 14, postoperative week 6 and postoperative month 3.
Query!
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. .
Query!
Assessment method [2]
349067
0
Query!
Timepoint [2]
349067
0
Postoperative day 1, 3, 7 and 14, postoperative week 6 and postoperative month 3.
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Cardiac surgery or cranial neurosurgery.
Dementia, intellectual disability or
Anticipation of patient death within six weeks of index surgery.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
3/09/2018
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
3/06/2019
Query!
Actual
Query!
Date of last data collection
Anticipated
3/09/2019
Query!
Actual
Query!
Sample size
Target
150
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
11326
0
Royal Melbourne Hospital - City campus - Parkville
Query!
Recruitment hospital [2]
11327
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment postcode(s) [1]
23223
0
3052 - Parkville
Query!
Recruitment postcode(s) [2]
23224
0
3000 - Melbourne
Query!
Recruitment outside Australia
Country [1]
10624
0
United States of America
Query!
State/province [1]
10624
0
Ohio
Query!
Funding & Sponsors
Funding source category [1]
300042
0
University
Query!
Name [1]
300042
0
University of Melbourne
Query!
Address [1]
300042
0
Ultrasound Education Group,
Department of Surgery,
University of Melboourne,
Grattan St, Parkville, Vic, 3052, AUSTRALIA
Query!
Country [1]
300042
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Melbourne Health
Query!
Address
University of Melbourne
Grattan St
Parkville, Vic 3052
Query!
Country
Australia
Query!
Secondary sponsor category [1]
299433
0
None
Query!
Name [1]
299433
0
Query!
Address [1]
299433
0
Query!
Country [1]
299433
0
Query!
Ethics approval
Ethics application status
Submitted, not yet approved
Query!
Ethics committee name [1]
300889
0
Melbourne Health Human Research Ethics Committee (EC00243)
Query!
Ethics committee address [1]
300889
0
Royal Melbourne Hospital
Grattan St,
Parkville, 3052, Vic
Query!
Ethics committee country [1]
300889
0
Australia
Query!
Date submitted for ethics approval [1]
300889
0
25/06/2018
Query!
Approval date [1]
300889
0
Query!
Ethics approval number [1]
300889
0
Query!
Summary
Brief summary
Engaging patients in their own recovery after surgery is gaining momentum. A pilot study revealed that participants that received real-time recovery feedback (as a method of patient engagement) had better overall recovery at six weeks after surgery.
Health-care providers must also kept informed of each individual patient’s recovery journey, as this alerts them to the patient with suboptimal recovery at the time that it is occurring, which may ultimately improve patient recovery in addition to what occurs when patients alone are informed.
We will conduct a pilot trial investigating whether keeping both patients and their treating teams updated as to each patient’s recovery improve ultimate patient outcome. Recovery will be measured by the Postoperative Quality of Recovery Score (PostopQRS). Patients will be randomised to either receive no real-time feedback on their recovery assessment, or for there to be feedback to both patient and their treating health care team.
This trial will determine the feasibility of providing both patients and their health teams with recovery data at the time of assessment, and will form the basis of a larger trial assessing the impact of each on the quality of a patient’s recovery journey.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
85170
0
Prof Colin Royse
Query!
Address
85170
0
Ultrasound Education Group,
Level 6, Clinical Medical Research Building
The Royal Melbourne Hospital
Grattan St
Parkville, 3052, VIC
Query!
Country
85170
0
Australia
Query!
Phone
85170
0
+613 8344 5673
Query!
Fax
85170
0
Query!
Email
85170
0
[email protected]
Query!
Contact person for public queries
Name
85171
0
Dr Andrea Bowyer
Query!
Address
85171
0
Ultrasound Education Group,
Level 6, Clinical Medical Research Building
The Royal Melbourne Hospital
Grattan St
Parkville, 3052, VIC
Query!
Country
85171
0
Australia
Query!
Phone
85171
0
+613 8344 5673
Query!
Fax
85171
0
Query!
Email
85171
0
[email protected]
Query!
Contact person for scientific queries
Name
85172
0
Dr Andrea Bowyer
Query!
Address
85172
0
Ultrasound Education Group,
Level 6, Clinical Medical Research Building
The Royal Melbourne Hospital
Grattan St
Parkville, 3052, VIC
Query!
Country
85172
0
Australia
Query!
Phone
85172
0
+613 8344 5673
Query!
Fax
85172
0
Query!
Email
85172
0
[email protected]
Query!
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
No additional documents have been identified.
Download to PDF