Enhancing the quality of information-sharing in primary care for children with respiratory tract infections
| ISRCTN | ISRCTN46104365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46104365 |
| Protocol serial number | G106/1225 |
| Sponsor | Cardiff University (UK) |
| Funder | Medical Research Council (MRC) G106/1225 (UK) |
- 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
Scientific
Department of General Practice
3rd Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4XN
United Kingdom
| francisna@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial of the use of a new leaflet for parents on RTIs in children or usual practice. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | EQUIP - Enhancing the QUality of Information-sharing in Primary care |
| Study objectives | 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(s) | East Wales Research Ethics Committee - Panel D, 11/01/2005, ref: 04/WSE04/109 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Re-consultation for same episode of illness |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 600 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Department of General Practice
Cardiff
CF14 4XN
United Kingdom
CF14 4XN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/07/2009 | Yes | No | |
| Results article | results | 01/12/2013 | Yes | No | |
| Protocol article | protocol | 24/04/2008 | Yes | No |
