Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000609459
Ethics application status
Approved
Date submitted
1/05/2016
Date registered
10/05/2016
Date last updated
15/03/2019
Date data sharing statement initially provided
15/03/2019
Date results provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Post discharge opioid use in surgical patients
Scientific title
Post discharge opioid use in surgical patients
Secondary ID [1] 289114 0
Nil Known
Universal Trial Number (UTN)
The Universal Trial Number (UTN) is U1111-1182-4697
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgery 298583 0
Pain 298584 0
Condition category
Condition code
Anaesthesiology 298660 298660 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who undergo surgery (admission 1 night or greater) and are discharged with prescription opioid medication will be followed up by phone at 2 weeks post hospital discharge. This follow up will determine if opioid therapy has ceased and the handling of opioids post hospital discharge. The phone call will take approximately 10min.
Intervention code [1] 294619 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298155 0
The proportion of surgical patients in the study cohort that have excess opioid medication at 2 weeks post hospital discharge (have ceased therapy and have left over dispensed opioids). This will be determined by what patients report during the phone interview.
Timepoint [1] 298155 0
2 weeks post hospital discharge
Secondary outcome [1] 323307 0
The proportion of admitted surgical patients who receive opioid medication on hospital discharge. This will be determined by review of hospital pharmacy records.
Timepoint [1] 323307 0
Time of hospital discharge
Secondary outcome [2] 323308 0
Description of the post discharge pain experience of surgical patients who received discharge opioid medication after surgical care. This will be determined by what patients report at the phone interview. Specifically whether they have experienced severe pain post hospital discharge and their current pain score (0-10 verbal numerical rating scale)
Timepoint [2] 323308 0
At 2 weeks post hospital discharge
Secondary outcome [3] 323309 0
The proportion of patients still requiring opioid analgesia 2 weeks post hospital discharge. This will be determined by patient self report at phone interview.
Timepoint [3] 323309 0
At 2 weeks post hospital discharge

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Had elective or emergency surgery and admitted for at least one night post-surgery at The Royal Melbourne, Peter MacCallum Cancer Centre, Western Health or The Women’s Hospital
3. Provided with prescription opioids on discharge from a surgical unit at The Royal Melbourne Hospital, Peter MacCallum Cancer Centre, Western Health or The Women’s Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who did not have an operative procedure or discharged on the same day as the surgical procedure
2. Patients not dispensed opioids by pharmacy at a participating health service
3. Language or cognitive barriers to study comprehension, consent and phone follow up
4. Not available for phone interview 2 weeks following hospital discharge

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study will involve a fixed term (8 week) audit period at each of 4 hospitals and a total estimated study cohort of 1500 patients is anticipated. The large sample will allow a comprehensive snapshot of opioid handling post surgical discharge.

The intent of this study is to describe the extent of the community opioid reservoir post hospital discharge for surgical care and as such descriptive statistics (proportions / percentages/means/medians with appropriate measures of variability) will be the main results reported. However, exploratory analysis of predictive factors for ongoing opioid therapy and high pain scores at 2 weeks post surgery and requirement for additional opioid prescription (including age, gender, type of surgery, pain history and opioid therapy at admission) will be performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2017
Actual
14/02/2017
Date of last participant enrolment
Anticipated
31/05/2017
Actual
27/04/2017
Date of last data collection
Anticipated
14/06/2017
Actual
11/05/2017
Sample size
Target
1500
Accrual to date
Final
1450
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5707 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 5708 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [3] 5709 0
Western Hospital - Footscray
Recruitment hospital [4] 5710 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 13195 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 13222 0
3052 - Parkville
Recruitment postcode(s) [3] 13223 0
3002 - East Melbourne
Recruitment postcode(s) [4] 13224 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 293487 0
Hospital
Name [1] 293487 0
Royal Melbourne Hospital
Country [1] 293487 0
Australia
Funding source category [2] 296186 0
Charities/Societies/Foundations
Name [2] 296186 0
Australian and New Zealand College of Anaesthetists
Country [2] 296186 0
Australia
Primary sponsor type
Individual
Name
Megan Allen
Address
Department of anaesthesia and pain management
Royal Melbourne Hospital
Melbourne, VICTORIA, Australia, 3050
Country
Australia
Secondary sponsor category [1] 292311 0
Individual
Name [1] 292311 0
Charles Kim
Address [1] 292311 0
Department of anaesthesia and pain management
Royal Melbourne Hospital
Melbourne, VICTORIA, Australia, 3050
Country [1] 292311 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294931 0
Melbourne Health HREC
Ethics committee address [1] 294931 0
Ethics committee country [1] 294931 0
Australia
Date submitted for ethics approval [1] 294931 0
04/07/2016
Approval date [1] 294931 0
21/09/2016
Ethics approval number [1] 294931 0
LNR/15/MH/252 2015.196

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

Contacts
Principal investigator
Name 65530 0
Dr Megan Allen
Address 65530 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Country 65530 0
Australia
Phone 65530 0
+61 401 053 427
Fax 65530 0
Email 65530 0
[email protected]
Contact person for public queries
Name 65531 0
Megan Allen
Address 65531 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Country 65531 0
Australia
Phone 65531 0
+61 3 9342 7540
Fax 65531 0
Email 65531 0
[email protected]
Contact person for scientific queries
Name 65532 0
Megan Allen
Address 65532 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Country 65532 0
Australia
Phone 65532 0
+61 3 9342 7540
Fax 65532 0
Email 65532 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.