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Designing a Large Language Model Architecture for Shared Decision Making and Informed Intentions (DEONCAI3-1)

15 septembre 2026 mis à jour par: Felix G. Rebitschek, Harding Center for Risk Literacy

DEONCAi 3-1: Can Large Language Models Support Shared Decision-Making and Informed Intentions in the Field: An Online Experiment Comparing Them to a Standard Model and to an Evidence-Based Decision Aid

This study investigates a novel, agentic Large Language Model (LLM) architecture designed to facilitate Shared Decision-Making (SDM) in healthcare. While patients increasingly use standard LLMs for health information, these models often struggle with multi-turn conversations and fail to adapt to varying reading levels, disadvantaging vulnerable groups. By utilizing an agentic state-machine, this project aims to overcome common LLM deficits-such as context loss and uncritical agreement-to ensure clinically accurate, participatory patient conversations. The study evaluates whether this architecture improves informed decision-making compared to standard LLMs, particularly for patients with low health literacy.

Aperçu de l'étude

Description détaillée

Background & Current State of Research Shared Decision-Making is widely recognized as the gold standard of patient-centered care. However, its successful implementation in clinical practice is frequently hindered by systemic time and budget constraints. Consequently, patients are increasingly turning to Large Language Models to independently access health information and navigate their medical options.

The Problem: Limitations of Standard LLMs Recent studies indicate that using standard LLMs can digitally reproduce existing health inequalities and participation gaps. These models struggle to adapt to different reading levels without a significant loss in quality. While highly developed prompting techniques can enhance clinical accuracy, the results remain highly variable depending on the specific model and technique used.

A central deficit becomes apparent in multi-turn interactions, which are essential for a natural SDM workflow. In these prolonged conversations, standard LLMs tend to exhibit "context rot," leading to a sharp decline in accuracy as the dialogue progresses. This issue is further exacerbated by model sycophancy (an uncritical tendency to agree with the user) and completion eagerness (a tendency to prematurely conclude the conversation). Because current LLMs often fail to meet evidence-based reporting standards and lack systematic validation of user comprehension, the burden of fact-checking remains entirely on the user. This dynamic significantly disadvantages vulnerable groups, particularly those with lower health literacy.

Project Objectives and Research Questions

This project proposes a technical and clinical solution to these challenges through the following core research questions:

Technical-Conceptual Framework: How can we develop a transparent and replicable workflow that formalizes the SDM process through an agentic state-machine, thereby eliminating structural deficits of LLMs (e.g., context rot and sycophancy) in prolonged interactions?

Clinical Evaluation (Primary Objective): Does this newly developed agentic LLM architecture achieve higher scores in participatory conversation management and demonstrate a significantly greater objective increase in informed decision-making among users during multi-turn interactions, compared to a standard baseline LLM?

Health Equity (Secondary Objective): To what extent can this agentic LLM architecture guarantee effective participatory conversation management for vulnerable patient groups with low health literacy?

Type d'étude

Interventionnel

Inscription (Estimé)

330

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Biological sex: Female.
  • Age: 40 to 70 years old.
  • Country of residence: United States (US) or United Kingdom (UK).
  • Language: Native English speaker (English as first language).
  • Registered and verified user on the academic research platform Prolific.
  • Able to read, understand, and provide informed consent digitally.

Exclusion Criteria:

  • Individuals who do not meet the automated pre-screening criteria on the Prolific platform.
  • Inability to use or access a computer, smartphone, or internet browser required to complete the digital study.

Note: Quotas will be enforced during recruitment to ensure a 50/50 stratified split between participants with and without university entrance qualifications to guarantee variance in educational backgrounds. Once a quota is filled, further participants matching that educational profile will be excluded.

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Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Shared Decision Making Chatbot
Participants will engage in a multi-turn, AI-assisted consultation about mammography screening. They will interact with a newly developed agentic Large Language Model architecture that uses an integrated state-machine designed to actively guide the Shared Decision-Making process, adapt to the user's reading level, and prevent context loss.
An interactive AI chatbot built with an agentic state-machine architecture designed to systematically guide users through the Shared Decision-Making process regarding mammography screening, with built-in ethical guardrails to prevent hallucination and sycophancy.
Comparateur actif: Standard Chatbot
Participants will engage in a conversation about mammography screening using a standard, usual care Large Language Model (Mistral Large). This model represents the current consumer standard for AI health queries and lacks the specialized agentic state-machine and SDM workflow guidance.
An unmodified, standard generative Large Language Model chatbot acting as a baseline control, used by participants to discuss mammography screening.
Comparateur actif: Information brochure
Participants will receive and read the standard informational patient brochure on mammography screening published by the German Institute for Quality and Efficiency in Health Care (IQWiG). This represents the current standard of care for patient information.
The standard digital informational brochure on mammography screening provided by the german Institute for Quality and Efficiency in Health Care (IQWiG), used as a usual care baseline for patient education.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient-Reported Quality of Shared Decision-Making
Délai: Day 1
Assessed using the 9-item Shared Decision Making Questionnaire (SDM-Q-9). This validated instrument measures the patient's perceived involvement in the medical decision-making process. The questionnaire consists of 9 items, each rated on a 6-point scale ranging from 0 ("completely disagree") to 5 ("completely agree"). The raw scores are summed and multiplied by 20/9 to yield a total score ranging from 0 to 100. Higher scores indicate a higher perceived quality and greater patient involvement in shared decision-making.
Day 1

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Multidimensional Informed Decision-Making
Délai: Day 1
Based on Marteau's conceptualization of informed decision-making. An informed decision is achieved when a participant has sufficient objective knowledge about mammography screening and their behavioral intention (to screen or not to screen) is congruent with their personal attitudes toward the screening. This is calculated as a composite measure integrating an objective knowledge test, an attitude assessment, and a screening intention question. Higher objective knowledge scores and higher attitude-intention congruence indicate a better-informed decision.
Day 1
Subjective Decisional Conflict
Délai: Day 1
Assessed using a standardized Decisional Conflict Scale. This measures the participant's perceived uncertainty in choosing a screening option, their clarity of personal values, and their feeling of being supported in decision-making. Scores are transformed to a 0 to 100 scale. Lower scores indicate less decisional conflict and greater decision certainty.
Day 1
Medical Accuracy and Safety of Generated Information
Délai: Day 1
A quantitative and qualitative assessment of the medical accuracy of the AI-generated texts. This is operationalized by counting the frequency (number of occurrences) and categorizing the severity of deviations from established medical evidence (i.e., misinformation or "hallucinations"). These deviations are identified via an integrated ethics module and/or expert review. Lower frequencies and lower severity ratings indicate higher medical accuracy.
Day 1

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Felix G Rebitschek, PhD, Harding Center for Risk Literacy

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 septembre 2026

Achèvement primaire (Estimé)

30 septembre 2026

Achèvement de l'étude (Estimé)

30 septembre 2026

Dates d'inscription aux études

Première soumission

9 septembre 2026

Première soumission répondant aux critères de contrôle qualité

15 septembre 2026

Première publication (Réel)

18 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data (IPD) underlying the results reported in the published article, including survey data (SDM-Q-9, decisional conflict, knowledge scores) and anonymized dialog transcripts, will be shared.

Délai de partage IPD

Data will become available immediately following publication of the primary results and will be accessible indefinitely.

Critères d'accès au partage IPD

Data will be made publicly available as supplement material on the publishers website to any researcher or individual for non-commercial research purposes.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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