Contact information
Type
Scientific
Primary contact
Dr Nick Francis
ORCID ID
Contact details
Department of General Practice
3rd Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4XN
United Kingdom
francisna@cardiff.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G106/1225
Study information
Scientific title
Acronym
EQUIP - Enhancing the QUality of Information-sharing in Primary care
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.
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Condition
Respiratory Tract Diseases
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
No secondary outcome measures
Overall trial start date
01/10/2005
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
600
Participant 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)
Recruitment start date
01/10/2005
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of General Practice
Cardiff
CF14 4XN
United Kingdom
Sponsor information
Organisation
Cardiff University (UK)
Sponsor details
Research and Commercial Division
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
davieskp2@cardiff.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) G106/1225 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Protocol
Francis NA, Hood K, Simpson S, Wood F, Nuttall J, Butler CC, The effect of using an interactive booklet on childhood respiratory tract infections in consultations: study protocol for a cluster randomised controlled trial in primary care., BMC Fam Pract, 2008, 9, 23, doi: 10.1186/1471-2296-9-23.
-
Results
Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J, Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial., BMJ, 2009, 339, b2885.
-
Results
Francis NA, Phillips R, Wood F, Hood K, Simpson S, Butler CC, Parents' and clinicians' views of an interactive booklet about respiratory tract infections in children: a qualitative process evaluation of the EQUIP randomised controlled trial., BMC Fam Pract, 2013, 14, 182, doi: 10.1186/1471-2296-14-182.