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Randomized Controlled Trial
. 2024 Oct 1;7(10):e2438137.
doi: 10.1001/jamanetworkopen.2024.38137.

Telemedicine and Access to Elective Cholecystectomy for Socially Vulnerable Adults: A Pilot Randomized Clinical Trial

Affiliations
Randomized Controlled Trial

Telemedicine and Access to Elective Cholecystectomy for Socially Vulnerable Adults: A Pilot Randomized Clinical Trial

Emna Bakillah et al. JAMA Netw Open. .

Abstract

Importance: 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.

Objectives: 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.

Interventions: 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.

Main outcomes and measures: The primary outcome was completion of outpatient surgical consultation. Secondary outcomes included receipt of treatment and operative urgency.

Results: 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).

Conclusions and relevance: 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.

Trial registration: ClincialTrials.gov Identifier: NCT05745077.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Morris reported receiving personal fees from several law firms and from Innocoll Pharmaceuticals outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. CONSORT Flow Diagram

References

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