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

Sponsor
Mayo Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT04784286
Collaborator
(none)
24
1
2
17.4
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telemedicine 30-day post-op visit
  • Other: In-Person 30-day post-op visit
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized clinical trialRandomized clinical trial
Masking:
Double (Care Provider, Investigator)
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.
Primary Purpose:
Health Services Research
Official Title:
Telemedicine Follow-up for Bariatric Surgery Patients: What Do Patients Prefer
Actual Study Start Date :
May 14, 2019
Actual Primary Completion Date :
Oct 26, 2020
Actual Study Completion Date :
Oct 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: 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.
Other Names:
  • Patient Satisfaction
  • Active Comparator: 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.

    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.
    Other Names:
  • Patient Satisfaction
  • Outcome Measures

    Primary Outcome Measures

    1. Patients' preference of telemedicine or in-person assessment for post-operative care. [30 day post-op]

      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

    1. Post-operative complication rates are similar between patients receiving telemedicine and standard post-operative clinic visits. [30 day post-op]

      Complication rates in both groups including unplanned readmission or re-operation

    2. Patients' out-of-pocket costs for attending telemedicine post-operative visits are less than attending standard clinic. [30 day post-op]

      Patients' estimated out-of-pocket costs of follow-up visits, including missed days of work, hotel stays and transportation

    3. Institutional costs needed to provide telemedicine visits are less than what is needed for standard clinic care. [30 day post-op]

      Compare institutional costs needed to provide telemedicine with those to provide standard post-operative care for bariatric patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Elizabeth B Habermann, Ph.D., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Elizabeth B. Habermann, Professor of Health Services Research, College of Medicine, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04784286
    Other Study ID Numbers:
    • 18-010144
    First Posted:
    Mar 5, 2021
    Last Update Posted:
    Mar 5, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elizabeth B. Habermann, Professor of Health Services Research, College of Medicine, Mayo Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 5, 2021