Department of Surgery, Perelman School of Medicine of the University of Pennsylvania, Philadelphia.
Department of Surgery, Center for Surgery and Health Economics, Philadelphia, Pennsylvania.
JAMA Netw Open. 2024 Oct 1;7(10):e2438137. doi: 10.1001/jamanetworkopen.2024.38137.
Socially vulnerable patients with symptomatic cholelithiasis are more likely to face barriers to accessing surgical care. This barrier to access can lead to delays in treatment, the need for emergent cholecystectomy, and worse outcomes.
To determine the effectiveness of telemedicine vs in-person surgical consultation on access to elective cholecystectomy in socially vulnerable populations and to evaluate the association of scheduling navigation with access to elective cholecystectomy in these populations.
DESIGN, SETTING, AND PARTICIPANTS: This pilot randomized clinical trial conducted in a single academic center enrolled 60 adults from February 1, 2023, to February 21, 2024, with 3-month follow-up of clinical outcomes. Data were also collected retrospectively on a comparison group of 32 patients referred from June 30 to December 29, 2022. Adults with social vulnerability, such as being non-White or Hispanic or having nonprivate insurance or low income, with a diagnosis of symptomatic cholelithiasis and referral for outpatient surgical consultation were included.
All trial participants were randomized to the telemedicine or in-person surgical consultation group, and received professional scheduling navigation. The latter intervention was compared with a historical cohort without navigation assistance.
The primary outcome was completion of outpatient surgical consultation. Secondary outcomes included receipt of treatment and operative urgency.
The trial enrolled 60 participants (30 per arm). Their mean (SD) age was 48.2 (18.2) years, 50 (83.3%) were female, 2 (3.3%) were Asian, 39 (65.0%) were Black, 8 (13.3%) were Hispanic, 11 (18.3%) were White, and 41 (68.3%) had no private insurance. The historical patient cohort included 32 participants (mean [SD] age, 45.9 [3.2] years; 27 [84.4%] female; 3 [9.4%] Asian, 15 [46.9%] Black, 10 [31.3%] Hispanic, and 6 [18.8%] White; and 18 [56.3%] without private insurance). In total, 18 trial participants assigned to telemedicine (60.0%) completed surgical consultations compared with 23 trial participants assigned to in-person visits (76.7%; P = .17). For telemedicine participants who underwent cholecystectomy, 3 of 7 (42.9%) underwent emergent cholecystectomy compared with 0 of 14 (0%) participants with in-person consultations (P = .03). Of 30 trial participants who received scheduling navigation, 23 (76.7%) completed surgical consultations compared with 15 of 32 patients in the historical cohort who did not receive scheduling navigation (46.9%; P = .02). Of 14 trial participants who received scheduling navigation and cholecystectomy, no participants underwent emergent cholecystectomy compared with 4 of 16 (25.0%) participants in the historical cohort without scheduling navigation (P = .04).
In this pilot randomized clinical trial of socially vulnerable adults with symptomatic cholelithiasis, telemedicine consultation compared with in-person visits did not improve access to elective outpatient surgical care. However, scheduling navigation services may improve access to elective outpatient surgical care. Future large-scale studies are needed to identify possible barriers to virtual health care and mechanisms to address inequities.
ClincialTrials.gov Identifier: NCT05745077.
重要性：有症状性胆石病且社会弱势的患者更有可能面临获得手术治疗的障碍。这种获取障碍可能导致治疗延迟、需要紧急胆囊切除术以及更差的结果。
目的：确定远程医疗与面对面手术咨询对社会弱势群体获得择期胆囊切除术的有效性，并评估在这些人群中预约导航与获得择期胆囊切除术的关联。
设计、地点和参与者：这项在单一学术中心进行的试点随机临床试验纳入了 60 名成人，纳入时间为 2023 年 2 月 1 日至 2024 年 2 月 21 日，对临床结局进行了 3 个月的随访。还回顾性地收集了 2022 年 6 月 30 日至 12 月 29 日转诊的 32 名患者的比较组数据。纳入了具有社会脆弱性的成年人，例如非白种人或非西班牙裔，或没有私人保险或收入较低，伴有症状性胆石病和门诊手术咨询转诊。
干预措施：所有试验参与者均被随机分配至远程医疗或面对面手术咨询组，并接受专业预约导航。后者的干预措施与没有导航协助的历史队列进行了比较。
主要结局和测量：主要结局是完成门诊手术咨询。次要结局包括接受治疗和手术紧迫性。
结果：该试验纳入了 60 名参与者（每组 30 名）。他们的平均（标准差）年龄为 48.2（18.2）岁，50 名（83.3%）为女性，2 名（3.3%）为亚洲人，39 名（65.0%）为黑人，8 名（13.3%）为西班牙裔，11 名（18.3%）为白人，41 名（68.3%）没有私人保险。历史患者队列包括 32 名参与者（平均[标准差]年龄，45.9[3.2]岁；27[84.4%]为女性；3[9.4%]为亚洲人，15[46.9%]为黑人，10[31.3%]为西班牙裔，6[18.8%]为白人；18[56.3%]没有私人保险）。总共有 18 名被分配至远程医疗的试验参与者（60.0%）完成了手术咨询，而 23 名被分配至面对面就诊的试验参与者（76.7%）完成了手术咨询（P = .17）。对于接受胆囊切除术的远程医疗参与者，7 名（42.9%）参与者中 3 名接受了紧急胆囊切除术，而 14 名接受面对面咨询的参与者中没有 1 名（0%）参与者接受了紧急胆囊切除术（P = .03）。在 30 名接受预约导航的试验参与者中，23 名（76.7%）完成了手术咨询，而 32 名未接受预约导航的历史队列患者中，有 15 名（46.9%）完成了手术咨询（P = .02）。在 14 名接受预约导航和胆囊切除术的试验参与者中，没有参与者接受紧急胆囊切除术，而在没有预约导航的历史队列参与者中，有 4 名（25.0%）接受了紧急胆囊切除术（P = .04）。
结论和相关性：在这项针对有症状性胆石病且社会弱势的成年人的试点随机临床试验中，与面对面就诊相比，远程医疗咨询并未改善择期门诊手术治疗的可及性。然而，预约导航服务可能会改善择期门诊手术治疗的可及性。需要进行更大规模的研究来确定虚拟医疗可能存在的障碍和解决不公平问题的机制。
试验注册：ClincialTrials.gov 标识符：NCT05745077。
