MOOC Applications Related to Shared Decision Making in Bariatric Surgery

NCT06104137 | Unknown

• 1 other identifier: 322726
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bariatric Surgery Candidate; Shared Decision Making; Informed Consent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• satisfaction with shared decision making process

  6 weeks post operatively

Study Arms (2)

MOOC group

EXPERIMENTAL

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

non MOOC group

ACTIVE COMPARATOR

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

Interventions

course (MOOC) patient education OTHER

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.

MOOC group

standard patient consent process OTHER

standard consenting and shared decision making in the clinic

non MOOC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Tyneside and Sunderland NHS Foundation Trust: lead

Related Links

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

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Aya Musbahi, MBCHB MBA FRCS

CONTACT

00447588360182; musbahiaya@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomisation Method and Blinding Patients who are eligible and consented to participate in the study will be randomised to either the trial group or the control group with use of the sealed envelope method. The randomization will be blocked with use of random permuted blocks in groups of two, four, or six to help ensure that the groups are balanced. A piece of paper that has the phrase "MOOC" or "Control" will be placed in- side an envelope. MOOC patients will have the login and password in the envelope for access.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blinded RCT The study design is a randomised clinical trial with two arms. The trial will be double blinded to the consultant surgeon seeing them in clinic and to the assessor of recall but not blinded to the patient. Power calculations showed that to detect an improvement of 20% in the primary outcome measure of recall in the experiment group, with a two-sided 5% significance level and a power of 80% and a drop out rate of 10%, a sample size of 40 patients per arm is necessary.

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: October 27, 2023
• Study Start: November 1, 2023
• Primary Completion: August 4, 2025
• Study Completion: December 20, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share