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

NCT04784286 | Terminated

• 1 other identifier: 18-010144
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• 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?

  30 day post-op

Secondary Outcomes (3)

• Post-operative complication rates are similar between patients receiving telemedicine and standard post-operative clinic visits.

  30 day post-op

• Patients' out-of-pocket costs for attending telemedicine post-operative visits are less than attending standard clinic.

  30 day post-op

• Institutional costs needed to provide telemedicine visits are less than what is needed for standard clinic care.

  30 day post-op

Study Arms (2)

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.

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.

Other: In-Person 30-day post-op visit

Interventions

Telemedicine 30-day post-op visit 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.

Also known as: Patient Satisfaction

Telemedicine 30-day follow-up visit

In-Person 30-day post-op visit 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.

Also known as: Patient Satisfaction

In-person 30-day follow-up visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Elizabeth B Habermann, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The randomized assignments (2 arms) will be generated by an analyst/statistician using a Mayo Clinic statistical application. The research assistant/coordinator will issue the next in a series of sequentially numbered, sealed, opaque envelopes containing the group assignment. The envelope will have information regarding the treatment assignment and will be entered into a database by the study coordinator.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Services Research, College of Medicine

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: May 14, 2019
• Primary Completion: October 26, 2020
• Study Completion: October 26, 2020
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)