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Trial registered on ANZCTR


Registration number
ACTRN12617000744358
Ethics application status
Approved
Date submitted
22/04/2017
Date registered
22/05/2017
Date last updated
19/03/2020
Date data sharing statement initially provided
19/03/2020
Date results information initially provided
19/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study investigating the impact of different types of information in reducing patient expectations for antibiotics from general practitioners
Scientific title
The effectiveness of an educational tablet-device application in reducing patient expectations for antibiotic treatment and reducing rates of unnecessary antibiotic prescribing in primary care
Secondary ID [1] 291531 0
Nil known
Universal Trial Number (UTN)
U1111-1194-6715
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper respiratory tract infection 302623 0
Common cold 302624 0
Flu 302625 0
Condition category
Condition code
Infection 302145 302145 0 0
Other infectious diseases
Public Health 302146 302146 0 0
Health promotion/education
Mental Health 302148 302148 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered in the practice waiting room via a smart-tablet. The intervention will be delivered individually to each participant over approximately a 5 minute period. The intervention will be delivered at Balmoral Doctors (a ProCare affiliated general practice) in Auckland, New Zealand.

Participants are: patients with upper respiratory tract symptoms of common cold/flu and parents of patients aged 0-7years with upper respiratory tract symptoms who are in the general practice waiting room.
Each participant will be asked to complete a brief baseline questionnaire. Once this is done each participant will be randomised into one of three groups:
Group 1: Minimal efficacy and antimicrobial resistance [AMR] information, or
Group 2: Adverse effect information, or
Group 3: Active Control

Participants will receive the relevant information in the practice waiting room before their/their child’s appointment. The information will be delivered primarily in a written format. Given the capabilities of tablet technology, in addition to written information, content will also be delivered using static and dynamic visual imagery. Features which facilitate participant interaction with the tablet device (e.g. tapping on buttons) will also be integrated.

MINIMAL EFFICACY/AMR GROUP: Participants in this group will receive information highlighting the lack of efficacy of antibiotic treatment for colds/flu. It will also be highlighted that use of antibiotics for colds/flu can select for antibiotic resistant bacteria, and thus, reduce the efficacy of antibiotic treatment if a bacterial infection occurs in the subsequent months.

ADVERSE EFFECT GROUP: Participants in the side effect information group will receive information outlining the side effects that are commonly experienced by people/children on antibiotic medications.

ACTIVE CONTROL GROUP: Please see section below on Comparator / control treatment

After the intervention has been delivered participants will proceed to their appointment as usual. Once participants have returned to the waiting room after their/their child’s appointment, they will be asked to complete a brief post-consultation questionnaire.
Intervention code [1] 297604 0
Behaviour
Comparator / control treatment
ACTIVE CONTROL GROUP: Participants in the active control group will receive general information about keeping a healthy lifestyle (for example, exercise, nutrition etc.). The purpose of this group is to control for the time/attention given to the intervention, and consequently, to allow the effects of intervention-specific information to be examined.
Control group
Active

Outcomes
Primary outcome [1] 301582 0
Patient expectation for antibiotics will be assessed by asking participants to score the following statement ('I think it is likely my doctor will give me antibiotics for my cold/flu symptoms' ) on a 8 point Likert Scale (0= NOT LIKELY TO ALL to 7 - EXTREMELY LIKELY) before and after their appointment with the doctor.

The statement after the appointment with the doctor will be amended to reflect the fact that the patient may or may not have received a prescription from the doctor in their appointment.
These statements have been designed specifically for this study.
Timepoint [1] 301582 0
At baseline and immediately post-consultation (after appointment with general practitioner).
Secondary outcome [1] 333183 0
Prescription of antibiotic in consultation (Yes/No)
Timepoint [1] 333183 0
After their appointment with the General Practitioner participants will be asked 'Did you receive a prescription for antibiotics from your doctor today?" Participants will be able to answer "YES" or "No" to this question. This question has been designed specifically for this study

Eligibility
Key inclusion criteria
-aged over 18 years
-attending an appointment with a general practitioner at Balmoral Doctors for symptoms of
infection related to a cold/flu OR attending an appointment for a child (aged 0-7 years) with symptoms of URTI related to a cold/flu
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
­-attending an appointment with a general practitioner at Balmoral Doctors for reasons other than URTI symptoms related to a cold/flu
­-attending an appointment with a practice nurse at Balmoral Doctors
­-cannot read, write, or speak in English

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2018
Actual
5/07/2018
Date of last participant enrolment
Anticipated
Actual
30/09/2018
Date of last data collection
Anticipated
Actual
1/11/2018
Sample size
Target
255
Accrual to date
Final
325
Recruitment outside Australia
Country [1] 8766 0
New Zealand
State/province [1] 8766 0
Auckland

Funding & Sponsors
Funding source category [1] 296020 0
Hospital
Name [1] 296020 0
Auckland District Health Board (Auckland City Hospital)
Country [1] 296020 0
New Zealand
Primary sponsor type
University
Name
University of Auckland - Research Office
Address
Building 620
Level 10
49-51 Symonds St
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 295167 0
None
Name [1] 295167 0
Address [1] 295167 0
Country [1] 295167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297282 0
Health and Disability Ethics Committee
Ethics committee address [1] 297282 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 297282 0
New Zealand
Date submitted for ethics approval [1] 297282 0
01/09/2017
Approval date [1] 297282 0
28/09/2017
Ethics approval number [1] 297282 0
Ethics committee name [2] 297490 0
Auckland District Healthboard (ADHB) Research Review Committee
Ethics committee address [2] 297490 0
Level 14, Support Bldg, Auckland City Hospital.
Private Bag 92024, Auckland, New Zealand
Ethics committee country [2] 297490 0
New Zealand
Date submitted for ethics approval [2] 297490 0
01/09/2017
Approval date [2] 297490 0
Ethics approval number [2] 297490 0

Summary
Brief summary
Antimicrobial resistance (AMR) is a significant global challenge which poses a major threat to public health. The emergence and spread of antimicrobial­-resistant bacteria is accelerated by over­prescription of antibiotics; a significant contributor is the profligate use of antibiotics in primary care. In New Zealand, community dispensing accounts for significant proportion of human use of antibiotics. The level of outpatient antimicrobial consumption in NZ is comparable to that of countries such as Italy and Spain that are reported to have excessive levels of antibiotic consumption, and as a result, high levels of AMR (Thomas, et al. 2014).

In an effort to understand why excessive antibiotic prescription occurs in the GP setting, attention has been drawn to factors related to the consultation and how the patient­-physician interaction may facilitate inappropriate prescribing. In fact, Mehrotra and Linder (2016) highlight that ‘the overuse of antibiotics is largely a psychological problem’, whereby perceptions of the physician and patient play a major role in driving inappropriate prescribing.

In this study we aim to examine the impact of primary care patients’ knowledge/attitudes towards antibiotics on antibiotic prescribing. We will also aim to test the impact of different types of antibiotic ­related information (namely, i) side effects and ii) antimicrobial resistance) on patient expectations and levels of ABx prescribing. This information will be delivered to patients in the GP waiting room, prior to their consultation.

Antibiotic overuse and consequent development of AMR is an issue of significant relevance to to health of New Zealanders. Thus, we believe study findings will have important implications, particularly with regard to informing development of patient­-focused interventions to reduce use of antibiotics, both at a primary care and public health level. Results are also likely to provide valuable information to GPs on types of information which can be used to educate and modify patient expectations for antibiotics in the consultation.
Trial website
The level of inappropriate antibiotic prescribing in New Zealand general practice remains unacceptably high (Thomas et al., 2014). The major contributor is the prescribing of antibiotic treatment for common colds and the flu (upper respiratory tract infections), conditions for which antibiotics are of no benefit. Unsurprisingly, resistance to commonly used antimicrobials is rapidly increasing and is a major threat to public health.

Patient expectations for antibiotic treatment are a key driver of unnecessary prescribing. There has been little research on how to reduce patients’ expectations for antibiotics at a GP consultation, and whether reducing patient expectations can lead to significant reductions in unnecessary antibiotic prescribing.

The study is a three ­arm RCT of an intervention designed to change patient expectations for antibiotics. Before their appointment with the GP, patients with cold/flu symptoms and parents of children with cold/flu symptoms will be randomised to receive one of three different applications to view on a tablet­device:
­Group 1 Antibiotics ­ Minimal Efficacy
­Group 2 Antibiotics ­ Adverse Effects or
­Group 3 Active Control
The Minimal Efficacy and Adverse Effect interventions are designed to reduce patient expectations for antibiotics. These two interventions will be compared against the active control tablet application with regard to: a) participant expectations for an antibiotic prescription (measured before and after the intervention), b) levels of antibiotic prescribing, and c) participant satisfaction with the consultation.

Study findings will allow us to establish if an intervention delivered in the GP setting can:
a) change patient expectations for antibiotics, and
b) change levels of antibiotic prescribing. It will also provide insight into the most effective way of framing antibiotic­-related information to reduce patients’ expectations. Knowledge obtained from this study can be used to develop further educational interventions which can be readily used in the GP setting.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73566 0
A/Prof Mark Thomas
Address 73566 0
Level 6, Support Building
Auckland City Hospital
2 Park Rd,
Grafton,
Auckland 1023
Country 73566 0
New Zealand
Phone 73566 0
+64 21 412727
Fax 73566 0
Email 73566 0
[email protected]
Contact person for public queries
Name 73567 0
Anna Perera
Address 73567 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 73567 0
New Zealand
Phone 73567 0
+64 21 0390068
Fax 73567 0
Email 73567 0
[email protected]
Contact person for scientific queries
Name 73568 0
Mark Thomas
Address 73568 0
Level 6, Support Building
Auckland City Hospital
2 Park Rd,
Grafton,
Auckland 1023
Country 73568 0
New Zealand
Phone 73568 0
+64 21 412727
Fax 73568 0
Email 73568 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
All data is anonymised. Only group analyses were conducted.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7401Clinical study report https://www.dropbox.com/s/rkh6lbl7qhji9mr/Reducing%20expectations%20for%20antibiotics%20COMPLETED.pdf?dl=0 



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 372627-(Uploaded-18-03-2020-17-53-30)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.