Contact information
Type
Scientific
Primary contact
Dr Vikram Jha
ORCID ID
Contact details
Bradford Hospitals NHS Trust
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
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v.jha@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8835
Study information
Scientific title
Patient involvement in education and training: a randomised cluster trial of a patient-led training programme to improve patient safety
Acronym
Study hypothesis
The study is a randomised cluster trial with control conducted in the former Yorkshire Deanery. In North and East Yorkshire and Northern Lincolnshire (NEYNL) Foundation school the intervention and control arm will run in parallel sessions, trainees and participants will be randomly assigned to either group on the day of teaching. In the West Yorkshire Foundation School, teaching takes place on two sites, one site will receive the intervention (Harrogate) and a second site will receive the control (Airedale). Participants will be allocated to either site pre-intervention based on their on-call rota.
Ethics approval
MREC approved (ref: 10/H1302/6)
Study design
Multicentre non-randomised observational prevention qualitative study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Health Services Research
Intervention
Control: Foundation Year 1 junior doctors will receive their standard mandatory patient safety training
Intervention: Foundation Year 1 junior doctors will listen to two patients talk about their experiences of a patient safety incident as part of their mandatory patient safety training
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Change attitudes and culture among the doctors, measured with the Attitudes to Patient Safety Questionnaire (APSQ)
Secondary outcome measures
In depth interviews with a purposive sample of ten trainees from each group, at 4 - 6 weeks following the teaching session
Overall trial start date
01/01/2010
Overall trial end date
30/11/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Foundation year one trainee doctors undertaking the patient safety module as part of their mandatory training in East and West Yorkshire.
2. Patients that have been involved in a patient safety incident in the NHS
3. Aged 18 years or older, either sex
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 438
Participant exclusion criteria
1. Trainee doctors - we anticipate that all those enrolled on the safety training module will be eligible to take part in the research study
2. Patients under the age of 18 years
3. Unable to give consent to participate
Recruitment start date
01/01/2010
Recruitment end date
30/11/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bradford Hospitals NHS Trust
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
NHS Bradford and Airedale (UK)
Sponsor details
Douglas Mill
Bowling Old Lane
Bradford
BD5 7JR
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Programme Grants for Applied Research
Alternative name(s)
NIHR Programme Grants for Applied Research, PGfAR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
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
Basic results (scientific)
Publication list
1. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21129179
2. 2013 results in https://www.ncbi.nlm.nih.gov/pubmed/23527865 (added 11/02/2019)
Publication citations
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Protocol
Winterbottom AE, Jha V, Melville C, Corrado O, Symons J, Torgerson D, Watt I, Wright J, A randomised controlled trial of patient led training in medical education: protocol., BMC Med Educ, 2010, 10, 90, doi: 10.1186/1472-6920-10-90.