NCT07019116 Efficacy of Artificial Intelligence for Gatekeeping in Referrals to Specialized Care
| NCT ID | NCT07019116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Primary Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 934 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 934 participants in total. It began in 2025-11-15 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Dimitris V. Rados, Ph.D.
PRINCIPAL INVESTIGATOR
TelessaúdeRS
Frequently Asked Questions
Who can join the NCT07019116 clinical trial?
This trial is open to participants of all sexes, studying Primary Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07019116 currently recruiting?
Yes, NCT07019116 is actively recruiting participants. Contact the research team at drados@hcpa.edu.br for enrollment information.
Where is the NCT07019116 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT07019116 clinical trial?
NCT07019116 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Dimitris V. Rados, Ph.D. at TelessaúdeRS. The trial plans to enroll 934 participants.