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低风险手术患者出院后虚拟访视的随机非劣效性临床试验。

Postdischarge Virtual Visits for Low-risk Surgeries: A Randomized Noninferiority Clinical Trial.

机构信息

Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.

Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, North Carolina.

出版信息

JAMA Surg. 2021 Mar 1;156(3):221-228. doi: 10.1001/jamasurg.2020.6265.

DOI:10.1001/jamasurg.2020.6265
PMID:33439221
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7807392/
Abstract

IMPORTANCE

Postdischarge video-based virtual visits are a growing aspect of surgical care and have dramatically increased in the setting of the coronavirus disease 2019 (COVID-19) pandemic.

OBJECTIVE

To evaluate the outcomes of all-cause 30-day hospital encounter proportion among patients who have a postdischarge video-based virtual visit follow-up compared with in-person follow-up.

DESIGN, SETTING, AND PARTICIPANTS: Randomized, active, controlled noninferiority trial in an urban setting, including patients from a small community hospital and a large, tertiary care hospital. Patients who underwent minimally invasive appendectomy or cholecystectomy by a group of surgeons who cover emergency general surgery at these 2 hospitals were included. Patients undergoing elective and nonelective procedures were included.

INTERVENTIONS

Patients were randomized in a 2:1 fashion to video-based virtual visit or in-person visit.

MAIN OUTCOMES AND MEASURES

The primary outcome is the percentage of patients with 30-day hospital encounter, and we hypothesized that there would not be a significant increase in the 30-day hospital encounter proportion for patients who receive video-based virtual postdischarge care compared with patients who receive standard (in-person) care. Hospital encounter includes emergency department visit, observation, or inpatient admission.

RESULTS

A total of 1645 patients were screened; 289 patients were randomized to the virtual group and 143 to the in-person group. Fifty-three patients crossed over to the in-person follow-up group. The percentage of patients who had a hospital encounter was noninferior for virtual visits (12.8% vs 13.3% for in-person, Δ 0.5% with 1-sided 95% CI, -∞ to 5.2%). The amount of time patients spent with the clinician (mean of 8.4 minutes virtual vs 7.8 minutes in-person; P = .30) was not different, but the median overall postoperative visit time was 27.5 minutes shorter (95% CI, -33.5 to -24.0).

CONCLUSIONS AND RELEVANCE

Postdischarge video-based virtual visits did not increase hospital encounter proportions and provided shorter overall time commitment but equal time with the surgical team member. This information will help surgeons and patients feel more confident in using video-based virtual visits.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03258177.

摘要

重要性

基于视频的虚拟就诊是外科护理中日益重要的一部分,在 2019 年冠状病毒病(COVID-19)大流行期间,这种就诊方式的数量大幅增加。

目的

评估与面对面随访相比,接受基于视频的虚拟就诊的患者在出院后 30 天内发生任何原因的医院就诊比例。

设计、设置和参与者:在城市环境中进行的一项随机、主动、对照非劣效性试验,纳入了来自一家小型社区医院和一家大型三级保健医院的患者。接受一组覆盖这两家医院急诊普外科手术的外科医生进行微创阑尾切除术或胆囊切除术的患者被纳入研究。纳入接受择期和非择期手术的患者。

干预措施

患者以 2:1 的比例随机分配至基于视频的虚拟就诊或面对面就诊。

主要结局和测量指标

主要结局是 30 天内医院就诊的患者比例,我们假设与接受标准(面对面)护理的患者相比,接受基于视频的虚拟出院后护理的患者在 30 天内医院就诊比例不会显著增加。医院就诊包括急诊就诊、观察或住院治疗。

结果

共筛选了 1645 名患者;289 名患者被随机分配至虚拟组,143 名患者被随机分配至面对面组。53 名患者交叉至面对面随访组。虚拟就诊的患者发生医院就诊的比例不劣于面对面就诊(12.8%比 13.3%,单侧 95%CI,-∞至 5.2%)。患者与临床医生的时间(虚拟就诊平均 8.4 分钟,面对面就诊 7.8 分钟;P = .30)无差异,但总体术后就诊时间中位数缩短了 27.5 分钟(95%CI,-33.5 至-24.0)。

结论和相关性

出院后基于视频的虚拟就诊并未增加医院就诊比例,并且总体时间投入较短,但与外科团队成员的时间相同。这些信息将帮助外科医生和患者更有信心使用基于视频的虚拟就诊。

试验注册

ClinicalTrials.gov 标识符:NCT03258177。