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Enhancing the quality of information-sharing in primary care for children with respiratory tract infections
ISRCTN ISRCTN46104365
DOI 10.1186/ISRCTN46104365
ClinicalTrials.gov identifier
EudraCT number
Public title Enhancing the quality of information-sharing in primary care for children with respiratory tract infections
Scientific title
Acronym EQUIP - Enhancing the QUality of Information-sharing in Primary care
Serial number at source G106/1225
Study hypothesis To 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.
Lay summary Not provided at time of registration
Ethics approval East Wales Research Ethics Committee - Panel D, 11/01/2005, ref: 04/WSE04/109
Study design Cluster randomised controlled trial of the use of a new leaflet for parents on RTIs in children or usual practice.
Countries of recruitment United Kingdom
Disease/condition/study domain Respiratory Tract Diseases
Participants - inclusion criteria Subjects 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.
Participants - exclusion criteria 1. 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)
Anticipated start date 01/10/2005
Anticipated end date 30/09/2009
Status of trial Completed
Patient information material
Target number of participants 600
Interventions Intervention: 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.
Primary outcome measure(s) 1. 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 measure(s) No secondary outcome measures
Sources of funding Medical Research Council (MRC) G106/1225 (UK)
Trial website
Publications 2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18435857
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19640941
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24289324
Contact name Dr  Nick  Francis
  Address Department of General Practice
3rd Floor
Neuadd Meirionnydd
Heath Park
  City/town Cardiff
  Zip/Postcode CF14 4XN
  Country United Kingdom
  Email francisna@cardiff.ac.uk
Sponsor Cardiff University (UK)
  Address Research and Commercial Division
7th Floor
30-36 Newport Road
  City/town Cardiff
  Zip/Postcode CF24 0DE
  Country United Kingdom
  Email davieskp2@cardiff.ac.uk
Date applied 17/02/2006
Last edited 10/07/2014
Date ISRCTN assigned 12/04/2006
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