Condition category
Respiratory
Date applied
17/02/2006
Date assigned
12/04/2006
Last edited
10/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes