ObesityNCT04784286
Telemedicine Follow-up for Bariatric Surgery Patients: What Do Patients Prefer
A study testing Telemedicine 30-day post-op visit and In-Person 30-day post-op visit in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a randomized clinical trial that will randomize bariatric patients undergoing laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass to receive either in-person or telemedicine post-operative follow-up within 30 days after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Telemedicine 30-day post-op visit and In-Person 30-day post-op visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2019to 26 Oct 2020
- 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 Having bariatric surgery; primary Roux-en Y gastric bypass or sleeve gastrectomy Be in the United States at the time of their 30-day follow-up Live 70 miles or further from Mayo Clinic downtown campus in Rochester, MN Access to WI-FI and electronic device (laptop, computer, tablet, smart phone, etc.) Willing to consent for the study
Who cannot join
- Patients < 18 years of age Be outside the United States at the time of their follow-up Undergoing revision of previous bariatric surgery Unable to speak English Unwilling or unable to provide consent for the study
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized clinical trial that will randomize bariatric patients undergoing laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass to receive either in-person or telemedicine post-operative follow-up within 30 days after surgery.
Read the detailed description
Our current bariatric practice: Bariatric surgery patients are expected to follow up with the bariatric surgery midlevel providers as well as with dietitians within 30-days after their bariatric procedure. The bariatric surgery midlevel providers are staffed and supported by our bariatric surgeons in case if they have questions or concerns. Patients do not get billed for post-operative visits within 90-days of global surgery period; the same global surgery rules apply to both in-person and telemedicine visits.
Patients are required to follow-up after surgery as part of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.
Adult (≥ 18 year-old) participants in the study will undergo primary Roux-en Y gastric bypass or sleeve gastrectomy and will randomized to telemedicine or in-person visit before their surgical procedure.
Patients who encounter unexpected intra-operative or post-operative complication or unexpected hospital course may not be offered telemedicine visits but will be included in our analysis. The performing surgeon will determine if a patient is illegible for telemedicine visit if unexpected course was encountered. However, analysis will be analysis to treat.
All participants will be contacted via telephone and will be surveyed about their post-operative care visits within 7-14 days after that visit, which is typically performed within 30-days after surgery. The survey will be developed in coordination with the Mayo Clinic Research Survey Center and will focus on the following aspects: baseline familiarity with technology, patients' satisfaction with the post-operative care they received, patients' preference of in-person vs telemedicine visits, patients' estimation of additional costs for their care outside of the direct medical costs, along with an open question that will ask patients to provide comments and feedback about their overall experience with their follow-up appointment.
- Conditions
- Obesity
- Being tested
- Telemedicine 30-day post-op visit, In-Person 30-day post-op visit
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine 30-day post-op visitOther
Also called Patient Satisfaction
Consented subjects randomized to the telemedicine visit arm will do their 30-day post-op visit via secure telemedicine video application through the Center of Connected Care. A survey will be asked via telephone about their post-op care visit, costs incurred, and feedback.
In-Person 30-day post-op visitOther
Also called Patient Satisfaction
Consented subjects randomized to the in-person visit arm will physically come to a clinical visit with the bariatric surgery midlevel providers. A survey will be asked via telephone about their post-op care visit, costs incurred, and feedback.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine 30-day follow-up visit | Active comparator | The Center for Connected Care will arrange for 30-day post-op telemedicine visits via a secured video application. When there is a telemedicine visit, the Center of Connected Care will connect the patient and then page the midlevel provider and dietitian after the electronic rooming process is complete \& the patient is ready.
A survey about post-operative care visits within 7-14 days after that visit. The survey will focus on the following aspects: baseline familiarity with technology, patients' satisfaction with the post-op care they received, patients' preference of in-person vs telemedicine visits, patients' estimation of additional costs for care outside of the direct medical costs, along with an open question asking for comments \& feedback about their overall experience with their follow-up appointment. Receives: Other: Telemedicine 30-day post-op visit |
| In-person 30-day follow-up visit | Active comparator | Standard practice of having bariatric surgery patients follow up with the bariatric surgery midlevel providers as well as with dietitians within 30-days after their bariatric procedure. The bariatric surgery midlevel providers are staffed and supported by our bariatric surgeons in case if they have questions or concerns.
Participants will be contacted via telephone and will be surveyed about their post-operative care visits within 7-14 days after that visit. The survey will focus on the following aspects: baseline familiarity with technology, patients' satisfaction with the post-operative care they received, patients' preference of in-person vs telemedicine visits, patients' estimation of additional costs for their care outside of the direct medical costs, along with an open question that will ask patients to provide comments and feedback about their overall experience with their follow-up appointment. Receives: Other: In-Person 30-day post-op visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' preference of telemedicine or in-person assessment for post-operative care.
This will be addressed by asking the following question in the survey:
How likely or unlikely would you be to accept an invitation to meet with your bariatric provider via video call from your home when you do not need new labs/imaging, your physician can review outside labs/imaging, and no physical exam/procedure is needed?
Measured: 30 day post-op
Secondary outcomes (3)
Post-operative complication rates are similar between patients receiving telemedicine and standard post-operative clinic visits.
Complication rates in both groups including unplanned readmission or re-operation
Measured: 30 day post-op
Patients' out-of-pocket costs for attending telemedicine post-operative visits are less than attending standard clinic.
Patients' estimated out-of-pocket costs of follow-up visits, including missed days of work, hotel stays and transportation
Measured: 30 day post-op
Institutional costs needed to provide telemedicine visits are less than what is needed for standard clinic care.
Compare institutional costs needed to provide telemedicine with those to provide standard post-operative care for bariatric patients.
Measured: 30 day post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start14 May 2019
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Why it stopped: Because of Covid-19, in-person visits were halted and telemedicine was used.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth B. Habermann, Mayo Clinic
- Investigators
- Elizabeth B Habermann, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784286
- Sponsor's protocol ID
- 18-010144
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All individual participant data will be deidentified by giving each consented subject a unique number/code before sharing with the other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Follow-up for Bariatric Surgery Patients: What Do Patients Prefer
- ClinicalTrials.gov ID
- NCT04784286
- Acronym / sponsor ID
- 18-010144
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of Covid-19, in-person visits were halted and telemedicine was used.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 5 Mar 2021 (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.
This is a randomized clinical trial that will randomize bariatric patients undergoing laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass to receive either in-person or telemedicine post-operative follow-up within 30 days after surgery.
Detailed description
Our current bariatric practice: Bariatric surgery patients are expected to follow up with the bariatric surgery midlevel providers as well as with dietitians within 30-days after their bariatric procedure. The bariatric surgery midlevel providers are staffed and supported by our bariatric surgeons in case if they have questions or concerns. Patients do not get billed for post-operative visits within 90-days of global surgery period; the same global surgery rules apply to both in-person and telemedicine visits.
Patients are required to follow-up after surgery as part of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.
Adult (≥ 18 year-old) participants in the study will undergo primary Roux-en Y gastric bypass or sleeve gastrectomy and will randomized to telemedicine or in-person visit before their surgical procedure.
Patients who encounter unexpected intra-operative or post-operative complication or unexpected hospital course may not be offered telemedicine visits but will be included in our analysis. The performing surgeon will determine if a patient is illegible for telemedicine visit if unexpected course was encountered. However, analysis will be analysis to treat.
All participants will be contacted via telephone and will be surveyed about their post-operative care visits within 7-14 days after that visit, which is typically performed within 30-days after surgery. The survey will be developed in coordination with the Mayo Clinic Research Survey Center and will focus on the following aspects: baseline familiarity with technology, patients' satisfaction with the post-operative care they received, patients' preference of in-person vs telemedicine visits, patients' estimation of additional costs for their care outside of the direct medical costs, along with an open question that will ask patients to provide comments and feedback about their overall experience with their follow-up appointment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Telemedicine 30-day follow-up visit | Active comparator | Other: Telemedicine 30-day post-op visitThe Center for Connected Care will arrange for 30-day post-op telemedicine visits via a secured video application. When there is a telemedicine visit, the Center of Connected Care will connect the patient and then page the midlevel provider and dietitian after the electronic rooming process is complete \& the patient is ready. A survey about post-operative care visits within 7-14 days after that visit. The survey will focus on the following aspects: baseline familiarity with technology, patients' satisfaction with the post-op care they received, patients' preference of in-person vs telemedicine visits, patients' estimation of additional costs for care outside of the direct medical costs, along with an open question asking for comments \& feedback about their overall experience with their follow-up appointment. |
| In-person 30-day follow-up visit | Active comparator | Other: In-Person 30-day post-op visitStandard practice of having bariatric surgery patients follow up with the bariatric surgery midlevel providers as well as with dietitians within 30-days after their bariatric procedure. The bariatric surgery midlevel providers are staffed and supported by our bariatric surgeons in case if they have questions or concerns. Participants will be contacted via telephone and will be surveyed about their post-operative care visits within 7-14 days after that visit. The survey will focus on the following aspects: baseline familiarity with technology, patients' satisfaction with the post-operative care they received, patients' preference of in-person vs telemedicine visits, patients' estimation of additional costs for their care outside of the direct medical costs, along with an open question that will ask patients to provide comments and feedback about their overall experience with their follow-up appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 18 years of age Having bariatric surgery; primary Roux-en Y gastric bypass or sleeve gastrectomy Be in the United States at the time of their 30-day follow-up Live 70 miles or further from Mayo Clinic downtown campus in Rochester, MN Access to WI-FI and electronic device (laptop, computer, tablet, smart phone, etc.) Willing to consent for the study
Key exclusion criteria (1 listed)
- Patients < 18 years of age Be outside the United States at the time of their follow-up Undergoing revision of previous bariatric surgery Unable to speak English Unwilling or unable to provide consent for the study
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 |
|---|---|---|
| Telemedicine 30-day post-op visitAlso: Patient SatisfactionConsented subjects randomized to the telemedicine visit arm will do their 30-day post-op visit via secure telemedicine video application through the Center of Connected Care. A survey will be asked via telephone about their post-op care visit, costs incurred, and feedback. | Other | Telemedicine 30-day follow-up visit |
| In-Person 30-day post-op visitAlso: Patient SatisfactionConsented subjects randomized to the in-person visit arm will physically come to a clinical visit with the bariatric surgery midlevel providers. A survey will be asked via telephone about their post-op care visit, costs incurred, and feedback. | Other | In-person 30-day follow-up visit |
Primary outcome
Patients' preference of telemedicine or in-person assessment for post-operative care.
Time frame: 30 day post-op
This will be addressed by asking the following question in the survey: How likely or unlikely would you be to accept an invitation to meet with your bariatric provider via video call from your home when you do not need new labs/imaging, your physician can review outside labs/imaging, and no physical exam/procedure is needed?
3 secondary outcomes
Post-operative complication rates are similar between patients receiving telemedicine and standard post-operative clinic visits.
Time frame: 30 day post-op
Patients' out-of-pocket costs for attending telemedicine post-operative visits are less than attending standard clinic.
Time frame: 30 day post-op
Institutional costs needed to provide telemedicine visits are less than what is needed for standard clinic care.
Time frame: 30 day post-op
Results and safety
The study was stopped early (reason given: Because of Covid-19, in-person visits were halted and telemedicine was used.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. All individual participant data will be deidentified by giving each consented subject a unique number/code before sharing with the other researchers.
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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.
Elizabeth B Habermann, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine 30-day post-op visit and In-Person 30-day post-op visit in people with Obesity, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Because of Covid-19, in-person visits were halted and telemedicine was used.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' preference of telemedicine or in-person assessment for post-operative care. (time frame: 30 day post-op). 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 5 Mar 2021.