Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000882921
Ethics application status
Approved
Date submitted
13/07/2020
Date registered
4/09/2020
Date last updated
4/09/2020
Date data sharing statement initially provided
4/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study of discharge analgesia and analgesic outcomes after discharge following surgery in Southern Adelaide Local Health Network: A prospective pilot study
Scientific title
Observational study investigating appropriateness of discharge analgesia prescribing and analgesic outcomes in elective and emergency surgical patients after discharge in Southern Adelaide Local Health Network: A prospective pilot study
Secondary ID [1] 301752 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 318210 0
Condition category
Condition code
Anaesthesiology 316217 316217 0 0
Pain management
Surgery 316561 316561 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A non-interventional, prospective observational cohort study with post-hoc survey will be undertaken.

Participants will be recruited from patients undergoing surgery at Flinders Medical Centre and Noarlunga Health Service and will be surveyed on analgesia usage and outcome at time points of two weeks and six months post discharge. Participants will also be surveyed on analgesia education received prior to discharge, which is incorporated into the follow up survey at two weeks post discharge. As no appropriate validated survey was available to capture the outcomes of interest, surveys were designed specifically for this study. Both surveys should take participants less then 5 minutes to complete.
Intervention code [1] 318048 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324405 0
Volume of opioid analgesia prescribed on discharge, assessed via review of patient medical record.
Timepoint [1] 324405 0
At time of discharge.
Primary outcome [2] 324408 0
Volume of opioid analgesia from discharge prescription consumed, assessed via study-specific survey.
Timepoint [2] 324408 0
Assessed at two weeks and six months post discharge.
Primary outcome [3] 324689 0
Incidence of analgesia failure, defined as representation to an emergency department due to pain or as a participant who exhausted analgesia and remained in pain limiting function but was unable to access health care, assessed via study-specific survey.
Timepoint [3] 324689 0
Assessed at two weeks post discharge.
Secondary outcome [1] 384565 0
Conversion to chronic opioid use post discharge, assessed via study-specific survey
Timepoint [1] 384565 0
Assessed at six months post-discharge
Secondary outcome [2] 384566 0
Recall of analgesia education, assessed via study-specific survey
Timepoint [2] 384566 0
Assessed at two weeks post-discharge

Eligibility
Key inclusion criteria
- Undergoing elective or emergency surgery at Flinders Medical Centre or Noarlunga Health Service.
- Aged 18 years or greater at time of consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to provide informed consent for self (as per consent to surgery).
- Self identifies as being unable to complete an online survey on their smart phone.
- Non-English speaking.
- Declines participation.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to define initial participant responses.

A model will be developed to explore the relationship between volume prescribed, volume consumed and episodes of analgesia failure via simple plotting on X-Y axis. Scenarios will then be modelled on expected outcomes if volume of prescribed opioid is reduced by different rates (e.g. 10%, 20%, 50%). Confidence intervals will be developed for each scenario via bootstrapping, with Poisson regression applied.

Statistical advice has indicated that a minimum of 20 episodes of analgesia inadequacy would be required in order to effectively perform the proposed modelling. The research team has been unable to identify any previously published data on the incidence of analgesia inadequacy. Expert opinion was sort from the acute pain service at both SALHN and CALHN and the consensus was that the current rate of analgesia inadequacy is likely to be very low, however neither service had previously investigated this outcome.

For this reason, a pilot study design is proposed with an initial three month trial period of data collection. A power analysis will then be undertaken for a planned subsequent full study. It is anticipated that approximately 400 potential participants would be approach in the pilot study over a three month period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2020
Actual
Date of last participant enrolment
Anticipated
29/10/2020
Actual
Date of last data collection
Anticipated
15/04/2022
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17065 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 17066 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 30738 0
5042 - Bedford Park
Recruitment postcode(s) [2] 30739 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 306193 0
Hospital
Name [1] 306193 0
Flinders Medical Centre - Department of Anaesthesia
Country [1] 306193 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre - Department of Anaesthesia
Address
Flinders Dr, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 306666 0
None
Name [1] 306666 0
Address [1] 306666 0
Country [1] 306666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306396 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 306396 0
Ethics committee country [1] 306396 0
Australia
Date submitted for ethics approval [1] 306396 0
28/11/2019
Approval date [1] 306396 0
28/02/2020
Ethics approval number [1] 306396 0
HREC/19/SAC/314

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

Contacts
Principal investigator
Name 103738 0
Dr Jason Koerber
Address 103738 0
Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 103738 0
Australia
Phone 103738 0
+61882045511
Fax 103738 0
Email 103738 0
[email protected]
Contact person for public queries
Name 103739 0
Damien Kearney
Address 103739 0
Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 103739 0
Australia
Phone 103739 0
+61 429969681
Fax 103739 0
Email 103739 0
[email protected]
Contact person for scientific queries
Name 103740 0
Damien Kearney
Address 103740 0
Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 103740 0
Australia
Phone 103740 0
+61 429969681
Fax 103740 0
Email 103740 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
As per ethics approval


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.