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Clinical Trials/NCT04972331
NCT04972331
Completed
Not Applicable

Automated AI Voice Calls for Postoperative Orthopedic Follow-up: A Randomized Trial of SMS Pre-notification and Blinded Validation of PROM Capture.

Institut de Chirurgie Reparatrice Locomoteur et Sports1 site in 1 country310 target enrollmentJanuary 27, 2026

Overview

Phase
Not Applicable
Intervention
SMS Pre-notification
Conditions
Not specified
Sponsor
Institut de Chirurgie Reparatrice Locomoteur et Sports
Enrollment
310
Locations
1
Primary Endpoint
Survey completion during the first automated outbound call
Status
Completed
Last Updated
2 months ago

Overview

Brief Summary

This prospective, single-center randomized clinical trial evaluates the technical efficacy, accuracy, and operational performance of an automated conversational artificial intelligence (AI) voice agent for postoperative follow-up after arthroscopic shoulder instability surgery. The study examines whether SMS pre-notification improves survey completion during the first automated outbound call and assesses the accuracy of AI-captured patient-reported outcomes compared with blinded human review.

Detailed Description

Participants who underwent arthroscopic shoulder instability surgery at least one year prior were contacted using an automated AI voice agent to collect standardized postoperative outcomes. Patients were randomized 1:1 to receive an SMS pre-notification prior to the first automated call or no pre-notification. The AI agent conducted structured interviews and classified call outcomes using a prespecified taxonomy. A hybrid protocol combining automated outbound calls, inbound callbacks, and targeted human follow-up was implemented to maximize data capture while minimizing resource use. All completed calls were independently audited by a blinded human reviewer to assess agreement with AI-extracted outcomes.

Registry
clinicaltrials.gov
Start Date
January 27, 2026
End Date
February 13, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut de Chirurgie Reparatrice Locomoteur et Sports
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years
  • History of arthroscopic shoulder instability surgery
  • Minimum postoperative follow-up of 12 months
  • Valid telephone contact information

Exclusion Criteria

  • Previous ipsilateral surgery
  • Non-consent

Arms & Interventions

CONTROL

No Pre-notification

Intervention: SMS Pre-notification

INTERVENTION

SMS Pre-notification

Intervention: No Pre-notification

Outcomes

Primary Outcomes

Survey completion during the first automated outbound call

Time Frame: 1 week

Proportion of participants who completed the automated survey during the first outbound call attempt.

Secondary Outcomes

  • Survey completion within the first attempt window (including inbound callbacks)(1 week)
  • Call outcome distribution(1 week)

Study Sites (1)

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