ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000127707

Ethics application status

Approved

Date submitted

15/12/2021

Date registered

27/01/2022

Date last updated

23/01/2023

Date data sharing statement initially provided

27/01/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Audit and feedback for reducing long-term prescribing of benzodiazepines and opioids by general practitioners

Scientific title

Evaluating audit and feedback for reducing long-term prescribing of benzodiazepines and opioids by Australian general practitioners: a factorial cluster randomised trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Examples of conditions that the medicines studies could be used for include: Insomnia (benzodiazepines)

Anxiety (benzodiazepines)

Chronic non-cancer pain (e.g., back pain, arthritis, headache, generalised pain, neuropathic pain, chronic regional pain syndrome, fibromyalgia) (opioids)

Condition category

Condition code

Mental Health

Anxiety

Musculoskeletal

Osteoarthritis

Mental Health

Other mental health disorders

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Brief name: Audit and feedback and printed educational materials

General practices in the same Australian postcode and remoteness area (RA), containing general practitioners (GPs) and other medical practitioners (OMPs) will be simultaneously randomised to no intervention control or to one of four intervention groups at baseline.

Purpose of the intervention(s): To reduce long-term prescribing of benzodiazepines and/or opioids by Australian GPs and OMPs

Procedures: Written audit and feedback with or without printed educational materials (PEM) sent to Australian GPs and OMPs

Materials: Audit and feedback letter and PEM to facilitate prescribers to identify long-term use of benzodiazepines and/or opioids in their patient cohort and support GPs and OMPs to reduce long-term prescribing.

The PEM related to benzodiazepine prescribing will provide prescribers with conversation starters to initiate a discussion with their patients about reducing long-term benzodiazepine use and a tapering algorithm to guide benzodiazepine tapering. Similar PEM related to opioid prescribing will be used - i.e. conversation starters for prescribers to initiate a discussion with their patients about reducing long term opioid use and a tapering algorithm to guide opioid tapering.

Provider: NPS MedicineWise

Mode of delivery: Mailed to the majority of participants at their nominated mailing address. A small proportion of participants (~1000-1500) have opted to receive an electronic version of the materials via their nominated email address.

Tailoring: Audit and feedback on long-term benzodiazepine and opioid prescribing individualised to the recipient. PEM not tailored to individual recipients

Fidelity: Return to sender documented

Duration of intervention: Two separate letters mailed two months apart

Interventions
GPs and OMPs within general practices allocated to one of four intervention groups (Groups 2 to 5) will receive written audit and feedback on their overall rate of prescribing of five targeted benzodiazepines and eight targeted opioids over the preceding financial year, compared with his/her peers, with or without PEM, from NPS MedicineWise. The targeted benzodiazepines are: 1) diazepam, 2) temazepam, 3) alprazolam, 4) nitrazepam, 5) oxazepam. The targeted opioids are: 1) buprenorphine, 2) fentanyl, 3) hydromorphone hydrochloride, 4) morphine sulfate pentahydrate, 5) oxycodone hydrochloride 6) oxycodone hydrochloride + naloxone) 7) tapentadol, 8) tramadol hydrochloride. Written audit and feedback with or without PEM targeting opioid prescribing will be delivered two months following the intervention targeting benzodiazepines.

Group 2 will receive standard audit and feedback illustrated in graphical format: (a) the recipient’s overall rate of prescribing of five targeted benzodiazepines that were dispensed per 1000 consultations over the preceding three financial years (1 July 2018 to 30 June 2019; 1 July 2019 to 30 June 2020; 1 July 2020 to 30 July 2021) compared with the median, 25th and 75th percentile of his/her peers located in a similar geographical region (i.e. Remoteness Area (RA)); (b) the number and percentage of patients prescribed a targeted benzodiazepine who were prescribed 4 or more prescriptions of any of the targeted benzodiazepines that were dispensed by a pharmacist over the preceding financial year (1 July 2020 to 30 July 2021) compared with the median, 25th and 75th percentile of his/her peers; c) for those patients prescribed a benzodiazepine between 1 July 2020 to 30 July 2021, the number and percentage of benzodiazepine prescriptions they received that were dispensed (1-2, 3-4, 5-6, and 7 or more).

Two months later, group 2 will receive standard audit and feedback that illustrates in graphical format: (a) the recipient’s overall rate of prescribing of eight targeted opioids that were dispensed per 1000 consultations over the preceding three financial years (1 July 2018 to 30 June 2019; 1 July 2019 to 30 June 2020; 1 July 2020 to 30 July 2021) compared with the median, 25th and 75th percentile of his/her peers located in a similar geographical region (i.e. RA); (b) the number and percentage of patients prescribed a targeted opioid who were prescribed 7 or more of any of the targeted opioids that were dispensed by a pharmacist over the preceding financial year (1 July 2020 to 30 July 2021) compared with the median, 25th and 75th percentile of his/her peers; c) for those patients prescribed a long-acting opioid by the recipient between 1 July 2020 to 30 July 2021, the number and percentage of targeted opioid prescriptions they received that were dispensed by a pharmacist (1-2, 3-4, 5-6 or 7 or more); and d) between 1 July 2020 to 30 July 2021 the number and percentage of patients prescribed and dispensed a long acting opioid 7 or more times who were also were prescribed and dispensed a benzodiazepine compared with the median, 25th and 75th percentile of his/her peers.

Group 3 will receive the same content as Group 2 but using a peer comparator tailored to the recipient’s baseline performance for long-term benzodiazepine and opioid prescribing. If the recipient’s baseline performance over the preceding financial year (1 July 2020 to 30 July 2021) for the benzodiazepine chart b (that relates to long-term benzodiazepine prescribing) is above the median percentile of his/her peers located in a similar geographical region during that time period, then the median rate will be used as the peer comparator for that medicines class and for all figures in the benzodiazepine feedback report where a peer comparator is used. If the recipient’s baseline performance over the preceding financial year for the benzodiazepine chart b is below or equal to the median percentile of his/her peers located in a similar geographical region during that period, then the 25th percentile of their peers located in a similar geographical region will be used as the peer comparator for that medicine’s class and for all figures in the benzodiazepine feedback report where a peer comparator is used. Similarly, if the recipient’s baseline performance over the preceding financial year (1 July 2020 to 30 July 2021) for the opioids chart b (that relates to long-term opioids prescribing) is above the median percentile of his/her peers located in a similar geographical region during that time period, then the median rate will be used as the peer comparator for that medicines class and for all figures in the opioids feedback report where a peer comparator is used. If the recipient’s baseline performance over the preceding financial year for the opioids chart b is below or equal to the median percentile of his/her peers located in a similar geographical region during that period, then the 25th percentile of their peers located in a similar geographical region will be used as the peer comparator for that medicines class and for all figures in the opioids feedback report where a peer comparator is used. Additional peer comparators (e.g., 75th percentile) will not be used in feedback provided to recipients allocated to group 3.

Group 4 will receive the same intervention as Group 2 but with a copy of the PEM for benzodiazepines enclosed with their benzodiazepine feedback and the opioid PEM enclosed with their opioid feedback. The PEM related to benzodiazepine prescribing will provide prescribers with conversation starters to initiate a discussion with their patients about reducing long-term benzodiazepine use and a tapering algorithm to guide benzodiazepine tapering. Similar PEM related to opioid prescribing will be used- i.e. conversation starters for prescribers to initiate a discussion with their patients about reducing long term opioid use and a tapering algorithm to guide opioid tapering.

Group 5 will receive the same intervention as Group 3 but with PEM enclosed as described for group 4.

Group labels
Group 1 – no intervention control
Group 2 - standard audit and feedback using median, 25th and 75th percentile peer comparators without PEM
Group 3 – audit and feedback using tailored peer comparator without PEM
Group 4 – standard audit and feedback using median, 25th and 75th percentile peer comparator with PEM
Group 5 - audit and feedback using tailored peer comparator with PEM

Intervention code [1]

Behaviour

Comparator / control treatment

GPs and OMPs within general practices allocated to the control group (Group 1) will not receive any written audit and feedback on their prescribing of targeted benzodiazepines and targeted opioids or printed educational materials during the trial

Control group

Active

Outcomes

Primary outcome [1]

Co-primary outcome 1 - Overall rate of targeted benzodiazepine prescriptions by each recipient that are dispensed by a pharmacist per 1000 consultations over the period 6 to 18 months following intervention delivery, assessed using PBS data. Targeted benzodiazepines are: 1) diazepam, 2) temazepam, 3) alprazolam, 4) nitrazepam and 5) oxazepam.

Timepoint [1]

Between 6 to 18 months after benzodiazepine intervention delivery (i.e., written audit and feedback on benzodiazepine prescribing with or without printed educational materials).

Primary outcome [2]

Co-primary outcome 2 - Overall rate of targeted opioid prescriptions by each recipient that are dispensed by a pharmacist per 1000 consultations over the period 6 to 18 months following intervention delivery, assessed using PBS data. Targeted opioids are: 1) buprenorphine, 2) fentanyl, 3) hydromorphone hydrochloride, 4) morphine sulfate pentahydrate, 5) oxycodone hydrochloride, 6) oxycodone hydrochloride + naloxone 7) tapentadol, 8) tramadol hydrochloride.

Timepoint [2]

Between 6 to 18 months after opioid intervention delivery (i.e., written audit and feedback on opioid prescribing with or without printed educational materials).

Secondary outcome [1]

Overall rate of targeted benzodiazepine prescriptions for each recipient per 1000 consultations that are dispensed by a pharmacist over the following periods: 0 to 6 months, >6 to 12 months and >12 to 18 months post benzodiazepine intervention delivery (where time 0 is date of intervention delivery). Assessed using PBS data.

Timepoint [1]

0 to 6 months, >6 to 12 months, and >12 to 18 months after benzodiazepine intervention delivery.

Secondary outcome [2]

Overall rate of opioid prescriptions for each recipient per 1000 consultations for the targeted opioids that are dispensed by a pharmacist over the following periods: 0 to 6 months, >6 to 12 months and >12 to 18 months post opioid intervention delivery. Assessed using PBS data.

Timepoint [2]

0 to 6 months, >6 to 12 months, and >12 to 18 months after opioid intervention delivery.

Secondary outcome [3]

Percentage of patients prescribed both 1 or more prescriptions of any targeted benzodiazepine and 1 or more prescriptions of any targeted opioid by each recipient that are dispensed by a pharmacist over the following periods: 0 to 6 months, >6 to 12 months, and >12 to 18 months post opioid intervention delivery. Assessed using PBS data.

Timepoint [3]

0 to 6 months, >6 to 12 months, and >12 to 18 months after opioid intervention delivery.

Secondary outcome [4]

Percentage of patients prescribed a targeted benzodiazepine by each recipient who received 4 or more prescriptions of any of the targeted benzodiazepines that are dispensed by a pharmacist over the following periods: 0 to 6 months, >6 to 12 months, and >12 to 18 months post benzodiazepine intervention delivery. Assessed using PBS data.

Timepoint [4]

0 to 6 months, >6 to 12 months, and >12 to 18 months after benzodiazepine intervention delivery.

Secondary outcome [5]

Percentage of patients prescribed a targeted opioid by each recipient who were prescribed 7 or more prescriptions of any of the targeted opioids that are dispensed by a pharmacist over the following periods: 0 to 6 months, >6 to 12 months, and >12 to 18 months post opioid intervention delivery. Assessed using PBS data.

Timepoint [5]

0 to 6 months, >6 to 12 months, and >12 to 18 months after opioid intervention delivery.

Secondary outcome [6]

Overall rate of targeted benzodiazepine prescriptions by each recipient that are dispensed for patients aged 65 years or older by a pharmacist per 1000 consultations over the following periods: 0 to 6 months, >6 to 12 months, and >12 to 18 months post benzodiazepine intervention delivery. Assessed using PBS data.

Timepoint [6]

0 to 6 months, >6 to 12 months, and >12 to 18 months after benzodiazepine intervention delivery.

Secondary outcome [7]

Percentage of patients aged 65 years or older prescribed a targeted benzodiazepine by each recipient who received 4 or more prescriptions of any of the targeted benzodiazepines that are dispensed by a pharmacist over the following periods: 0 to 6 months, >6 to 12 months, and >12 to 18 months post benzodiazepine intervention delivery. Assessed using PBS data.

Timepoint [7]

0 to 6 months, >6 to 12 months, and >12 to 18 months after benzodiazepine intervention delivery.

Secondary outcome [8]

Proportion of all opioid prescriptions that are prescribed and dispensed as buprenorphine fentanyl or transdermal patches over the following periods: 0 to 6 months, >6 to 12 months, and >12 to 18 months post opioid intervention delivery. Assessed using PBS data.

Timepoint [8]

0 to 6 months, >6 to 12 months, and >12 to 18 months after opioid intervention delivery.

Secondary outcome [9]

Rate of gabapentinoid prescriptions for each recipient per 1000 consultations that are dispensed by a pharmacist (calculated subject to data availability) over the following periods: 0 to 6 months, >6 to 12 months, and >12 to 18 months post opioid intervention delivery. Assessed using PBS data.

Timepoint [9]

0 to 6 months, >6 to 12 months, and >12 to 18 months after opioid intervention delivery.

Eligibility

Key inclusion criteria

General practitioners (GPs) and other medical practitioners (OMPs) practising in Australia. OMPs with a major speciality code of any of the following (as specified in MBS data dictionary, https://alswh.org.au/wp-content/uploads/2020/09/MBS_ALSWH_DataDictionary_2019.pdf) will be included:
104 - Other non-specialist
110 - Other non-specialist for nov 1996 - not elsewhere classified
181 - TRD benefits not payable
182 - TRD occupational trainee
186 - Remote OMP
188 - Medicare Plus pre 1996 OMP (restricted)
189 - Medicare Plus pre 1996 OMP (un-restricted)
196 - RRAPP
199 - MDS After Hours OMP
202 - Procedural GP - non-recognised
615 - Outer metro OMP

Only targeted benzodiazepine and targeted opioid prescriptions that lead to a medicine being dispensed by a pharmacist and for which a Pharmaceutical Benefits Scheme (PBS) claim is made are in scope.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. GPs with <160 MBS Category 1 consultations for the period 1 April 2021 to 30 June 2021.
2. GPs who have opted-out of NPS MedicineWise Practice Reviews.
3. GPs who have no primary/secondary/preferred mailing address or nominated email address.

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)

Randomisation will be conducted using a replicable randomisation algorithm in the statistical program Stata. All clusters will be randomised at once (so concealment of allocation sequence is not an issue).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation sequence will be generated using ‘ralloc’ command in Stata. The postcodes of GPs’ primary practice location will be randomised into 1 of the 5 trial arms based on: 10% no intervention controls and 1:1:1:1 ratio for 4 active intervention arms (overall group allocation ratio of 1:2.25:2.25:2.25:2.25) using stratified block randomisation based on geographical region (RA1, RA2, RA3, RA 4-5). Allocation will occur on a single occasion. Randomisation sequence with group names A, B, C, D, and E will be sent to Services Australia for matching the intervention to the trial arm. The materials will then be distributed to GPs by a third-party mail house.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Factorial design

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Multilevel mixed effects regression analysis will be used to assess impact of interventions on primary and secondary outcomes, while controlling potential confounders. The analysis will be performed at the GP level with clustering effect accounted for as a random factor (practice within the postcode). The level of significance for each primary outcome will be set at 0.025 level.

The primary analysis will be performed on modified intention to treat basis with all GPs with at least one MBS Category 1 patient consultation during the study period included in the analysis. The proportion of excluded GPs will be reported and compared across groups.

A set of sensitivity analyses will be performed to ensure the robustness of study findings.

Proposed sensitivity analyses:
- excluding those that didn’t prescribe any benzodiazepines/opioids before the intervention.
- excluding those that received an educational practice visit that may or may not target these medicines.
- excluding those that did not receive the intervention (i.e., return to senders).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/12/2023

Actual

Date of last participant enrolment

Anticipated

1/12/2023

Actual

Date of last data collection

Anticipated

30/06/2025

Actual

Sample size

Target

30000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Health

Address [1]

23 Furzer Street, Phillip ACT 2606

Country [1]

Australia

Primary sponsor type

Other

Name

NPS MedicineWise

Address

PO Box 1147
Strawberry Hills
NSW 2012

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Wiser Healthcare Collaboration

Address [1]

c/o Denise O’Connor
Monash University, Melbourne, Victoria, 3144

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University
26 Sports Walk
Clayton, VIC, 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/11/2021

Approval date [1]

16/12/2021

Ethics approval number [1]

31219

Summary

Brief summary

The primary aim of this study is to estimate the effectiveness of audit and feedback for reducing prescribing of benzodiazepines and/or opioids by Australian GPs and OMPs compared with no intervention control. A secondary aim is to evaluate the effect of two factors: tailored peer comparator (no vs. yes) and printed educational materials (no vs. yes).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Clare Weston

Address

Co-principal investigator - Denise O'Connor
NPS MedicineWise
PO Box 1147
Strawberry Hills
NSW 2012

Country

Australia

Phone

+61 02 8217 8793

Fax

[email protected]

Contact person for public queries

Name

Clare Weston

Address

NPS MedicineWise
PO Box 1147
Strawberry Hills
NSW 2012

Country

Australia

Phone

+61 02 8217 8793

Fax

[email protected]

Contact person for scientific queries

Name

Denise O’Connor

Address

Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144

Country

Australia

Phone

+61 03 9508 3428

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

IPD is not available

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14445	Study protocol	We plan to publish the protocol and statistical analysis plan before data analysis commences in open access journal or open science framework
14446	Statistical analysis plan	We plan to publish the protocol and statistical analysis plan before data analysis commences in open access journal or open science framework

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.

Trial Review

Documents added manually

Documents added automatically