Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000731291
Ethics application status
Approved
Date submitted
23/04/2018
Date registered
2/05/2018
Date last updated
14/05/2019
Date data sharing statement initially provided
14/05/2019
Date results information initially provided
14/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a multi-modal educational package for GP registrars in reviewing older patients’ medication regimens and deprescribing inappropriate medications
Scientific title
Evaluation of a multi-component educational package for GP registrars in reviewing older patients’ medication regimens and deprescribing inappropriate medications: a pragmatic evaluation employing non-equivalent control group design, nested within an ongoing cohort study.
Secondary ID [1] 294116 0
None
Universal Trial Number (UTN)
Trial acronym
Registrars’ Evaluation and Deprescribing of Inappropriate Medicines in the Elderly (RE-DIME)
Linked study record
ACTRN12614001209684 (registered 17/11/2014)..
This previous registration relates to a project employing similar methodology with a non randomised evaluation of a teaching intervention nested within the same ongoing cohort study (ReCEnT).

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 306710 0
Inappropriate medicines in the elderly 307566 0
Condition category
Condition code
Public Health 305810 305810 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 training organization. The outcomes in this training package will be compared using data from an ongoing cohort study, The Registrar Clinical Encounters in Training (ReCEnT), (an ongoing cohort study of GP trainees’ in-practice clinical and educational experiences and behaviours), with outcomes from other training organizations which have not incorporated the educational package.
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.
The educational intervention consists of four components. The first two i.e. access to an online introduction module, and a 60 minute face-to-face session, will be delivered to GP registrars (graduate trainees in the Australian specialist GP vocational training program). The third is a webinar for clinical supervisors of these registrars based on the face-to-face presentation. The fourth is an optional joint GP registrar-supervisor education activity, which comprises a case-based discussion of evidence-based deprescribing for each trainee-supervisor dyad in their regular weekly one-on-one teaching meetings. Supervisors will also have pre-webinar access to the online introductory model.
Supervisors are experienced GPs who oversee the within-practice education of registrars..
1.. Online introduction module: The bulk of the background material will be included in the online module to allow a deeper exploration of practical approaches to deprescribing in the face-to-face session. This introduction module will include material on polypharmacy, inappropriate prescribing in older patients, evidence for deprescribing, an introduction to tools for assessing potentially inappropriate prescribing such as the Beer’s criteria and the Drug Burden Index and the role of general practitioners in the implementation of deprescribing. The module will also include a discussion of why polypharmacy is a priority for physicians. This module will take approximately 30-40 minutes to complete. It will contain links to supporting materials. The online module will be made available to registrars to work through individually at a time prior to the face-to-face session. They will be given a time frame of 2-3 weeks in which to complete the module.
The module will also be made available to supervisors prior to their webinar..
2. Face-to-face session: The face-to-face session will consist of a 60-minute educational presentation in a group setting with approximately 450 registrars scheduled as part of the standard training program for GP registrars delivered at GP Synergy, their Regional Training Organisation (RTO). The face-to-face session will be led by a geriatrician. A GP experienced in supervising GP registrars will provide further clinical relevance and expertise.
In the face-to-face session, data on GP trainees' deprescribing, 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 2016 and 2017). During the session, GP registrars, by means of clinical cases, will work through the main principles of rational deprescribing. Time will be devoted to the practicalities of how to go about deprescribing within a general practice setting, including how to determine if a patient has polypharmacy; determining the risks vs benefits of a continuing or of deprescribing a particular medicine; identifying opportunities for deprescribing; and how to employ a model of deprescribing. Examples tailored to the general practice setting will be provided. Aspects of patient opinion towards deprescribing will be covered as well as barriers inherent within the general practice setting and the registrar’s position within a host practice e.g dealing with older patients whose management the registrar may not usually engage with, and with whom registrars are less likely to have developed a deeper relationship. Collaborative models of registrars and supervisors working together to implement appropriate deprescribing will be promoted.
Post-session supporting resources will be available as links in the Deprescribing online module to reinforce the workshop and provide practical resources including guides to deprescribing individual drug classes (e.g. benzodiazepines and anticholinesterases).
The workshop session content will be constructed by the research team of GPs, GP vocational training educators, academic GPs, and a geriatrician researcher. The process will be informed by the current literature in the area and our recent work in documenting GP registrars' deprescribing including the prevalence and associations of deprescribing in older patients.
3. Supervisor Webinar: The webinar content will be a more succinct version of the face-to-face workshop session provided to registrars, because supervisors will be more aware of deprescribing and the mechanisms available for practical deprescribing. Supervisors find difficulty in deprescribing in cases where specialists originally established the prescription. Because this is an analogous dyad to that of the registrar-supervisor, approaches to managing the GP-specialist relationship will be covered.
The webinar will emphasize potential models of supervisor-registrar collaboration in deprescribing for individual patients.
4. Joint registrar/ supervisor activity: Each registrar-supervisor dyad will be encouraged to include a case-based discussion of evidence-based
deprescribing 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. Other options, such as ‘random case analysis’ or audit of older patients’ clinical notes will be suggested. 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 session and webinar will be delivered by Professor Sarah Hilmer (Geriatrician with particular expertise in adverse effects of medicines in older patients and in rational deprescribing), supported by an experienced GP supervisor (to be advised).
Delivery Mode: Face-to-face delivery +
online learning module + online webinar + provision of supporting resources, papers, links to appropriate online material.
Number of times: The registrar educational session face-to- face will be delivered as one x one hour session. The supervisor educational intervention via webinar will be delivered as one x one hour session.
The online module and supporting resources may be accessed as often as the participant requires.
Location: The registrar face-to-face session will be delivered during a routinely-scheduled educational workshop in Sydney.
The on-line module will be accessed by registrars and supervisors at sites convenient to them.
The on-line webinar will be accessed by supervisors at sites convenient to them.
The optional registrar-supervisor teaching session will be held in the practice premises 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
Website analytics ( On-line introduction module) How many registrars and supervisors have accessed the module and how many registrars and supervisors have completed the module will be recorded.
Intervention code [1] 300397 0
Behaviour
Comparator / control treatment
The ‘control group’ of registrars training with two other Regional Training Organisations will receive “usual education” during the study period. Usual education comprises teaching/education as scheduled by the control Regional Training Organisations which may include some education in deprescribing medicines in older patients.
’Usual education’ will not include the online introduction training component nor provision of materials for use in registrar-supervisor practice-located teaching sessions.
Control group
Active

Outcomes
Primary outcome [1] 304875 0
Change in the number of medicines deprescribed by registrars per 100 consultations with patients aged 65 years or older. The number of medicines deprescribed per 100 consultations with patients aged 65 years and older will be calculated using deprescribing data recorded in-consultation by each registrar for 60 consecutive patient consultations once each six months as part of the ReCEnT cohort study.
In ReCEnT, registrars complete a case report form for every one of a total of 60 consecutive clinical encounters (consultations) during each term of their GP registrar training. In the case report form medications ceased (ie deprescribed) in that consultation are recorded.
Timepoint [1] 304875 0
Pre-intervention ReCEnT data will be collected six-monthly (that is, in 2018.1, 2017.2, 2017.1, 2016.2 training semesters). Each registrar collects data (on 60 consecutive 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.
Primary outcome [2] 304876 0
Change in the number of medicines from a) the Beer’s Criteria list of Potentially Inappropriate Medications and/or b) the Drug Burden Index and/or iii) the medicine groups most highly rated as suitable for deprescribing by a Canadian expert clinician Delphi process deprescribed by registrars per 100 consultations with patients aged 65 years and older. The number of medicines deprescribed per 100 consultations with patients aged 65 years and older will be calculated using deprescribing data recorded in-consultation by each registrar each six months as part of the ReCEnT cohort study.
In ReCEnT, registrars complete a case report form for every one of a total of 60 consecutive clinical encounters (consultations) during each term of their GP registrar training. In the case report form medications ceased (ie deprescribed) in that consultation are recorded.
Timepoint [2] 304876 0
Pre-intervention ReCEnT data will be collected six-monthly (that is, in 2018.1, 2017.2, 2017.1, 2016.2 training semesters). Each registrar collects data (on 60 consecutive 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] 343444 0
Change in the number of medicines deprescribed per 100 consultations with patients aged 65 years or older, with analysis restricted to medicines which have been taken by patients for three months or greater.
In ReCEnT, registrars complete a case report form for every one of a total of 60 consecutive clinical encounters (consultations) during each term of their GP registrar training. In the case report form medications ceased (ie deprescribed) in that consultation are recorded, and it is also recorded whether the medication had been taken by the patient for more than three months or less than three months.
Timepoint [1] 343444 0
Pre-intervention ReCEnT data will be collected six-monthly (that is, in 2018.1, 2017.2, 2017.1, 2016.2 training semesters). Each registrar collects data (on 60 consecutive 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 [2] 343445 0
Change in the number of medicines deprescribed by registrars per 100 consultations with patients aged 65 years or older, or for which medicine dose was reduced with a view to later cessation.
In ReCEnT, registrars complete a case report form for every one of a total of 60 consecutive clinical encounters (consultations) during each term of their GP registrar training. In the case report form medications for which dose was reduced with a view to ceasing is recorded.
Timepoint [2] 343445 0
Pre-intervention ReCEnT data will be collected at the six-monthly ReCEnT data collection for the 2018.1 training semester. Each registrar collects data (on 60 consecutive 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.
Post-intervention data will be collected in the 2018.2 training semester i.e four months post-intervention.
Secondary outcome [3] 343446 0
Change in anticipated deprescribing 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 ‘appropriate deprescribing chosen’ or ‘appropriate deprescribing not chosen’. This outcome will apply only to intervention group registrars. Control group registrars will not participate in the questionnaire study.
The questionnaire was specifically designed for the study by a panel of GP clinical educators (CG, JF, PM), a geriatrician with expertise in clinical pharmacology, prescribing and deprescribing in older people (SH), and a GP academic registrar (RT).
Timepoint [3] 343446 0
One month pre-intervention and two months post-intervention.
Secondary outcome [4] 343447 0
Registrars’ and supervisors’ experiences of undertaking the intervention as measured by semi-structured qualitative interview. This outcome will apply only to intervention group registrars. Control group registrars or supervisors will not participate in the questionnaire study.
Timepoint [4] 343447 0
The qualitative interviews will be conducted over a two month period (allowing for iterative data collection and analysis), commencing two months post-intervention.

Eligibility
Key inclusion criteria
For the analysis using ReCEnT study data:
Intervention group: Registrars in Terms 1 and 2 of their vocational training program at one RTO (GP Synergy)
Control group: Registrars in Terms 1 and 2 of their vocational training program at two RTOs (General Practice Training 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 (who have attended the webinar intervention) of GP Synergy registrars
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For the analysis 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 webinar

Registrars or supervisors who have not attended the workshop or webinar

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 non-equivalent control group design, nested within an ongoing cohort study.
Component 2: A simple pre- and post-intervention design.
Pre- and Post-questionnaire: Pre- and post-face-to-face session questionnaires will elicit participant registrars’ medication management responses to a number of general practice vignettes (clinical scenarios) involving polypharmacy in older patients. These clinical vignettes will be designed to reflect situations where deprescribing of medication is either recommended or not warranted, consistent with current research.
Component 3: Qualitative evaluation
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’ practices have changed and barriers to / facilitators of such change.
The qualitative study will employ semi-structured interviews vis telephone or Skype.

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Component 1: Analysis involving ReCEnT data:
Only data on patients 65 years or older will be included in the analysis.
Analysis will employ ReCEnT data 2016-2018.
The number of medicines deprescribed per 100 consultations with patients aged 65 years or older will be the primary outcome measure.
Analysis 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 deprescribing education 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 deprescribing. ’Intention to treat’ analyses will be conducted.
Sample size: Power has been estimated based on detectable differences in deprescribing rates between intervention and control groups, post-intervention.
We have estimated the detectable effect size assuming a total sample size 6,590 encounters with patients aged >65 years for 624 registrars post-intervention. The intervention to control allocation ratio is approximately 2.7 : 1. Assuming a deprescribing rate of 2.1% in control consultations, we will have 80% power to detect a deprescribing rate of 3.4% in intervention consultations, post-intervention, at a two-sided significance level of 0.05. This corresponds with a 62% increase in the deprescribing rate (Relative risk = 1.62). Allowing for potential clustering of deprescribing rates within registrars, assuming possible ICCs of either 0.01 or 0.02, we will be able to detect post-intervention deprescribing rate increases of 65% (RR=1.65) and 68% (RR=1.68). This assumes each registrar has 10 – 11 relevant encounters, corresponding to Design Effects of 1.095 and 1.19, respectively.
Component 2: For the questionnaire-based evaluation:
McNemars test will be used to assess changes in responses to clinical vignettes pre- and post-intervention.
Component 3: For the qualitative evaluation:
Thematic analysis will be employed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2018
Actual
4/05/2018
Date of last participant enrolment
Anticipated
15/10/2018
Actual
15/10/2018
Date of last data collection
Anticipated
25/10/2018
Actual
15/02/2019
Sample size
Target
624
Accrual to date
Final
624
Recruitment in Australia
Recruitment state(s)
ACT,NSW,TAS,VIC

Funding & Sponsors
Funding source category [1] 298753 0
Charities/Societies/Foundations
Name [1] 298753 0
Royal Australian College of General Practitioners Educational Research Grant
Country [1] 298753 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] 297929 0
Individual
Name [1] 297929 0
Professor Mieke van Driel
Address [1] 297929 0
Primary Care Clinical Unit
Faculty of Medicine
Level 8, Health Sciences Building16/901, Royal Brisbane & Women's Hospital
Herston Qld 4029, Australia
Country [1] 297929 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299689 0
Human Research Ethics Committee University of Newcastle
Ethics committee address [1] 299689 0
The University of Newcastle Research Integrity Unit
Research Services
HA148 Hunter Building
University Drive
CALLAGHAN NSW 2308.
Ethics committee country [1] 299689 0
Australia
Date submitted for ethics approval [1] 299689 0
14/02/2018
Approval date [1] 299689 0
18/04/2018
Ethics approval number [1] 299689 0
H-2009-0323

Summary
Brief summary
The primary purpose of the RE-DIME study is to assess the impact of a multi-component education package on GP registrars’ medicines deprescribing. We hypothesize that an appropriately targeted educational package will improve adherence to evidence-based guidelines regarding deprescribing of inappropriate medicines in patients over 65 years by GP registrars participating in a vocational training program.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
The RE-DIME study is embedded within the ReCEnT study which commenced in February 2009. Ethics approval was obtained for the ReCEnT study in 2009 (ref no: H-2009-0323). Additional ethics approval for the RE-DIME study is under the umbrella of the ReCEnT study and was granted 18th April 2018.
Attachments [1] 2623 2623 0 0
/AnzctrAttachments/374562-BC04a Expedited Appr Variation.pdf (Ethics approval)
Attachments [2] 2624 2624 0 0
/AnzctrAttachments/374562-FUSIONWorkshop_InvitationLetter_POSTV2.DOC (Participant information/consent)
Attachments [3] 2625 2625 0 0
/AnzctrAttachments/374562-FUSION Workshop_InformationStatement_POSTV2.doc (Participant information/consent)
Attachments [4] 2626 2626 0 0
/AnzctrAttachments/374562-ReCEnT_Registrar Information_Statement_GP Synergy_2018.docx (Participant information/consent)
Attachments [5] 2627 2627 0 0
/AnzctrAttachments/374562-ReCEnT_Registrar_Consent_Form_GP Synergy_2018.1.docx (Participant information/consent)

Contacts
Principal investigator
Name 81306 0
Prof Parker Magin
Address 81306 0
Director GP Synergy NSW and ACT
Research and Evaluation Unit;
Level 1, 20 McIntosh Dr, Mayfield West, NSW 2304

Country 81306 0
Australia
Phone 81306 0
+61 408 953 872
Fax 81306 0
Email 81306 0
[email protected]
Contact person for public queries
Name 81307 0
Prof Parker Magin
Address 81307 0
Director GP Synergy NSW and ACT
Research and Evaluation Unit;
Level 1, 20 McIntosh Dr, Mayfield West, NSW 2304

Country 81307 0
Australia
Phone 81307 0
+61 408 953 872
Fax 81307 0
Email 81307 0
[email protected]
Contact person for scientific queries
Name 81308 0
Prof Parker Magin
Address 81308 0
Director GP Synergy NSW and ACT
Research and Evaluation Unit;
Level 1, 20 McIntosh Dr, Mayfield West, NSW 2304

Country 81308 0
Australia
Phone 81308 0
+61 408 953 872
Fax 81308 0
Email 81308 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
This trial is nested in an ongoing cohort study. Data will be used of participants who participated prior to the consent process for the cohort study including permission to provide data to other parties.


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.