search
Back to results

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

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine 30-day post-op visit
In-Person 30-day post-op visit
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Telemedicine 30-day follow-up visit

In-person 30-day follow-up visit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
March 3, 2021
Last Updated
March 3, 2021
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT04784286
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Because of Covid-19, in-person visits were halted and telemedicine was used.
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
October 26, 2020 (Actual)
Study Completion Date
October 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Care ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine 30-day follow-up visit
Arm Type
Active Comparator
Arm Description
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.
Arm Title
In-person 30-day follow-up visit
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telemedicine 30-day post-op visit
Other Intervention Name(s)
Patient Satisfaction
Intervention Description
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
Intervention Name(s)
In-Person 30-day post-op visit
Other Intervention Name(s)
Patient Satisfaction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patients' preference of telemedicine or in-person assessment for post-operative care.
Description
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?
Time Frame
30 day post-op
Secondary Outcome Measure Information:
Title
Post-operative complication rates are similar between patients receiving telemedicine and standard post-operative clinic visits.
Description
Complication rates in both groups including unplanned readmission or re-operation
Time Frame
30 day post-op
Title
Patients' out-of-pocket costs for attending telemedicine post-operative visits are less than attending standard clinic.
Description
Patients' estimated out-of-pocket costs of follow-up visits, including missed days of work, hotel stays and transportation
Time Frame
30 day post-op
Title
Institutional costs needed to provide telemedicine visits are less than what is needed for standard clinic care.
Description
Compare institutional costs needed to provide telemedicine with those to provide standard post-operative care for bariatric patients.
Time Frame
30 day post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth B Habermann, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All individual participant data will be deidentified by giving each consented subject a unique number/code before sharing with the other researchers.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs