Bariatric Surgery CandidateMARSNCT06104137
MOOC Applications Related to Shared Decision Making in Bariatric Surgery
A study testing course (MOOC) patient education and standard patient consent process in people with Bariatric Surgery Candidate and Shared Decision Making, run by South Tyneside and Sunderland NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Shared Decision Making, Informed Consent
- What is being tested?
- course (MOOC) patient education and standard patient consent process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- course (MOOC) patient education, standard patient consent process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
course (MOOC) patient educationOther
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.
standard patient consent processOther
standard consenting and shared decision making in the clinic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: standard patient consent process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 weeks after recruitment
Secondary outcomes (1)
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.
Measured: 6 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion4 Aug 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104137
- Sponsor's protocol ID
- 322726
- Acronym
- MARS
- Status last verified
- Oct 2023
- First submitted
- 18 Apr 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOOC Applications Related to Shared Decision Making in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06104137
- Acronym / sponsor ID
- MARS / 322726
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 4 Aug 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MOOC group | Experimental | Other: course (MOOC) patient educationIf 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. |
| non MOOC group | Active comparator | Other: standard patient consent processIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| course (MOOC) patient educationthis 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. | Other | MOOC group |
| standard patient consent processstandard consenting and shared decision making in the clinic | Other | non MOOC group |
Primary outcome
recall testing
Time frame: 3-6 weeks after recruitment
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.
1 secondary outcome
satisfaction with shared decision making process
Time frame: 6 weeks post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- this is the MOOC the team have created in a prototype formLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing course (MOOC) patient education and standard patient consent process in people with Bariatric Surgery Candidate and Shared Decision Making, run by South Tyneside and Sunderland NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Musbahi, MBCHB MBA FRCS (00447588360182, musbahiaya@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recall testing (time frame: 3-6 weeks after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.