Telemedicine Follow-up for Bariatric Surgery Patients: What Do Patients Prefer

NCT ID: NCT04784286

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-14
• Study Completion Date: 2020-10-26

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Telemedicine 30-day follow-up visit

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.

Group Type: ACTIVE_COMPARATOR

Telemedicine 30-day post-op visit

Intervention Type: OTHER

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 follow-up visit

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.

Group Type: ACTIVE_COMPARATOR

In-Person 30-day post-op visit

Intervention Type: OTHER

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.

Interventions

Telemedicine 30-day post-op visit

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.

Intervention Type: OTHER

In-Person 30-day post-op visit

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.

Intervention Type: OTHER

Other Intervention Names

Patient Satisfaction; Patient Satisfaction

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth B. Habermann

Professor of Health Services Research, College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth B Habermann, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-010144

Identifier Type: -

Identifier Source: org_study_id