Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000824268
Ethics application status
Approved
Date submitted
9/05/2018
Date registered
15/05/2018
Date last updated
15/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a multi-modal educational package for GP registrars in improving guideline compliance for prescription of benzodiazepines and related drugs in general practice.
Scientific title
Evaluation of a multi-component educational package for GP registrars in improving guideline compliance for prescription of benzodiazepines and related drugs in general practice: a pragmatic evaluation employing a non-equivalent control group design, nested within an ongoing cohort study.
Secondary ID [1] 294837 0
None
Universal Trial Number (UTN)
Trial acronym
BENzodiazepines: Enhancing compliance For reduced-prescribing In Training (BENEFIT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inappropriate prescribing 307783 0
Condition category
Condition code
Public Health 306826 306826 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The educational package being evaluated is one that is being developed to be incorporated as part of the usual ongoing educational program of a single, large Australian general practice vocational Regional Training Organisation (RTO).
The outcomes in this training program will be compared using data from the ongoing cohort study, Registrar Clinical Encounters in Training (ReCEnT), (an ongoing cohort study of GP trainee’s in practice clinical and educational experiences and behaviours) with outcomes from two other RTOs which have not incorporated the educational package in their training programs.
Thus, the study can be viewed as observational with evaluation of the educational package being nested within an ongoing cohort study. For the purposes of the ANZCTR format, however, we have classified the study type as Interventional. Similarly, in this document the educational package will be referred to as the ‘intervention’ rather than the exposure.
In this document ‘benzodiazepines’ will refer to benzodiazepines and related drugs such as Z-drugs (zopiclone and zolpidem).
The multicomponent educational intervention will be delivered during 2018 to all registrars (trainees) training with GP Synergy (the RTO responsible for delivering education and training for all GP registrars in New South Wales and the Australian Capital Territory) and consists of four educational components. These components are:
1) Pre- and post-workshop educational resources: A small number of relevant journal articles will be provided by email and specified as pre-reading (two weeks prior) for the face-to-face educational session. Electronic links to post-workshop resources will be available immediately after the workshop.
Pre-workshop readings will cover anxiety and sleep disorders and provide background and evidence highlighting the harms of benzodiazepine use. Pre-reading will address the literature / guidelines which advocate benzodiazepines as a third-line, short-term treatment option for anxiety and insomnia.
2) Face-to-face session: The face-to-face session will consist of a 40-minute educational presentation in a group setting with approximately 450 registrars scheduled to attend as part of the standard training program for GP registrars delivered by GP Synergy, their RTO. The face-to-face session will be led by an experienced GP/ addiction physician and an experienced clinical psychologist.
In the face-to-face session, data on GP registrars' benzodiazepine prescribing collected in the ReCEnT project will be used to contextualize and reinforce the practical relevance and importance of the educational message (the ReCEnT data will be that of registrars who have participated in ReCEnT during 2010 to 2017).
The presentation will acknowledge the factors leading to benzodiazepine use, and the focus of the presentation will be the practicalities of how to manage anxiety and insomnia within a general practice setting utilizing psychological strategies. The psychological strategies will aid registrars in avoiding initiation of benzodiazepines and may potentially augment benzodiazepine withdrawal management approaches. The session will incorporate clinical scenarios of anxiety or insomnia in which non-pharmacological, psychological approaches rather than benzodiazepine prescription will be appropriate. The clinical psychologist will lead activities on rehearsing Cognitive Behaviour Therapy (CBT), distracting, mindfulness, relaxation/self-calming techniques. These non-pharmacological techniques will be recommended to registrars as practical strategies to employ in their management of patients with anxiety or insomnia.
The workshop session has been constructed by the research team of GPs, GP vocational training educators, academic GP’s, an experienced specialist addiction physician, and an experienced clinical psychologist. The process will be informed by the current literature in the area, and the findings of the ReCEnT project in documenting GP registrar’s benzodiazepine prescribing and management of anxiety and insomnia.
3) Supervisor Webinar: A one-hour webinar will be held for supervisors during July 2018, after the registrar face-to-face session. The webinar content will be a more succinct version of the face-to-face registrar session, because supervisors will be more aware of benzodiazepine use and non-pharmacological management of anxiety and insomnia.
The webinar will, additionally, emphasize potential models of supervisor-registrar collaboration in minimizing benzodiazepine prescription and in incorporating non-pharmacological methods of managing anxiety and insomnia in the general practice setting.
The webinar content will thus promote supervisor facilitation of guideline-consistent practice in benzodiazepine prescribing and insomnia/anxiety management by their registrars. It is also intended that supervisors will reflect on and modify their own practice in this area (as supervisors’ clinical behavior influences registrar behaviour).
4) Joint registrar/supervisor activity: Each registrar-supervisor dyad will be encouraged to include case-based discussions of evidence-based anxiety and/or insomnia management in their regular weekly one-on-one teaching meetings. The supervisor will be offered a set of three or four structured cases to include in the meeting (e.g. new patient presenting with insomnia/anxiety, or a patient with an existing prescription for benzodiazepines). The joint registrar/supervisor activity will be optional as the content of registrar-supervisor weekly meetings is at the discretion of the supervisors and registrars rather than the RTO.

Who: The face-to-face educational workshop and online supervisor session will be delivered by Dr Simon Holliday (GP and specialist addiction physician with previous experience as chair of the Pain Management Network of the Royal Australia College of General Practitioners (RACGP)). The face-to-face educational workshop and online supervisor session will be co-delivered by a clinical psychologist, Professor Michael Nicholas.
Delivery Mode: Face-to-face workshop delivered within a large group setting, online supervisor webinar, and provision of supporting resources, papers, links to appropriate online material.
Number of Times: The registrar face-to-face educational workshop will be delivered as one forty-minute session. The online supervisor session via webinar will be delivered as one one-hour session. The emailed supporting resources may be accessed as often as the participant requires.
Location: The registrar face-to-face session will be delivered as one forty minute session during a routinely-scheduled educational workshop in Sydney. Supporting resources may be accessed as often as the participant requires.
The online supervisor educational intervention will be delivered as a single one hour session, and will be accessed by supervisors at sites convenient to them.
The optional registrar-supervisor teaching session will be held in the general practice of the particular registrar/ supervisor dyad.
Strategies used to monitor fidelity/adherence to the intervention: Attendance rolls (face-to-face registrar session and supervisor webinar).
Intervention code [1] 301147 0
Behaviour
Comparator / control treatment
The ‘comparison group’ of registrars from two other Regional Training Organisations (General Practice Training Tasmania and Eastern Victoria General Practice Training) will receive “usual education” during the study period. Usual educational comprises teaching/education as scheduled by the comparator Regional Training Organisations which will include some education in benzodiazepine use.
‘Usual education’ will not include a dedicated session on non-pharmacological management of anxiety and insomnia nor provision of the materials for use in registrar-supervisor practice-located teaching sessions.
Control group
Active

Outcomes
Primary outcome [1] 305821 0
The primary outcome measure will be ‘frequency of benzodiazepine prescription’ as measured by ReCEnT data. In ReCEnT, registrars complete a case report form for every one of a total of sixty consecutive clinical encounters (consultations) during each term of their GP registrar training. In the case report form, benzodiazepine prescriptions are recorded.
Timepoint [1] 305821 0
Pre-intervention ReCEnT data will have been collected six-monthly (that is, 2018.1, 2017.2, 2017.1, 2016.2, 2016.1, 2015.1, 2015.2, 2014.2, 2014.1, 2013.2, 2013.1, 2012.2, 2012.1, 2011.2, 2011.1, 2010.2, 2010.1 training semesters). Each registrar collects data (on 60 consultative consultations) once during each of their 6-month duration terms. Due to logistical factors, this six-monthly data collection is not synchronous across all registrars. It is aimed to be at the mid-point of their 6-month term. This will be two months before the intervention (for the 2018.1 data collection – it will be 8 months prior to the intervention for the 2017.2 data collection, etc.).
Post intervention data will be collected in the 2018.2 training semester (i.e. four months post-intervention).
Secondary outcome [1] 346672 0
‘Frequency of benzodiazepine initiation’ as measured by ReCEnT data. In ReCEnT, registrars complete a case report form for every one of a total of sixty consecutive clinical encounters (consultations) during each term of their GP registrar training. In the case report form, benzodiazepine prescriptions are recorded.
Timepoint [1] 346672 0
Pre-intervention ReCEnT data will be collected six-monthly (that is, 2018.1, 2017.2, 2017.1, 2016.2, 2016.1, 2015.1, 2015.2, 2014.2, 2014.1, 2013.2, 2013.1, 2012.2, 2012.1, 2011.2, 2011.1, 2010.2, 2010.1 training semesters). Each registrar collects data (on 60 consultative consultations) once during each of their 6-month duration terms. Due to logistical factors, this six-monthly data collection is not synchronous across all registrars. It is aimed to be at the mid-point of their 6-month term. This will be two months before the intervention (for the 2018.1 data collection – it will be 8 months prior to the intervention for the 2017.2 data collection, etc.).
Secondary outcome [2] 346673 0
Change in anticipated prescribing behaviour as measured by responses to clinical vignettes in a questionnaire. Responses will be via multiple choice options of actions in response to each clinical vignette and will be classified as ‘inappropriate benzodiazepine deprescribing chosen’ or ‘inappropriate benzodiazepine deprescribing not chosen’. This outcome will apply only to intervention group registrars. Comparator group registrars will not participate in the questionnaire study.
The questionnaire was specifically designed for the study by a panel of GP clinical educators (SH, MvD, PM), and a clinical psychologist (MN).
Timepoint [2] 346673 0
One-month pre-intervention and two months post-intervention.
Secondary outcome [3] 346674 0
Registrars’ and supervisors’ experiences of undertaking the intervention as measured by semi-structured qualitative interviews. This outcome will apply only to intervention group registrars and their supervisors. Comparator group registrars will not participate in the questionnaire study.
Timepoint [3] 346674 0
The qualitative interviews will be conducted over a two month period (allowing for iterative data collection and analysis), commencing two months post-intervention (therefore, date of last data collection will take place 4 months post intervention).

Eligibility
Key inclusion criteria
For the analyses using ReCEnT study data:
Intervention group: Registrars in Terms 1 and 2 of their vocational training program at one RTO (GP Synergy)
Comparator group: Registrars in Terms 1 and 2 of their vocational training program at two RTOs (General Practice Tasmania (GPTT) and Eastern Victoria GP Training (EVGP)).
For the questionnaire-based study:
Registrars in Terms 1 and 2 of their vocational training program at one RTO (GP Synergy) at the commencement of the study.

For the qualitative study:
Registrars in Terms 1 and 2 of their vocational training program at one RTO (GP Synergy) who have attended the workshop intervention and supervisors of these GP Synergy registrars who have attended the webinar intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For the analyses using ReCEnT study data:
Registrars who do not provide consent for the data they collect as part of the ReCEnT project to be used for research purposes.

For the questionnaire-based study:
No exclusions

For the Qualitative study:
Registrars or supervisors who have not attended the workshop or online supervisor session.

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



Intervention assignment
Parallel
Other design features
Component 1: A pragmatic evaluation employing a non-equivalent control group design, nested within an ongoing cohort study.

Component 2: A simple pre- and post-intervention design. Pre- and post- face-to-face workshop session questionnaires will elicit participant registrars’ management of anxiety and insomnia responses to a number of general practice vignettes (clinical scenarios) involving potential benzodiazepine prescription in patients. These clinical vignettes will be designed to reflect situations where benzodiazepine prescription is not recommended or not warranted, consistent with current evidence.

Component 3: A qualitative evaluation of the educational package will be conducted to elicit
i) GP registrars’ and supervisors’ opinions on how the intervention worked well and how it could improve;
ii) How GP registrars’ clinical management practices have changed and barriers to / facilitators of such change. The qualitative study will employ semi-structured interviews via telephone or Skype.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Component 1: Analyses involving ReCEnT data.
Analyses will use ReCEnT data 2010-2018.
Analyses will employ univariate and multivariable logistic regression within the generalized estimating equations (GEE) framework to account for repeated measures within registrars. The interaction term for ‘treatment group’ (whether the registrar was enrolled with the RTO in which the benzodiazepine educational package was delivered) and pre/post intervention timing of data collection will be used to test the significance of a treatment effect of the intervention on benzodiazepine prescribing. ‘Intention to treat’ analyses will be conducted.
Sample size: There will be approximately 450 registrars from the intervention RTO eligible to attend the face-to-face educational session and approximately 624 registrars, in all (intervention and comparator RTOs), with post-intervention data. Power-sample size calculations are based on this.
Assuming a similar pre-intervention prescribing rate in comparator and intervention consultations, and that the comparator group shows no change in prescribing rates from pre- to post-intervention, power has been estimated based on detectable differences in prescribing rates between intervention and comparator groups, post-intervention.
We have estimated the detectable effect size assuming a total sample size of 29,952 encounters with patients aged >16 years for 624 registrars, post-intervention. The intervention to comparator allocation ratio is approximately 2.7 : 1 . Assuming a benzodiazepine prescribing rate of 2.2 % in comparator consultations (from previous ReCEnT data), we will have 80% power to detect a prescribing rate of 1.7 % in intervention consultations, post-intervention, at a two-sided significance level of 0.05. This corresponds with a 23% decrease in the prescribing rate (Relative risk = 0.77). Allowing for potential clustering of prescribing rates within registrars, assuming possible Intracluster Correlation Coefficients of either 0.01 or 0.02, we will be able to detect post-intervention prescribing rate decreases of 27% (RR=0.73) and 31% (RR=0.69), respectively. This assumes each registrar has 48 encounters, corresponding to Design Effects of 1.47 and 1.94, respectively.

Component 2: For the questionnaire-based evaluation.
McNemar’s test will be used to assess changes in responses to clinical vignettes pre- and post-intervention.

Component 3: For the qualitative evaluation.
Thematic analysis of transcribed interviews will be employed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/05/2018
Date of last participant enrolment
Anticipated
15/10/2018
Actual
Date of last data collection
Anticipated
25/10/2018
Actual
Sample size
Target
624
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,TAS,VIC

Funding & Sponsors
Funding source category [1] 299433 0
Charities/Societies/Foundations
Name [1] 299433 0
Royal Australian College of General Practitioners Educational Research Grant
Country [1] 299433 0
Australia
Primary sponsor type
Individual
Name
Professor Parker Magin
Address
GP Synergy NSW and ACT Research and Evaluation Unit PO Box 3398 Liverpool Westfield NSW 2170
Country
Australia
Secondary sponsor category [1] 298722 0
Individual
Name [1] 298722 0
Dr Simon Holliday
Address [1] 298722 0
Albert St Medical Centre
PO Box 834
78 Albert St
Taree NSW 2430
Country [1] 298722 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300332 0
University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 300332 0
The University of Newcastle Research Integrity Unit Research Services
HA148 Hunter Building
University Drive
CALLAGHAN NSW 2308
Ethics committee country [1] 300332 0
Australia
Date submitted for ethics approval [1] 300332 0
14/02/2018
Approval date [1] 300332 0
18/04/2018
Ethics approval number [1] 300332 0
H-2009-0323

Summary
Brief summary
The primary purpose of this study is to assess the impact of a multicomponent education package (concerning non-pharmacological management of anxiety and insomnia) on GP registrars’ benzodiazepine prescribing. We hypothesize that an appropriately targeted educational package will improve adherence to evidence-based guidelines regarding prescription of benzodiazepine and non-pharmacological management of anxiety and insomnia for patients by GP registrars participating in a vocational training program.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
This study is nested within the ReCEnT study, which has been going since 2009 when the initial ethics approval was obtained (ref no: H-2009-0323). Additional ethics approval was sought from the Human Research Ethics Committee (HREC), University of Newcastle for this study under the umbrella of the ReCEnT study. This additional request was granted 18th April 2018.
Attachments [1] 2680 2680 0 0
/AnzctrAttachments/375066-BC04a Expedited Appr Variation.pdf (Ethics approval)
Attachments [2] 2681 2681 0 0
/AnzctrAttachments/375066-FUSIONWorkshop_InvitationLetter_POSTV2.DOC (Participant information/consent)
Attachments [3] 2682 2682 0 0
/AnzctrAttachments/375066-FUSION Workshop_InformationStatement_POSTV2.doc (Participant information/consent)
Attachments [4] 2683 2683 0 0
/AnzctrAttachments/375066-ReCEnT_Registrar Information_Statement_GP Synergy_2018.docx (Participant information/consent)
Attachments [5] 2684 2684 0 0
/AnzctrAttachments/375066-ReCEnT_Registrar_Consent_Form_GP Synergy_2018.1.docx (Participant information/consent)

Contacts
Principal investigator
Name 83322 0
Prof Parker Magin
Address 83322 0
Director GP Synergy NSW and ACT
Research and Evaluation Unit
Level 1, 20 Mclntosh Dr, Mayfield West, NSW 2304
Country 83322 0
Australia
Phone 83322 0
+61 408 953 872
Fax 83322 0
Email 83322 0
[email protected]
Contact person for public queries
Name 83323 0
Prof Parker Magin
Address 83323 0
Director GP Synergy NSW and ACT
Research and Evaluation Unit
Level 1, 20 Mclntosh Dr, Mayfield West, NSW 2304
Country 83323 0
Australia
Phone 83323 0
+61 408 953 872
Fax 83323 0
Email 83323 0
[email protected]
Contact person for scientific queries
Name 83324 0
Prof Parker Magin
Address 83324 0
Director GP Synergy NSW and ACT
Research and Evaluation Unit
Level 1, 20 Mclntosh Dr, Mayfield West, NSW 2304
Country 83324 0
Australia
Phone 83324 0
+61 408 953 872
Fax 83324 0
Email 83324 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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