Enhancing the quality of information-sharing in primary care for children with respiratory tract infections

ISRCTN ISRCTN46104365
DOI https://doi.org/10.1186/ISRCTN46104365
Secondary identifying numbers G106/1225
Submission date
17/02/2006
Registration date
12/04/2006
Last edited
10/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nick Francis
Scientific

Department of General Practice
3rd Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4XN
United Kingdom

Email francisna@cardiff.ac.uk

Study information

Study designCluster randomised controlled trial of the use of a new leaflet for parents on RTIs in children or usual practice.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeOther
Scientific title
Study acronymEQUIP - Enhancing the QUality of Information-sharing in Primary care
Study objectivesTo evaluate the use of a complex intervention, consisting of a novel 'interactive leaflet' and training in its use, in primary care consultations involving children with Respiratory Tract Infections (RTIs). The evaluation will examine the impact that use of the leaflet has on use of consultation behaviour (including re-consultation for the same illness episode and future consulting for respiratory tract infections over the following year), use of antibiotics, parental empowerment (as measured by an adaptation of the Patient Empowerment Instrument), length of time to recovery, and adverse events such as complications and hospitalisations. We will also conduct a cost-effectiveness evaluation and a process evaluation with clinicians involved in the trial.
Ethics approval(s)East Wales Research Ethics Committee - Panel D, 11/01/2005, ref: 04/WSE04/109
Health condition(s) or problem(s) studiedRespiratory Tract Diseases
InterventionIntervention: use of a new 'interactive' leaflet on respiratory tract infections by general practitioners within the consultation, and then provided to parents as a take-home resource.
Comparison: usual care.
Intervention typeOther
Primary outcome measure1. Re-consultation for same episode of illness
2. Antibiotic prescription for the presenting illness at any point in the 2 week follow-up period
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/10/2005
Completion date30/09/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit14 Years
SexBoth
Target number of participants600
Key inclusion criteriaSubjects aged 6 months to 14 years who have been ill for 7 days or less, and have been diagnosed by their GP as having acute respiratory tract infection. This will include children suspected of having both upper and lower respiratory tract infections, and viral or bacterial infections, and will include sore throat, otitis media and sinusitis.
Key exclusion criteria1. With suspected pneumonia
2. Who have been formally diagnosed with asthma or who are currently taking or in need of oral or inhaled steroids or inhaled bronchodilators
3. Judged to need immediate admittance to hospital or with serious/concerning features
4. With serious concomitant illness (i.e. malignancy, cystic fibrosis)
5. Whose carer is unable to comply with the study protocol
6. Who have been seen previously for this illness episode
7. Who have been previously recruited into the trial (each child can only be recruited into the trial once)
8. Have a sibling who has been recruited into the trial (each family can only be recruited into the trial once)
Date of first enrolment01/10/2005
Date of final enrolment30/09/2009

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Department of General Practice
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

Research and Commercial Division
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Email davieskp2@cardiff.ac.uk
ROR logo "ROR" https://ror.org/03kk7td41

Funders

Funder type

Research council

Medical Research Council (MRC) G106/1225 (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 24/04/2008 Yes No
Results article results 29/07/2009 Yes No
Results article results 01/12/2013 Yes No