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临床试验/NCT05678179
NCT05678179已完成不适用

Randomized Pilot Study Investigating the Feasibility and Acceptability of Utilizing Telehealth for Increasing Access to Bariatric Surgery

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
50
试验地点
2
主要终点
Telehealth Acceptability

研究概览

简要总结

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.

详细描述

Goals and Objectives

Study participants will be randomized to either a Telehealth treatment group where greater than 50% of visits are conducted via telehealth and testing is completed where the patient resides or to a F2F treatment group. Outcomes will include feasibility and patient acceptability of telehealth visits, adherence to required program visits, program retention, time to surgery, surgery completion, and payment parity data.

Specific aim 1 (primary): The primary aim is to assess the feasibility and acceptability of telehealth for increasing access to bariatric surgery and compare outcomes to patients who receive F2F visits. Feasibility and acceptability were selected as the primary outcomes for this pilot trial because the efficacy of any program is contingent on its ability to be implemented by providers and its acceptability to patients. Hypothesis: The Telehealth treatment group (> 50% of pre-surgery visits telehealth and testing performed locally) will be feasible to implement as evidenced by our ability to recruit and retain participants and acceptable to participants as evidenced by self-report of satisfaction with the program, adherence to required visits, program retention, time to surgery, and completion of surgery. We hypothesize that when comparing the Telehealth and F2F treatment groups, there will be no clinically meaningful differences regarding outcome variables.

Specific aim 2 (secondary): A secondary aim is to compare payment parity between Telehealth and F2F treatment groups. Hypothesis: Telehealth and F2F visits will be similarly reimbursed for bariatric visits.

Study Participants:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Telehealth Acceptability

时间窗: After each provider visit pre-surgery

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.

Telehealth Feasibility

时间窗: Pre-surgery

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

次要结局

  • Insurance Payer Parity(Pre-surgery)
  • Program Adherence(After each provider visit pre-surgery)
  • Time to Surgery(Measured date of surgery.)
  • Program Retention and Surgery Completion(Pre-surgery)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gretchen E. Ames

Principal Investigator

Mayo Clinic

研究点 (2)

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