Bariatric Surgery Candidate Clinical Trial
— MARSOfficial title:
MOOC Applications Related to Shared Decision Making in Bariatric Surgery
What is this trial ? A major aim in surgery is to consent patients appropriately for procedures. This is known as shared decision making. It is the clinician's duty to provide patients with the information they need to weigh up the risks and benefits of surgery and come to an informed decision. The investigators have created a patient information course on bariatric surgery on a platform known as a Massive Open Online Course (MOOC). This platform will host the course and will involve videos, written material and a number of questions to test the patient's understanding. The course will be undertaken after patients have completed Tier 3 and been discussed at the Tier 4 MDT (multidisciplinary team) and before the first consultant appointment to discuss surgical options. If patients choose to participate, they will be randomly allocated to either undertake the patient information course or not to undertake the course and just undergo the standard consenting process. The actual timeline of the bariatric journey will be unaffected by participation in the trial. The consultant will not know of patient participation and patients will be asked not to disclose it. What is involved? The patients will have been invited by one of the researchers, via a telephone call, and they will have sent the patient information for them to read. Their appointments and schedule will remain the same in spite of participation. If they choose to take part and are randomly allocated to the MOOC group, a member of research team will issue them with details of how to access the course. Three to six weeks later the research team will contact them to test their recall over the phone of some important information about bariatric surgery. At six week's after the procedure, the research team will send a copy of the SDM Q9 (shared decision making Q9) questionnaire to complete and send back. This is a questionnaire that asks about satisfaction with the shared decision making process. If a patient is randomly allocated to the non MOOC group, they will also receive a recall test and a questionnaire after the consultant appointment in order to compare the two groups. What is the purpose of the trial? The purpose of this study is to find out if using a patient information course on a massive open online course platform (MOOC) is useful to help the consent process by testing patient recall and also to test satisfaction with the shared decision making process compared to what current practice is.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 20, 2025 |
Est. primary completion date | August 4, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients 18 years of age and over who are able to read and write - Patients who are eligible for tier 4 bariatric services having completed a Tier 3 weight loss programme which is standard criteria for eligibility to have bariatric surgery. Exclusion Criteria: - Patients without access to smartphone or a computer are also excluded - Patients who are having revisional bariatric surgery - Patients must also have a suitable grasp of the English language in order to participate. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
South Tyneside and Sunderland NHS Foundation Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recall testing | a mark out of ten for blinded recall testing by a questionnaire asked of all patients in the trial. Zero is the minimum and the maximum reached is 10. | 3-6 weeks after recruitment | |
Secondary | satisfaction with shared decision making process | validated SDM Q9 questionnaire, marked from 0 to 45, 45 being highest possible score and 0 being the lowest. Higher score indicates higher satisfaction with shared decision making process. | 6 weeks post operatively |
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