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Trial registered on ANZCTR


Registration number
ACTRN12615000843550
Ethics application status
Approved
Date submitted
31/07/2015
Date registered
13/08/2015
Date last updated
6/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of decision aids for parents about the benefits and harms of antibiotic use for coughs and colds in children.
Scientific title
Pilot randomised controlled trial of decision aids for parents about the benefit and harm of antibiotics for common acute respiratory infections in children to aid informed decision making.
Secondary ID [1] 287154 0
Nil
Universal Trial Number (UTN)
U1111-1172-5927
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory infections 295715 0
Condition category
Condition code
Respiratory 295993 295993 0 0
Other respiratory disorders / diseases
Infection 296094 296094 0 0
Other infectious diseases
Public Health 296095 296095 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Decision aids developed for parents to communicate the benefit and harm of antibiotics for treatment of acute otitis media, sore throat and acute bronchitis (cough).

The single A4 double-sided decision aids (one for each condition) was developed in accord with International Patients Decision Aid Standards (IPDAS) international quality criteria; and informed by:
a) a nationwide survey exploring parents’ expectations of antibiotic benefits and harms for childhood ARIs (needs assessment);
b) relevant Cochrane systematic review evidence for quantification of antibiotic benefit and risk (clinical evidence);
c) Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group assessment (quality of the evidence), and;
d) Risk communication research (for numerical, graphical and narrative presentation of data).

The instruments are designed to be read in approximately 5 minutes, and no further information or advice is required to aid comprehension. The decision aids have initially been developed in English only, and the Flesch-Kincaid readability score used to ensure content is suitable for readers at around the eighth grade level.
Intervention code [1] 292424 0
Other interventions
Comparator / control treatment
Written (narrative) information summaries for acute otitis media, sore throat and acute bronchitis (cough) currently available to the Australian general public from an independent, not-for-profit, Australian consumer information source (NPS MedicineWise).
Control group
Active

Outcomes
Primary outcome [1] 295664 0
Primary outcome 1: Informed choice. Assessed using the multi-dimensional model of informed choice which consists of three constructs: (a) knowledge (conceptual and numerical) about benefits and harms of antibiotics used for acute otitis media, sore throat and acute cough in children; (b) attitudes towards antibiotic use for acute otitis media, sore throat and acute cough in children, and; (c) intention to use an antibiotic for each of these conditions in the future.
Timepoint [1] 295664 0
Immediately before and after (pre- and post-) exposure to intervention or control infomaiton summary formats.
Secondary outcome [1] 316154 0
Secondary outcome 1: Decisional conflict (measured using the 10-item low literacy decisional conflict scale).
Timepoint [1] 316154 0
Immediately following exposure to intervention or control summary formats.
Secondary outcome [2] 316155 0
Secondary outcome 2: Confidence in decision-making (measured using 4 items from the decision self-efficacy scale).
Timepoint [2] 316155 0
Immediately following exposure to intervention or control summary formats.
Secondary outcome [3] 316156 0
Secondary outcome 3: Usability and accessibility of the written materials (semi-structured, self-administered questionnaire) (modified acceptability evaluation, Patient Decision Aids Research Group, Ottawa Hospital Research Institute)
Timepoint [3] 316156 0
Immediately following exposure to intervention or control summary formats.

Eligibility
Key inclusion criteria
Adults (18 years or more) who are the parents or primary caregivers of a child or children. Children are not required to be currently experiencing an acute respiratory illness for parents to be eligible to participate in the pilot study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People that are unable to adequately understand written or spoken English will be excluded.

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)
A Centre for Research in Evidence-Based Practice (CREBP) staff member who is independent of the project team will place and seal the allocated information summary format and corresponding questionnaire into a numbered opaque A4 envelope for each participant. Group allocation will be concealed to participants and interviewers until informed consent has been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomly assigned to one of 2 parallel groups to receive one of two formats – a decision aid (intervention) or a ‘fact sheet’ (control). Each participant will be randomly allocated written information for one of the three conditions (acute otitis media, acute bronchitis (cough) or sore throat). The randomisation sequence will be computer generated by a CREBP staff member who is independent of the project team. An independent CREBP staff member will place and seal the allocated written format for one condition and corresponding questionnaire into sequentially numbered opaque A4 envelopes. Group allocation will be concealed to participants and interviewers until voluntary consent has been obtained.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Quantitative data will be entered into IBM SPSS Statistics 20 for analysis. Results will be analysed descriptively. The primary analysis will be a comparison of the outcomes between the intervention and control groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291723 0
Government body
Name [1] 291723 0
Australian Commission on Safety and Quality in Health Care.
Address [1] 291723 0
GPO Box 5480
Sydney, NSW, 2001.
Country [1] 291723 0
Australia
Funding source category [2] 291724 0
Government body
Name [2] 291724 0
National Health and Medical Research Council.
Address [2] 291724 0
GPO Box 1421
Canberra, ACT, 2601.
Country [2] 291724 0
Australia
Primary sponsor type
University
Name
Centre for Research in Evidence-Based Practice, Bond University.
Address
Gold Coast, QLD, 4229.
Country
Australia
Secondary sponsor category [1] 290397 0
None
Name [1] 290397 0
Address [1] 290397 0
Country [1] 290397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293247 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 293247 0
Gold Coast, QLD, 4229.
Ethics committee country [1] 293247 0
Australia
Date submitted for ethics approval [1] 293247 0
06/05/2015
Approval date [1] 293247 0
10/06/2015
Ethics approval number [1] 293247 0
0000015179

Summary
Brief summary
Acute respiratory infections in children are one of the most common reasons for consulting in primary care. An antibiotic is prescribed in the majority of cases, despite high quality evidence that antibiotics provide marginal benefit for many common acute respiratory infections, which may be outweighed by exposure to common harms (such as diarrhoea, vomiting and rash) and development of antibiotic resistance - now a global public health crisis.

Shared decision making - which aims to elicit patients’ expectations, clarify misperceptions, and discuss the best available evidence for treatment benefits and harms - may enable clinicians and parents to choose appropriate treatment or management options, including the decision to not use an antibiotic. Decision aids are a tool that have been shown to improve communication between patients and their doctor, and their active participation in decision making.

Therefore, the aim of the current study is to develop and evaluate (pilot) decision aids about antibiotic use for common acute respiratory infections (middle ear infection, sore throat and acute cough).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59050 0
Mr Peter D Coxeter
Address 59050 0
Centre for Research in Evidence-Based Practice,
Bond University,
Gold Coast, QLD, 4229.
Country 59050 0
Australia
Phone 59050 0
+61 7 55951588
Fax 59050 0
Email 59050 0
pcoxeter@bond.edu.au
Contact person for public queries
Name 59051 0
Mr Peter D Coxeter
Address 59051 0
Centre for Research in Evidence-Based Practice,
Bond University,
Gold Coast, QLD, 4229.
Country 59051 0
Australia
Phone 59051 0
+61 7 55951588
Fax 59051 0
Email 59051 0
pcoxeter@bond.edu.au
Contact person for scientific queries
Name 59052 0
Mr Peter D Coxeter
Address 59052 0
Centre for Research in Evidence-Based Practice,
Bond University,
Gold Coast, QLD, 4229.
Country 59052 0
Australia
Phone 59052 0
+61 7 55951588
Fax 59052 0
Email 59052 0
pcoxeter@bond.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary