Efficacy of Artificial Intelligence for Gatekeeping in Referrals to Specialized Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital de Clinicas de Porto Alegre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All referrals from a given specialty (waitlist) will be eligible.

Specialties will be selected following Rio Grande do Sul Health Department priorities.

Disqualifiers

Referrals that the AI algorithm can not evaluate. These include referrals with attachments (further information in image or PDF files) and referrals with previous rounds of discussion.

Referrals in which the algorithm has low confidence in the decision (i.e., informed data lead to a decision with a probability below 80%) will not be included in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard gatekeeping

    Other intervention

    Human evaluators (mostly physicians) review referrals and determine, based on established protocols, whether they should be authorized.

  • AI algorithm

    Other intervention

    An AI algorithm was developed to perform the first evaluation (triaging) of the referrals inserted in the electronic referral system from the Rio Grande do Sul Health Department.

  • Subsequent interactions between primary care and regulation system

    Other intervention

    After the first evaluation of a referral, several subsequent rounds of interaction between gatekeepers and primary care physicians can be conducted to further detail patient needs and urgency.

Treatment groups

934 Participants
are divided into 2 treatment groups
Group A: Standard gatekeeping processActive comparator 2 interventions
Group B: Artificial Intelligence for GatekeepingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Referrals with final decision

The proportion of referrals with a final decision includes those authorized for specialist care and those redirected to primary care without an in-person specialist consultation.

Time frame
6 months

Secondary outcomes

1

Time to final decision

Time to final decision (authorization or deferral) for the referral.

Time frame
6 months
2

Time to consult in high-risk patients

Time to specialist appointment for high-priority (red/orange) cases.

Time frame
6 months
3

Use of remote consultations

Rio Grande do Sul has a provider-to-provider consultation service. The proportion of referrals that used this service will be assessed.

Time frame
6 months
4

Waitlist size over time

The overall size of the referral waitlist will be assessed before and after the implementation of the algorithm.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Clinicas de Porto Alegre

Lead sponsor

Rio Grande do Sul State Health Department - SES/RS

Collaborator