ANZCTR - Registration

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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

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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pain management

Opioid addiction

Condition category

Condition code

Anaesthesiology

Pain management

Mental Health

Addiction

Surgery

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]

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]

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]

Discharge from hospital

Secondary outcome [1]

Daily morphine oral equivalence (MOE) on discharge from hospital, identified from discharge summary and/or discharge prescription

Timepoint [1]

Discharge from hospital

Secondary outcome [2]

Proportion of patients prescribed 'as required' opioids on discharge from hospital, identified from discharge summary and/or discharge prescription

Timepoint [2]

Discharge from hospital

Secondary outcome [3]

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]

Discharge from hospital

Secondary outcome [4]

Proportion of patients prescribed non-opioid, adjuvant analgesic medications on discharge from hospital, identified from discharge summary and/or discharge prescription

Timepoint [4]

Discharge from hospital

Secondary outcome [5]

30 day readmission rates, from hospital coding/admission data

Timepoint [5]

30 days post discharge from hospital

Secondary outcome [6]

Pain score (Numerical Rating Scale) on discharge, collected from inpatient observation charts

Timepoint [6]

Discharge from hospital

Secondary outcome [7]

Functional Activity Score (FAS) on discharge, identified from inpatient observation charts

Timepoint [7]

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

Sex

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

1/06/2018

Actual

8/07/2018

Date of last participant enrolment

Anticipated

6/05/2019

Actual

6/05/2019

Date of last data collection

Anticipated

6/06/2019

Actual

1/06/2019

Sample size

Target

4800

Accrual to date

Final

4062

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3004 - Prahran

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alfred Hospital

Address [1]

Alfred Hospital
55 Commercial Rd
Melbourne, VIC, 3004

Country [1]

Australia

Primary sponsor type

Hospital

Name

Alfred Hospital

Address

Alfred Hospital
55 Commercial Rd
Prahran
Victoria
3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Human Research Ethics Committee

Ethics committee address [1]

Alfred Hospital
55 Commercial Rd
Prahran Victoria 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/04/2018

Approval date [1]

02/05/2018

Ethics approval number [1]

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

Prof Michael Dooley

Address

Alfred Hospital
Pharmacy Department
55 Commercial Rd
Prahran Victoria 3004

Country

Australia

Phone

+61 3 9076 2061

Fax

m.dooley@alfred.org.au

Contact person for public queries

Name

Ria Hopkins

Address

Alfred Hospital
Pharmacy Department
55 Commercial Rd
Prahran Victoria 3004

Country

Australia

Phone

+61 3 9076 2061

Fax

Ria.Hopkins@monash.edu

Contact person for scientific queries

Name

Ria Hopkins

Address

Alfred Hospital
Pharmacy Department
55 Commercial Rd
Prahran Victoria 3004

Country

Australia

Phone

+61 3 9076 2061

Fax

Ria.Hopkins@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Educating junior doctors and pharmacists to reduce discharge prescribing of opioids for surgical patients: a cluster randomised controlled trial.	2020	https://dx.doi.org/10.5694/mja2.50812

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically