Condition category
Not Applicable
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
31/03/2011
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 Vikram Jha

ORCID ID

Contact details

Bradford Hospitals NHS Trust
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
v.jha@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8835

Study information

Scientific title

Acronym

Patient involvement in education and training: A randomised trial

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 measures

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

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

Patient

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

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

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)

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

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21129179

Publication citations

  1. 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.

Additional files

Editorial Notes