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临床试验/NCT04023175
NCT04023175已完成不适用

In Office Versus Telemedicine Preoperative Visit: a Randomized Controlled Trial

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2019年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
2
主要终点
Patient Preoperative Preparedness

研究概览

简要总结

This is a randomized controlled trial evaluating in office versus telemedicine preoperative counseling visits based on patient preparedness for surgery and patient satisfaction.

详细描述

PRIMARY OBJECTIVE To determine whether preoperative telemedicine appointments are non-inferior to in-office visits based on patient preoperative preparedness in women undergoing pelvic surgery as measured by a preoperative preparedness survey.

SECONDARY OBJECTIVES

  1. Evaluate patient satisfaction using the S-CAHPS survey

  2. Calculate the duration of visit for patient (minutes)

  3. Calculate the duration of visit for provider (minutes)

  4. Estimate round trip travel distance from patient home to clinic (miles)

  5. Evaluate the number of office contacts from date of preoperative counseling to 6 weeks postoperatively.

  6. Patient initiated calls

  7. Nurse initiated calls

  8. Scheduled office visits

  9. Add on office visits

  10. Evaluate canceled, no-show, and late visits

  11. Calculate value proposition metrics for Atrium Health System

PREOPERATIVE PERIOD All consecutive patients planning to undergo pelvic surgery who require a preoperative visit will be identified, screened, and approached for participation in the study. Participants who do not meet the inclusion and exclusion criteria will be considered screen failures. Screen failures will be captured and the cause for screen failure will be documented.

研究设计

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

入排标准

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

入选标准

  • Females age 18 and greater
  • Visit location in North Carolina
  • Planning to undergo pelvic surgery at Mercy Hospital or One Day Surgery Center
  • Scheduled for enhanced recovery perioperative protocol
  • Require a preoperative visit
  • Access to internet and a virtual visit capable device
  • Telephone access

排除标准

  • Non-English speaking
  • Inability to provide consent/decisionally impaired
  • Auditory impairment
  • Required preoperative in-office procedure such as endometrial biopsy

结局指标

主要结局

Patient Preoperative Preparedness

时间窗: 1-7 days

To determine whether preoperative telemedicine appointments are non-inferior to in-office visits based on patient preoperative preparedness in women undergoing pelvic surgery as measured by a preoperative preparedness survey. Preoperative Preparedness Questionnaire ranges from 11 to 66 points with higher scores equaling greater patient preparedness.

次要结局

  • Patient Satisfaction(2 week postoperative visit)
  • Round Trip Travel Distance(at preoperative visit (1-30 days prior to surgery))
  • Travel Time(1 day of a preoperative visit.)
  • Office Contacts, Total Scheduled In-person Visits(perioperative time period, up to approximately 10 weeks)
  • Postoperative Patient Initiated Phone Calls.(6 weeks postoperatively)
  • Duration of Visit(at preoperative visit (1-30 days prior to surgery))
  • Postoperative Add on In-person Visits.(6 weeks postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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