NCT06104137: MARS

MOOC Applications Related to Shared Decision Making in Bariatric Surgery

Status unknown NA Last updated 27 October 2023

What this trial tests

NA trial testing course (MOOC) patient education in Bariatric Surgery Candidate in 80 participants. Status unknown.

Timeline

1 November 2023

Primary endpoint
4 August 2025

20 December 2025

Quick facts

Lead sponsor	South Tyneside and Sunderland NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	80
Start date	1 November 2023
Primary completion	4 August 2025
Estimated completion	20 December 2025

Drugs / interventions tested

• course (MOOC) patient education
• standard patient consent process

Conditions studied

• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →
• Shared Decision Making — all drugs for Shared Decision Making →
• Informed Consent — all drugs for Informed Consent →

Sponsor

South Tyneside and Sunderland NHS Foundation Trust

Who can join

18 and older, any sex, with Bariatric Surgery Candidate or Shared Decision Making. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.