The Feasibility and Acceptability of Utilizing Telehealth for Increasing Access to Bariatric Surgery

NCT05678179 | Completed

• 1 other identifier: 22-011275
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Bariatric surgery is recommended as the most efficacious treatment for patients living with obesity (body mass index \[BMI; kg/m2\] \> 40; or BMI 35-39.9 with related medical conditions). Adoption of telehealth services offers an opportunity to reduce barriers and expand access to high quality specialty care for patients considering bariatric surgery for treatment of obesity. Two important advances in telehealth services occurred during the COVID-19 public health emergency. Specifically, the patient's home is now the origin site for all services where patients are no longer required to travel to a designated telehealth location, and the use of telehealth has expanded to multidisciplinary health care teams. Our bariatric surgery care team has gained valuable experience using a combination of face-to-face (F2F) and telehealth visits for multidisciplinary evaluation in preparation for bariatric surgery since March 2020. Appointments that do not require a physical exam like nutrition, psychology, group education, and medical visits after completion of pre-operative testing are particularly amenable to telehealth services. Increased use of telehealth has the potential to reduce barriers to care (e.g., lack of access to accredited bariatric surgery treatment centers, extended travel time for multiple pre-surgery appointments), increase adherence to required program visits, and increase patient satisfaction. Patient satisfaction variables may include reduced time away from work, flexibility in appointment scheduling, and reduced physical demands of multiple F2F visits. A necessary first step is to demonstrate that the protocol outlined below can be successfully implemented in a real-world clinical setting and is deemed acceptable by patients preparing for bariatric surgery.

Conditions

Telehealth; Face-2-Face (F2F)

Outcome Measures

Primary Outcomes (2)

• Telehealth Feasibility

  Telehealth feasibility will be measured by whether \>50% of telehealth group visits are conducted virtually, and testing is performed locally.

  Pre-surgery

• Telehealth Acceptability

  Acceptability will be measured by a questionnaire constructed by the authors to capture the acceptability of participation in the Telehealth treatment group compared to the F2F condition. Responses to Likert scale (9-points) items will be summarized as the mean of all items. The treatment will be considered acceptable if greater than 50% of participants rate satisfaction with a mean score of 6 or greater (e.g., satisfied to extremely satisfied). The survey will be administered to all participants via email using Qualtics.

  After each provider visit pre-surgery

Secondary Outcomes (4)

• Program Adherence

  After each provider visit pre-surgery

• Time to Surgery

  Measured date of surgery.

• Program Retention and Surgery Completion

  Pre-surgery

• Insurance Payer Parity

  Pre-surgery

Study Arms (2)

Telehealth

EXPERIMENTAL

Behavioral: Telehealth

In Person (Face-2-Face)

ACTIVE COMPARATOR

Behavioral: In Person (Face-2-Face)

Interventions

Telehealth BEHAVIORAL

Patients will participate in standard clinical practice for bariatric surgery preparation with 50% of visits occurring via telehealth.

Telehealth

In Person (Face-2-Face) BEHAVIORAL

Patients will participate in standard clinical practice for bariatric surgery preparation with face-2-face clinic visits.

In Person (Face-2-Face)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet medical necessity criteria for primary bariatric surgery and reside in FL, (2) can participate fully in all aspects of the protocol and keep scheduled appointments, (3) have in home access to telehealth (4) provide written informed consent, (5) are willing to accept randomization, and (6) have a primary care doctor to facilitate local testing in preparation for bariatric surgery.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients seeking bariatric surgery will be randomized to a Telehealth Treatment Group or a Face-to-Face (F2F) treatment group.

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 10, 2023
• Study Start: February 6, 2023
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)