Actively Recruiting

Phase Not Applicable
All Genders
NCT07019116

Efficacy of Artificial Intelligence for Gatekeeping in Referrals to Specialized Care

Led by Hospital de Clinicas de Porto Alegre · Updated on 2026-02-20

934

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

Sponsors

H

Hospital de Clinicas de Porto Alegre

Lead Sponsor

R

Rio Grande do Sul State Health Department - SES/RS

Collaborating Sponsor

AI-Summary

What this Trial Is About

In Rio Grande do Sul, Brazil, the demand for specialty care referrals has increased sharply with the adoption of the electronic regulatory system, especially in rural areas. In 2023 alone, over 79,000 referrals were submitted monthly, totaling 1.7 million annual gatekeeping decisions. Due to workforce limitations, nearly 70% of referrals are authorized automatically, often without clinical validation. This leads to delays for high-risk patients, unnecessary specialist visits, and a growing backlog, currently over 172,000 pending referrals. To address this, an AI algorithm was developed to triage referrals based on urgency and appropriateness. The investigators propose a prospective controlled study with randomized implementation of the AI tool across selected specialty queues in the electronic referral system. The population will consist of referrals from specialties waitlists from municipalities in Rio Grande do Sul. Specialties to be included will be selected by the State Health Department prospectively according to gatekeeping needs. The intervention will be an AI-based triage algorithm. The control will be a standard gatekeeping process. The primary outcome is the proportion of referrals with a final decision (authorized or redirected to primary care) within six months; secondary outcomes include time to decision and appointment, system-level performance metrics. Referrals will be randomly assigned to algorithmic or human gatekeeping with a 1:1 ratio. The algorithm classifies referrals into two groups: not authorized (pending more data or teleconsultation), authorized. Authorization cases are further divided into routine and high-risk referrals to help the manage demand. Each AI prediction provides a probability from 0 to 1 of authorization (or deferring). The implementation threshold is set at 0.8; cases below this level will be classified as low confidence for decision and will not be included. According to the State Health Department's decisions, several referral lines are expected to be selected for the intervention. A sample size 934 (467 per arm) for each included specialty was calculated to detect a 1.2 relative risk for the primary outcome with 90% power and 5% significance.

CONDITIONS

Official Title

Efficacy of Artificial Intelligence for Gatekeeping in Referrals to Specialized Care

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All referrals from a given specialty waitlist will be eligible.
  • Specialties will be selected according to Rio Grande do Sul Health Department priorities.
Not Eligible

You will not qualify if you...

  • Referrals that the AI algorithm cannot evaluate, including those with attachments like images or PDFs.
  • Referrals that have undergone previous rounds of discussion.
  • Referrals for which the AI algorithm has low confidence in its decision (below 80% probability).

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Central de Regulação Ambulatorial

Porto Alegre, Rio Grande do Sul, Brazil

Actively Recruiting

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Research Team

D

Dimitris V Rados, Ph.D.

CONTACT

N

Natan Katz, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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