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Evaluation of decision aids for parents about the benefits and harms of antibiotic use for coughs and colds in children.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000843550
Enrollment
120
Registered
2015-08-13
Start date
2015-08-31
Completion date
2015-12-18
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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) re

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.

Sponsors

Centre for Research in Evidence-Based Practice, Bond University.
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

People that are unable to adequately understand written or spoken English will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 9, 2026