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Not yet recruiting NCT07401979

The Influence of Explainability and Integrability of AI-CDSS on Usage Behavior Among Primary Care Physicians

No phase Interventional Respiratory Tract Infections (RTI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-CDSS with Stepwise Medication and Auto-extraction, AI-CDSS with Feature Importance and Auto-extraction, AI-CDSS with Feature Importance and Stepwise Medication, AI-CDSS with Confidence Display and Auto-extraction.
Who it may be relevant to
Registry conditions: Respiratory Tract Infections (RTI). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this observational experimental study is to determine how system-level features of artificial intelligence clinical decision support systems (AI-CDSS)-specifically explainability and integrability-affect usage behavior among primary care physicians in China. The study focuses on licensed primary care physicians, regardless of gender, age, years of clinical experience, or prior AI exposure. The main questions it aims to answer are: * Do specific AI features (e.g., feature attribution, chain-of-thought explanation, seamless workflow integration, automated data input) independently influence physicians' adoption intention, diagnostic accuracy, and their perceptions of the system's usefulness and ease of use? * Do pairwise combinations of these AI features produce significant interaction effects-either synergistic or antagonistic-on these outcomes? Researchers will compare 32 distinct AI interface configurations generated from a 2⁶-¹ fractional factorial design (Resolution VI), each representing a unique combination of six binary AI features: (A) gradient-based feature importance (0 = absent, 1 = present), (B) chain-of-thought reasoning (0/1), (C) workflow integration (0 = multiple pop-up alerts, 1 = unified sidebar display), (D) automated data extraction (0 = manual entry, 1 = auto-populated from case text), (E) recommendation scope adapted to primary care settings (0 = restricted to essential options, 1 = full range of recommendations), and (F) model confidence display (0 = absent, 1 = present). This design enables unbiased estimation of all six main effects and all 15 two-way interactions. Participants will: Complete three standardized clinical case scenarios involving common respiratory infections via a web-based simulation platform; First provide an initial diagnosis and treatment plan without any AI input; Then review an AI-generated recommendation embedded with a randomly assigned combination of the six AI features; Revise their final diagnosis and prescription based on the AI suggestion; Rate their adoption intention, perceived usefulness, and perceived ease of use using validated 7-point Likert-scale items after each case.

Interventions

  • Behavioral AI-CDSS with Stepwise Medication and Auto-extraction
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Stepwise Medication; Auto-extraction. Inactive features: Sidebar Display; Chain-of-Thought Reasoning; Confidence Display; Feature Importance. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with Feature Importance and Auto-extraction
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Feature Importance; Auto-extraction. Inactive features: Sidebar Display; Chain-of-Thought Reasoning; Confidence Display; Stepwise Medication. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with Feature Importance and Stepwise Medication
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Feature Importance; Stepwise Medication. Inactive features: Sidebar Display; Chain-of-Thought Reasoning; Confidence Display; Auto-extraction. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with Confidence Display and Auto-extraction
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Confidence Display; Auto-extraction. Inactive features: Sidebar Display; Chain-of-Thought Reasoning; Feature Importance; Stepwise Medication. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with Confidence Display and Stepwise Medication
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Confidence Display; Stepwise Medication. Inactive features: Sidebar Display; Chain-of-Thought Reasoning; Feature Importance; Auto-extraction. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with Confidence Display and Feature Importance
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Confidence Display; Feature Importance. Inactive features: Sidebar Display; Chain-of-Thought Reasoning; Stepwise Medication; Auto-extraction. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with 4 Features (Config 8)
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Confidence Display; Feature Importance; Stepwise Medication; Auto-extraction. Inactive features: Sidebar Display; Chain-of-Thought Reasoning. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with Chain-of-Thought Reasoning and Auto-extraction
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Chain-of-Thought Reasoning; Auto-extraction. Inactive features: Sidebar Display; Confidence Display; Feature Importance; Stepwise Medication. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with Chain-of-Thought Reasoning and Stepwise Medication
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Chain-of-Thought Reasoning; Stepwise Medication. Inactive features: Sidebar Display; Confidence Display; Feature Importance; Auto-extraction. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
  • Behavioral AI-CDSS with Chain-of-Thought Reasoning and Feature Importance
    An artificial intelligence-based Clinical Decision Support System for respiratory tract infections. Active features: Chain-of-Thought Reasoning; Feature Importance. Inactive features: Sidebar Display; Confidence Display; Stepwise Medication; Auto-extraction. The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.

Primary outcome measures

  • Correction Event Rate [Time frame: Immediately after intervention]
  • Misleading Event Rate [Time frame: Immediately after intervention]
  • Diagnostic Accuracy (Top-1) [Time frame: Immediately after intervention]
  • Diagnostic Accuracy (Top-3) [Time frame: Immediately after intervention]
  • Appropriateness of Antibiotic Use Decision [Time frame: Immediately after intervention]
  • Appropriateness of Antibiotic Selection [Time frame: Immediately after intervention]
Secondary outcome measures (4)
  • Decision Certainty [Time frame: Immediately after intervention]
  • Intention to Adopt AI-CDSS [Time frame: Immediately after intervention]
  • Perceived Usefulness of AI-CDSS [Time frame: Immediately after intervention]
  • Perceived Ease of Use of AI-CDSS [Time frame: Immediately after intervention]

Eligibility criteria

Inclusion criteria

  • Be currently employed full-time in clinical practice at a primary care facility, including community health centers, community health stations, township hospitals, or village clinics;
  • Hold a clinical medical license with a specialty in general practice or internal medicine, and have experience in diagnosing and managing respiratory tract infections;
  • Have at least one year of clinical work experience;
  • Be proficient in basic computer use (e.g., web browsing and online questionnaire completion), have reliable internet access, and be capable of independently completing the online experimental tasks;
  • Provide voluntary informed consent to participate in the study.

Exclusion criteria

  • Non-clinical staff (e.g., administrative personnel, pharmacists, laboratory technicians, or public health workers who do not directly provide outpatient clinical care);
  • Individuals unable to independently complete the online experimental procedure or who demonstrate significant difficulty understanding the task instructions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Health services research

Study locations

China · 1 center
  • Tongji Medical College of Huazhong University of Science & Technology School of Medicine a — Wuhan

Identifiers

NCT: NCT07401979 · CXL202601141106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗