Patient involvement in education and training: a randomised cluster trial of a patient-led training programme to improve patient safety

ISRCTN	ISRCTN94241579
DOI	https://doi.org/10.1186/ISRCTN94241579
Secondary identifying numbers	8835

Submission date: 21/10/2010
Registration date: 21/10/2010
Last edited: 11/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Vikram Jha
Scientific

Bradford Hospitals NHS Trust
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Email	v.jha@leeds.ac.uk

Study information

Study design	Multicentre non-randomised observational prevention qualitative study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Prevention
Scientific title	Patient involvement in education and training: a randomised cluster trial of a patient-led training programme to improve patient safety
Study objectives	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(s)	MREC approved (ref: 10/H1302/6)
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2010
Completion date	30/11/2012

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 438
Key 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
Key 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
Date of first enrolment	01/01/2010
Date of final enrolment	30/11/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bradford Hospitals NHS Trust

Bradford
BD9 6RJ
United Kingdom

Sponsor information

NHS Bradford and Airedale (UK)
Government

Douglas Mill
Bowling Old Lane
Bradford
BD5 7JR
United Kingdom

Website	http://www.bradfordairedale-pct.nhs.uk

Funders

Funder type

Government

Programme Grants for Applied Research
Government organisation / National government

Alternative name(s): NIHR Programme Grants for Applied Research, PGfAR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	03/12/2010		Yes	No
Results article	results	01/09/2013	11/02/2019	Yes	No

Editorial Notes

11/02/2019: Publication reference added.
29/08/2018: No publications found, verifying study status with principal investigator.