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NCT Number: NCT07019116

Efficacy of Artificial Intelligence for Gatekeeping in Referrals to Specialized Care

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central de Regulação Ambulatorial

Porto Alegre, Rio Grande do Sul, Brazil

Location status: Recruiting

Location contact

Natan Katz, MD, PhD

CONTACT

[email protected]

+55513308-2092

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All referrals from a given specialty (waitlist) will be eligible.
  • Specialties will be selected following Rio Grande do Sul Health Department priorities.

Exclusion criteria

  • 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.

Treatment and study plan

Standard gatekeeping

Other

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

AI algorithm

Other

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

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.

Primary outcomes

  1. Referrals with final decision

    Time frame: 6 months

    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.

Secondary outcomes

  1. Time to final decision

    Time frame: 6 months

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

  2. Time to consult in high-risk patients

    Time frame: 6 months

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

  3. Use of remote consultations

    Time frame: 6 months

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

  4. Waitlist size over time

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitris V Rados, Ph.D.

CONTACT

[email protected]

+555133082092

Natan Katz, Ph.D.

CONTACT

[email protected]

+555133082092

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Rio Grande do Sul State Health Department - SES/RS

Registry information

Official study title

Efficacy of an Artificial Intelligence Algorithm for Gatekeeping in Referrals From Primary Care to Specialized Care: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 13, 2025
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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