MOOC Applications Related to Shared Decision Making in Bariatric Surgery (MARS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bariatric Surgery Candidate; Informed Consent; Shared Decision Making
• Intervention / Treatment: Other: course (MOOC) patient education; Other: standard patient consent process

Detailed Description

The consenting process is not merely signing a form to allow an intervention or procedure to happen but is a process that allows the sharing of information regarding the procedure which concerns it's benefits, risks and alternatives.

Shared decision making can therefore be defined as a two way process that allows patients to express their preferences and opinions regarding pros, cons and alternatives to a particular procedure and allows the clinician to explain these pros, cons and alternatives on an individual basis. The Royal College of Surgeons has produced guidelines on shared decision making and consent, highlighting the paradigm shift that has occurred in the last ten years in this regard from what was traditionally a more paternalistic unidirectional approach. The College guidelines go further in recommending clinicians to encourage patients to seek web based and other information.

Despite this and the favourable view of both clinicians and patients towards shared decision making, it is clear that it is still in its infancy as highlighted in a 2018 systematic review by de Mik et al. This systematic review of thirty two studies highlights a need for further research with regards to interventions to improve shared decision making. Moreover, reviews from the NHS litigation authority claims against 11 surgical specialties over a ten year period revealed that failure to adequately consent was one of the three leading causes of claim with an estimated £1.5 billion paid out to claimants from 2004 to 2014. It is in the clinician's and patient's benefit for the decision making process to be robust and adequate. It is clear the shared decision making process needs to evolve in practice and where researchers of this study feel Massive Open Online Courses (MOOCs) can play a role.

Massive Open Online Courses have existed as a disruptor in the education sector and allow short courses to a large unrestricted and undifferentiated number of students, on a flexible basis on a wide variety of subjects. Courses are considered more democratic and accessible than traditional higher education courses as they are more inclusive, largely have no pre-requisites and usually free of charge from a range of higher education institutions. MOOCs can also reduce the need for human capital, allow for templates for creation of further courses/patient decision aids and reduce costs of information dissemination. They are also more sustainable and interactive than traditional patient leaflets, can be updated easily and usually involve small tests and certificates as proof of completion as well as being more environmentally friendly.

Thus the trial aims to cover two main unexplored concepts. The first is the feasibility of engaging patients and clinicians in MOOC creation for bariatric surgery. The second is trialing the MOOC in terms of utility as a patient decision aid versus traditional methods of patient information dissemination, which in the researcher's case is a patient leaflet and traditional consenting process. Utility would be investigated by means of ability to recall information and also patient satisfaction with the process using a validated questionnaire.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aya Musbahi, MBCHB MBA FRCS; Phone Number: 00447588360182; Email: musbahiaya@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOOC group; If a patient chooses to take part and is 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 them a copy of the SDM Q9 questionnaire to complete and send back. This is a questionnaire that asks about satisfaction with the shared decision making process.	Other: course (MOOC) patient education; this is a massive open online course created by us for patient education. Patients will be given a login and password to access the MOOC from their own computer. The MOOC has 3.5 hours of content and patients will be given 3 weeks to complete.
Active Comparator: non MOOC group; 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.	Other: standard patient consent process; standard consenting and shared decision making in the clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: South Tyneside and Sunderland NHS Foundation Trust

Publications and helpful links

Helpful Links

• this is the MOOC the team have created in a prototype form

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): August 4, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 322726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No