Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784286
Status:
TERMINATED
Last Update Posted:
2021-03-05
First Post:
2021-03-03
Brief Title:
Telemedicine Follow-up for Bariatric Surgery Patients What Do Patients Prefer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Telemedicine Follow-up for Bariatric Surgery Patients What Do Patients Prefer
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Because of Covid-19 in-person visits were halted and telemedicine was used
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None