Video information versus approved leaflets - which is better to provide informed consent for flexible cystoscopy?
| ISRCTN | ISRCTN19254894 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19254894 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/06/2015
- Registration date
- 16/09/2015
- Last edited
- 13/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and Aims
This study is about whether it is better to teach patients about flexible cystoscopy (a camera test to look inside the bladder) with a leaflet or a video animation. Video information is used widely for consumer information outside healthcare, but has been slow to catch on in hospitals. Adult literacy in the population served by Guy's and St Thomas' Trust is poor. Having compared reading ability with the readability of existing leaflets, there is a concern that a large portion of our patients currently cannot access the information they need. We have chosen our most common invasive test to look at whether video information is better than leaflets at getting important information across to patients.
Who can participate?
Adult patients who are attending the Urology Centre at Guy's Hospital for their first flexible cystoscopy test. Patients will be free to withdraw from the study at any time and without giving a reason – this will not affect the standard of care they receive.
What does the study involve?
We will divide the patients in this study into two groups: one group will read a leaflet before their procedure, and one will watch an animation. Any patient giving informed consent to take part will first be placed by chance into either a leaflet group or an animation group before the procedure. This process is called randomisation. The aim is to try and ensure that the groups are as similar as possible. There will be a 50% chance of being placed in either group. Then the patients will read the leaflet or watch the video, complete a short set of questions and have the cystoscopy procedure. The whole process, including your procedure, should not take longer than one hour.
What are the possible benefits and risks of participation?
The information we collect will help us to provide information more clearly to our patients who need this test in future. Communicating information by video could be more effective than by leaflet, especially for patients who struggle to read, or need an interpreter, for children, and for those with a learning disability.
Some patients may find the video makes them nervous. However, it was first shown to expert doctors and patients, who made sure that this would not be beyond the normal anxiety felt by a patient having this test.
Where is the study run from?
The study has been set up by a research team at Guy's and St Thomas' NHS Foundation Trust and will be conducted at the Urology Centre, Guy's Hospital, with assistance from Angus Fitchie, medical student at King’s College London and under supervision of Mr Ben Challacombe, consultant urological surgeon and Dr John Withington, urology research fellow. Guy’s and St Thomas’ NHS Foundation Trust will act as sponsor for this study and assumes responsibility for governance of the study.
When is the study starting and how long is it expected to run for?
December 2014 to October 2015. It is anticipated that the recruitment period will begin in July 2015 and end in October 2015.
Who is funding the study?
It is not expected that this trial will generate any significant financial costs. Any minimal costs incurred will be covered by the Urology Centre at Guy’s.
Who is the main contact?
Mr Ben Challacombe, ben.challacombe@gstt.nhs.uk
Angus Fitchie, angus.fitchie@kcl.ac.uk
Contact information
Public
Urology Centre
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Public
Urology Centre
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 of outpatients attending urology clinic at Guy's Hospital, comparing information provision to patients in leaflet versus video animation format with a view to informed consent to flexible cystoscopy procedure |
| Study objectives | Information provision for informed consent to flexible cystoscopy by video animation is superior to that by trust-approved leaflet with regard to: 1) accessibility of information and 2) patient satisfaction. |
| Ethics approval(s) | East of England - Cambridge East Research Ethics Committee, 17/02/2016, ref: 16/EE/0036 |
| Health condition(s) or problem(s) studied | Patient information provision by video animation for flexible cystoscopy |
| Intervention | All patients attending Guy’s Urology Centre for their first flexible cystoscopy procedure will be approached upon arrival by a researcher in the clinical care team for recruitment into the trial, provided they meet the trial’s inclusion criteria. As this trial will evaluate how patients engage with information about a procedure, it is crucial that the patients recruited have no prior experience of flexible cystoscopy. Patients who express interest to participate after a short verbal explanation of the trial will be offered a Patient Information Sheet (PIS) and consent form, which they will read and complete (available on request). The researcher will be present to answer any questions at this point. The date that the PIS is given to the patient must documented in the patient’s notes. On offering informed consent to take part in the trial, patients will be randomised to either the leaflet or video animation arm of the trial (by a quick phone call to research nurse for access to the next number in a randomised sequence). Patients in the leaflet arm will be given a trust-approved information leaflet to read, and those allocated to the video animation arm will be shown the video by the researcher. Following viewing of either supplementary information source, the patients will be asked to complete a basic cystoscopy questionnaire, testing their knowledge about the procedure gained from the leaflet or video animation. Thereafter, the leaflet patients will be requested to fill out a leaflet satisfaction questionnaire, and the video animation patients will be requested to fill out a video animation satisfaction questionnaire. The final question in both of these questionnaires asks the patients to choose whether they would prefer a video animation or leaflet for information on the procedure in future. Finally the patients from both arms will have a chance to ask any questions they may have about the procedure to either the researcher or the clinician performing the cystoscopy, before undergoing the flexible cystoscopy itself. It is not expected that any patient involved will spend greater than one hour in the study in total. After reading the patient information and consent forms and discussing any questions with a member of the research team, it is felt that any potential participants would need no longer than the duration of that day’s cystoscopy list (up to three hours) to consider participation. This is due to the simple and unobjectionable nature of what is required of a patient in this study (reading a leaflet or watching a short video and answering a small number of questions). Verbal and written consent will be obtained on the patient consent form in the presence of a member of the research team. The participant’s right to withdraw from the study at any time and for any reason will be emphasised. |
| Intervention type | Other |
| Primary outcome measure | The final score on a questionnaire testing patient knowledge about flexible cystoscopy (after having viewed the information source) – this will assess accessibility of supplementary information. |
| Secondary outcome measures | Thefinal score on a questionnaire about patient satisfaction with regard to information source – this will determine patient preference for information in leaflet or animation format. |
| Overall study start date | 02/12/2014 |
| Completion date | 01/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Adult patients between the ages of 18 and 100 years old 2. Male or female (inclusive of patients of child-bearing age, contraception irrelevant) 3. Patients attending for a first flexible cystoscopy at Guy’s Urology Centre 4. Patients able to provide informed consent |
| Key exclusion criteria | 1. Patients less than 18 years old or greater than 100 years old 2. Patients with prior experience of flexible cystoscopy 3. Patients with severe visual impairment who could not watch the video animation 4. Patients unable to offer informed consent due to limited ability to communicate 5. Patients who cannot understand the information presented without an interpreter (including British Sign Language) when an appropriate interpreter is not present |
| Date of first enrolment | 01/07/2015 |
| Date of final enrolment | 01/10/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor information
Research organisation
R&D Department, 16th Floor Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Research organisation
Government organisation / Local government
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is the intended that the results of the study are published in peer-reviewed scientific journals and also disseminated by internal report and conference presentation. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/04/2018: No publications found, verifying study status with principal investigator.
29/03/2016: Ethics approval information added.
