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
Trial registered on ANZCTR


Registration number
ACTRN12618000876291
Ethics application status
Approved
Date submitted
16/05/2018
Date registered
23/05/2018
Date last updated
25/11/2019
Date data sharing statement initially provided
24/04/2019
Date results information initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of an 'analgesia prescribing' education module for junior doctors and pharmacists: impact on opioid prescribing at discharge
Scientific title
An evaluation of an 'analgesia prescribing' education module for junior doctors and pharmacists: impact on opioid prescribing at discharge
Secondary ID [1] 294899 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management 307860 0
Opioid addiction 307861 0
Condition category
Condition code
Anaesthesiology 306903 306903 0 0
Pain management
Mental Health 306904 306904 0 0
Addiction
Surgery 306905 306905 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-drug trial. The intervention is a one-off pharmacist-led face-to-face education session presented to junior doctors (interns, residents) and clinical pharmacists working on surgical units. This will be a 30 minute 'lecture style' presentation delivered by the Analgesic Stewardship Pharmacist accompanied by Powerpoint slides. The education was developed by the Analgesic Stewardship Pharmacist in collaboration with the organisation's Acute Pain Service and Analgesic Stewardship Committee. The education will be delivered by the Analgesic Stewardship Pharmacist and will take less than one hour. Half of the organisation's surgical units (8/16) have been randomly selected (using a random list generator) to receive the education.

The education session includes information about pain management, analgesia and opioid harms, local and national point-prevalence data on opioid prescribing and mortality, and local and national guidelines for prescribing opioid medications and other analgesics. The session will be delivered within team meetings. No strategies will be used to monitor adherence.
Intervention code [1] 301211 0
Behaviour
Comparator / control treatment
The remaining eight surgical units will receive no education; medical and pharmacy staff working in these units will receive standard education at team meetings.
In addition, the same data collected post-education roll-out will be collected for patients admitted to all sixteen units for the three months prior to the education roll-out.
Control group
Active

Outcomes
Primary outcome [1] 305894 0
Proportion of opioid-naive patients prescribed a regular opioid on discharge from hospital, as identified from hospital discharge summary and/or discharge prescription
Timepoint [1] 305894 0
Discharge from hospital
Secondary outcome [1] 346927 0
Daily morphine oral equivalence (MOE) on discharge from hospital, identified from discharge summary and/or discharge prescription
Timepoint [1] 346927 0
Discharge from hospital
Secondary outcome [2] 346928 0
Proportion of patients prescribed 'as required' opioids on discharge from hospital, identified from discharge summary and/or discharge prescription
Timepoint [2] 346928 0
Discharge from hospital
Secondary outcome [3] 346929 0
Proportion of patients with opioid weaning plans or other communication regarding cessation of opioids, including instructions/communication to the general practitioner on discharge from hospital, identified from discharge summary and/or discharge prescription
Timepoint [3] 346929 0
Discharge from hospital
Secondary outcome [4] 346930 0
Proportion of patients prescribed non-opioid, adjuvant analgesic medications on discharge from hospital, identified from discharge summary and/or discharge prescription
Timepoint [4] 346930 0
Discharge from hospital
Secondary outcome [5] 346931 0
30 day readmission rates, from hospital coding/admission data
Timepoint [5] 346931 0
30 days post discharge from hospital
Secondary outcome [6] 346932 0
Pain score (Numerical Rating Scale) on discharge, collected from inpatient observation charts
Timepoint [6] 346932 0
Discharge from hospital
Secondary outcome [7] 346933 0
Functional Activity Score (FAS) on discharge, identified from inpatient observation charts
Timepoint [7] 346933 0
Discharge from hospital

Eligibility
Key inclusion criteria
Patients:
Admitted to the Alfred Hospital under a surgical unit
Opioid-naive (not prescribed/taking a regular opioid on admission to hospital)
Discharged home (including residential, higher level care)
Length of hospital stay of 24 hours or more

Junior doctors/pharmacists
Interns, residents or clinical pharmacists currently undertaking a rotation with one of the institution's 16 surgical units
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients
Discharged to another acute facility or rehabilitation hospital
Admitted or discharged on opioid replacement therapy

Doctors/pharmacists
None.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Data will be collected for all units for three months before the intervention is rolled out to half of the units. Data will then be collected for all units for a further three months. Due to pre-existing differences between surgical units such as patient acuity or median length of stay which may affect discharge prescribing, outcomes will be compared within units, with the differences pre/post then compared between units/intervention groups.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Local point-prevalence data from the organisation showed that in one week, approximately 200 opioid naive patients were discharged from surgical units; 24% were discharged on a regular opioid medication. To detect an absolute decrease of 5% decrease in regular opioid prescribing in the intervention group, and allowing for a 3% decrease in the control group, with 80% power and alpha of 0.05, 853 opioid naive patients are required in each study arm. Based on discharge rates, six months of recruitment will satisfy this sample size requirement.

Analysis of the primary outcome will consist of proportions and Chi squared tests, with a null hypothesis that there is no difference in proportion of opioid-naive patients receiving regular opioids in the intervention and control groups. Odds ratio and 95% confidence intervals will be presented.

Secondary outcomes will be analysed using chi squared tests and t tests/Mann Whitney U tests where appropriate. Multivariate logistic analysis will be performed to determine the influence of variables such as age, gender, surgery type and time category (elective vs emergency), hospital length of stay and in-hospital referral to Palliative Care/Acute Pain Service.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10897 0
The Alfred - Prahran
Recruitment postcode(s) [1] 22663 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 299481 0
Hospital
Name [1] 299481 0
Alfred Hospital
Address [1] 299481 0
Alfred Hospital
55 Commercial Rd
Melbourne, VIC, 3004
Country [1] 299481 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Alfred Hospital
55 Commercial Rd
Prahran
Victoria
3004
Country
Australia
Secondary sponsor category [1] 298785 0
None
Name [1] 298785 0
Address [1] 298785 0
Country [1] 298785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300388 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 300388 0
Alfred Hospital
55 Commercial Rd
Prahran Victoria 3004
Ethics committee country [1] 300388 0
Australia
Date submitted for ethics approval [1] 300388 0
30/04/2018
Approval date [1] 300388 0
02/05/2018
Ethics approval number [1] 300388 0
226/18

Summary
Brief summary
The misuse of opioids is a major public health issue, and one aspect of concern is the prescribing of opioids after surgery creating new users. Alfred Health's Analgesic Stewardship Committee identified clinician education as a key priority to improve opioid and analgesic prescribing across the organisation. This study will evaluate the impact of a one-off pharmacist-led face-to-face analgesic education session on rates of opioid prescribing at discharge from surgical units.

Eight of sixteen surgical units will be randomised to receive the education intervention, with the other eight serving as a control group; all opioid-naive patients discharged from all surgical units in the three months before and three months after the intervention will be included for analysis. Discharge summaries and prescriptions will be reviewed to determine opioid prescribing at discharge.

We hypothesise that the intervention will demonstrate a modest reduction in the prescribing of regular opioids to opioid-naive patients on discharge from surgical units.
Trial website
Trial related presentations / publications
Preliminary findings were presented at the Society of Hospital Pharmacists Medications Management annual scientific meeting (Gold Coast, November 2019) and are being presented at the Australasian Pharmaceutical Sciences Association annual meeting in Melbourne in December 2019.
Public notes

Contacts
Principal investigator
Name 83494 0
Prof Michael Dooley
Address 83494 0
Alfred Hospital
Pharmacy Department
55 Commercial Rd
Prahran Victoria 3004
Country 83494 0
Australia
Phone 83494 0
+61 3 9076 2061
Fax 83494 0
Email 83494 0
m.dooley@alfred.org.au
Contact person for public queries
Name 83495 0
Ms Ria Hopkins
Address 83495 0
Alfred Hospital
Pharmacy Department
55 Commercial Rd
Prahran Victoria 3004
Country 83495 0
Australia
Phone 83495 0
+61 3 9076 2061
Fax 83495 0
Email 83495 0
Ria.Hopkins@monash.edu
Contact person for scientific queries
Name 83496 0
Ms Ria Hopkins
Address 83496 0
Alfred Hospital
Pharmacy Department
55 Commercial Rd
Prahran Victoria 3004
Country 83496 0
Australia
Phone 83496 0
+61 3 9076 2061
Fax 83496 0
Email 83496 0
Ria.Hopkins@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD may be shared to others within the study organisation after appropriate ethics procedures are followed. No plans have been made to share data externally except in a de-identified, aggregate manner.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary