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Completed

NCT Number: NCT04972331

Automated AI Voice Calls for Postoperative Follow-up After Arthroscopic Shoulder Instability Surgery

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.

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Key information

Conditions

Shoulder Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICR Clinique Kantys Centre

Nice, 06000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

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

Exclusion:

  • Previous ipsilateral surgery
  • Non-consent

Treatment and study plan

SMS Pre-notification

Other

Participants received an SMS text message approximately 2 hours before the first automated outbound call.

No Pre-notification

Procedure

Participants received no SMS prior to the first automated outbound call.

Primary outcomes

  1. 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

  1. Survey completion within the first attempt window (including inbound callbacks)

    Time frame: 1 week

    Completion during or following the first outbound call, including patient-initiated inbound callbacks.

  2. Call outcome distribution

    Time frame: 1 week

    Classification of call outcomes using a prespecified taxonomy

Sponsors and collaborators

Lead sponsor

Institut de Chirurgie Reparatrice Locomoteur et Sports

Network

Registry information

Official study title

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

Acronym: FOLAI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2021
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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