Contact information
Type
Scientific
Primary contact
Dr Paul Kinnersley
ORCID ID
Contact details
Department of Primary Care and Public Health
Floor 3
Neuadd Meirionydd
Heath Park
Cardiff
CF14 4XN
United Kingdom
+44 29 20687638
kinnersley@cf.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 3/January 2009
Study information
Scientific title
A randomised controlled trial of a Question Prompt Sheet for patients attending an epilepsy clinic
Acronym
QPS Study
Study hypothesis
To identify whether for patients presenting to an epilepsy clinic use of a question prompt sheet leads to an increase in patients' perceptions of clinician empathy.
Ethics approval
North West Wales Ethics Committee, January 2009, ref: 07/WNo01/42
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Epilepsy
Intervention
The intervention is a Question Prompt sheet. The Prompt sheet briefly explains to patients that it may be helpful for them to consider what questions they want to ask at their consultation before they come to the clinic. It will encourage them to identify questions and to ask these in their consultation. It will provide examples of 'frequently asked questions' that patients may want to ask. The Prompt sheet will be piloted in advance to ensure readability. In addition, the clinicians will receive three one hour training sessions on general communication skills and answering patients' questions.
Both intervention and control patients will get a package providing general information about the epilepsy clinic.
The study materials will be posted to patients two weeks before their appointment at the clinic. Data will be collected when the patients consult and at four weeks after their consultation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Patient perception of clinician empathy, measured immediately after consultation.
Secondary outcome measures
1. Patient anxiety, measured with the Short Form Spielberger State Anxiety Scale before, immediately after and 4 weeks after the consultation
2. Patient satisfaction, measured immediately after the consultation
3. Patient enablement, measured 4 weeks after the consultation
4. Patient quality of life, measured using the QOL in Epilepsy Scale 4 weeks after the consultation
Overall trial start date
01/04/2009
Overall trial end date
01/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged 16 years and over (either sex) attending the epilepsy clinic
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 participants
Participant exclusion criteria
1. On attending the clinic, they appear unable to understand the study materials (in English or Welsh)
2. Too ill to take part in the study
Recruitment start date
01/04/2009
Recruitment end date
01/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care and Public Health
Cardiff
CF14 4XN
United Kingdom
Sponsor information
Organisation
Cardiff and Vale NHS Trust (UK)
Sponsor details
University Hospital of Wales
Heath Park
Cardiff
CF14 4XN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
UCB Pharma Ltd (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