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New research · Family Medicine
Nature medicine · 1d
AI / informaticsNature medicine · 2026

Generative AI-enabled clinical decision support system in primary care: a pragmatic, cluster-randomized trial.

Ambrose Agweyu, Paul Mwaniki, Vaishnavi Menon … Bilal A Mateen
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Family MedicineAI / informatics

Generative AI assistance did not significantly reduce treatment failure in primary care.

Generative AI-enabled clinical decision support system in primary care: a pragmatic, cluster-randomized trial.

Ambrose Agweyu et al. · Nature medicine · 2026
Background

Rigorous evidence on the performance of large language models (LLMs) in real-world, low-resource clinical settings remains limited.

Methods

Between 22 April and 16 July 2025, 9,691 patients were enrolled, overseen by 103 clinical officers (52 in the LLM-assisted arm and 51 in the control arm).

n = 9,691 patients
Results

AI assistance did not significantly lower the odds of treatment failure

aOR 0.77 (95% CI 0.55 to 1.08)
null 1
0.55
1.08
CI crosses the null - not significant
More results

Here we conducted a pragmatic, cluster-randomized trial in 16 primary care facilities in Kenya.

The primary outcome was an expert-adjudicated composite of treatment failure events experienced within 14 days of enrollment.

The primary outcome did not differ significantly between groups.

More results

In this trial, LLM assistance was safe but did not reduce treatment failure within 14 days and any benefit, if present, is probably modest.

“
Conclusion

Pan-African Clinical Trials Registry: 202502499779176.

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