A randomised controlled trial to evaluate a novel CD-ROM learning package against the standard lecture - training system for research governance in the teaching of new researchers in an NHS Trust

ISRCTN	ISRCTN91640245
DOI	https://doi.org/10.1186/ISRCTN91640245
Secondary identifying numbers	N0054184076

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 12/10/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs H Rogers
Scientific

Clinical Trials Unit
The Cardiothoracic Centre
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised controlled trial to evaluate a novel CD-ROM learning package against the standard lecture - training system for research governance in the teaching of new researchers in an NHS Trust
Study objectives	Is the use of a CD-ROM teaching package more cost effective than traditional lecture methods of teaching Research Governance to new researchers?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Not Applicable: Education
Intervention	The purpose of this study is to determine whether a CD-ROM can provide education in research governance to new researchers as effectively but more cheaply and conveniently than routine lecture teaching. A CD-ROM teaching package has been produced that is identical to a Power point teaching presentation. Staff at the Cardiothoracic Centre - Liverpool NHS Trust who have research as part of their job description will be invited to attend a half day study day in the lecture theatre of the hospital and provided with an information sheet to decide if they wish to take part in the study or not. On arrival in the lecture theatre subjects will be asked to consent to the study. Those who do will be randomised by pre numbered envelopes prepared by the clinical governance department. 1. Those subjects randomised to lecture will remain in the lecture theatre and receive 2 hours of the power point presentation with hand outs and web site addresses so that they have identical information to the CD-ROM group. 2. Those randomised to CD-ROM will be provided with a disc containing the PowerPoint presentation, web links and copies of important documents. They will be able to use this at home or with assistance from the librarian in the library. All participants will be requested not to discuss source documents with other members of the research group. They will also be requested to return in 2 weeks time for a knowledge multichoice questionnaire and a satisfaction survey.
Intervention type	Other
Primary outcome measure	1. Cost effectiveness will be measured by cost per hour per attendee taking into account only direct costs, with the assumption that the CD-ROM will be used for the same length of time as the lecture. Subjects who do not attend the exam will be considered exam failures and their data will be included in the cost effectiveness. Subjects who attend the exam but obtain less than the 50% pass mark will also be considered exam failures. 2. Satisfaction with the teaching method will be analysed via Lickert scale questions from Price J 2005 and written responses to open ended questions.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2006
Completion date	01/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	30
Key inclusion criteria	Participants will be identified by obtaining lists of staff on Banding 6 & 7 with research as part of their job description. These staff will then be approached by letter also enclosing a study information sheet. Participants will be recruited and consented on attendance at the lecture theatre for the teaching session. Subject inclusion criteria: 1. Age > 18 years 2. Able to give informed consent 3. Research active 4. Employee of the Cardiothoracic Centre - Liverpool NHS Trust The sample size has been calculated to detect a £2.50 difference in cost using a 2 sample t test .at 90% power with a mean population wage of £ 20.46 and a standard deviation of 1.8. This will be calculated by taking the direct costs of subject wages per hour spent learning and the unit cost of the teaching method. This provides a sample size of 24 (12 in each arm of the study). To allow for drop outs and to obtain 24 evaluable questionnaires a total of 30 subjects will be enrolled.
Key exclusion criteria	1. Unable to take ½ day for teaching and follow-up 2. No access to computer 3. Involved in another study within the last 30 days
Date of first enrolment	01/04/2006
Date of final enrolment	01/06/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Trials Unit

Liverpool
L14 3PE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Cardiothoracic Centre Liverpool NHS Trust (UK), NHS R&D Support Funding

No information available

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

Editorial Notes

12/10/2017: No publications found, verifying study status with principal investigator.