Condition category
Not Applicable
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
08/09/2015
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

Mrs H Rogers

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0054184076

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2006

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

30

Participant 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

Recruitment start date

01/04/2006

Recruitment end date

01/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit
Liverpool
L14 3PE
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

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

Publication citations

Additional files

Editorial Notes