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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04972331

Acronym

FOLAI

Enrollment

310

Registered

2021-07-22

Start date

2026-01-27

Completion date

2026-02-13

Last updated

2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Instability

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.

Interventions

OTHERSMS Pre-notification

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

PROCEDURENo Pre-notification

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Survey completion during the first automated outbound call	1 week	Proportion of participants who completed the automated survey during the first outbound call attempt.

Secondary

Measure	Time frame	Description
Survey completion within the first attempt window (including inbound callbacks)	1 week	Completion during or following the first outbound call, including patient-initiated inbound callbacks.
Call outcome distribution	1 week	Classification of call outcomes using a prespecified taxonomy

Countries

France

Contacts

STUDY_CHAIRChristophe Trojani, MD,PhD

ICR-Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026