Automated AI Voice Calls for Postoperative Orthopedic Follow-up: A Randomized Trial of SMS Pre-notification and Blinded Validation of PROM Capture.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 310
- Locations
- 1
- Primary Endpoint
- Survey completion during the first automated outbound call
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Other)
INTERVENTION
SMS Pre-notification
Intervention: No Pre-notification (Procedure)
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)