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Efficacy of Artificial Intelligence for Gatekeeping in Referrals to Specialized Care

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07019116
Enrollment
934
Registered
2025-06-13
Start date
2025-11-15
Completion date
2029-12-01
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

Primary Care, Primary Care Patients With Chronic Conditions

Brief summary

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.

Interventions

OTHERStandard gatekeeping

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

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.

OTHERSubsequent interactions between primary care and regulation system

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.

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER
Rio Grande do Sul State Health Department - SES/RS
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Referrals with final decision6 monthsThe 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

MeasureTime frameDescription
Time to final decision6 monthsTime to final decision (authorization or deferral) for the referral.
Time to consult in high-risk patients6 monthsTime to specialist appointment for high-priority (red/orange) cases.
Use of remote consultations6 monthsRio Grande do Sul has a provider-to-provider consultation service. The proportion of referrals that used this service will be assessed.
Waitlist size over time6 monthsThe overall size of the referral waitlist will be assessed before and after the implementation of the algorithm.

Countries

Brazil

Contacts

CONTACTDimitris V Rados, Ph.D.
drados@hcpa.edu.br+555133082092
CONTACTNatan Katz, Ph.D.
nkatz@hcpa.edu.br+555133082092
PRINCIPAL_INVESTIGATORDimitris V. Rados, Ph.D.

TelessaúdeRS

Outcome results

None listed

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