Clinical trial NCT04784286: Telemedicine Follow-up for Bariatric Surgery Patients: What Do Patients Prefer
Official title: Telemedicine Follow-up for Bariatric Surgery Patients: What Do Patients Prefer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Patients' preference of telemedicine or in-person assessment for post-operative care.
timeFrame: 30 day post-op
Secondary outcomes:
measure: Post-operative complication rates are similar between patients receiving telemedicine and standard post-operative clinic visits.
timeFrame: 30 day post-op
measure: Patients' out-of-pocket costs for attending telemedicine post-operative visits are less than attending standard clinic.
timeFrame: 30 day post-op
measure: Institutional costs needed to provide telemedicine visits are less than what is needed for standard clinic care.
timeFrame: 30 day post-op
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Elizabeth B Habermann, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: