|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
15 March 2021 |
|
Main ID: |
ISRCTN53670726 |
|
Date of registration:
|
07/01/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
An evaluation of medical students’ judgment-making of chronic lower back pain cases
|
|
Scientific title:
|
Evaluating the effectiveness of a biopsychosocial e-learning intervention on medical students’ and GP trainees’ clinical judgment-making regarding future risk of disability in patients with CLBP: Study protocol for a randomised controlled trial |
|
Date of first enrolment:
|
01/02/2015 |
|
Target sample size:
|
34 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN53670726 |
|
Study type:
|
Interventional |
|
Study design:
|
Single-blind randomised controlled trial (Other)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Ireland
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Christopher
Dwyer |
|
Address:
|
Centre for Pain Research
School of Psychology
Arts Millennium Building
National University of Ireland
-
Galway
Ireland |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Current GP Trainee or medical student (year 3-5)
Exclusion criteria: Do not meet the inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Chronic Lower Back Pain
Signs and Symptoms
Chronic Lower Back Pain
|
|
Intervention(s)
|
Participants are randomised to the intervention or waiting list control group to using a web-based password secured and encrypted data management system to ensure that the groups are balanced.
Intervention group: Participants in the intervention group will complete the e-learning Flags Approach to Clinical Judgment educational intervention, which involves watching an 18-minute video, with an active learning exercise included in the middle, developed to teach the fundamentals of the bio-psychosocial model via the Flags Approach.
Control group: Participants will wait in an adjacent room where they will be provided non-medically-related magazines to read at their leisure.
Both groups will complete the full battery of assessments immediately before (time 1) and after (time 2) the intervention. Controls are wait-listed and will be provided an opportunity to view the intervention video following completion of the research.
|
|
Primary Outcome(s)
|
1. Judgement is measured using online tools according to responses to fictional case studies after the intervention
2. Judgment speed (response time) is measured in milliseconds as the length of time from the moment a case appeared on screen until a response (i.e. identifying, from 1-10, future risk of disability) is clicked via the mouse
|
|
Secondary Outcome(s)
|
1. Flags Approach knowledge is assessed using a multiple choice question test immediately before and after the intervention
2. Biomedical/biopsychosocial approach to chronic lower back pain is measured using the pain attitudes & beliefs scale (PABS) immediately before and after the intervention
3. Empathy is measured using the interpersonal reactivity index (IRI) immediately before and after the intervention
|
|
Source(s) of Monetary Support
|
|
Health Research Board
|
|
Ethics review
|
Status:
Approval date:
Contact:
National University of Ireland Galway Research Ethics Committee, 15/05/2012, ref: 12-May-06
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/01/2018 |
|
URL:
|
|
|
|