- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401979
The Influence of Explainability and Integrability of AI-CDSS on Usage Behavior Among Primary Care Physicians
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: AI-CDSS with Stepwise Medication and Auto-extraction
- Behavioral: AI-CDSS with Feature Importance and Auto-extraction
- Behavioral: AI-CDSS with Feature Importance and Stepwise Medication
- Behavioral: AI-CDSS with Confidence Display and Auto-extraction
- Behavioral: AI-CDSS with Confidence Display and Stepwise Medication
- Behavioral: AI-CDSS with Confidence Display and Feature Importance
- Behavioral: AI-CDSS with 4 Features (Config 8)
- Behavioral: AI-CDSS with Chain-of-Thought Reasoning and Auto-extraction
- Behavioral: AI-CDSS with Chain-of-Thought Reasoning and Stepwise Medication
- Behavioral: AI-CDSS with Chain-of-Thought Reasoning and Feature Importance
- Behavioral: AI-CDSS with 4 Features (Config 12)
- Behavioral: AI-CDSS with Chain-of-Thought Reasoning and Confidence Display
- Behavioral: AI-CDSS with 4 Features (Config 14)
- Behavioral: AI-CDSS with 4 Features (Config 15)
- Behavioral: AI-CDSS with 4 Features (Config 16)
- Behavioral: AI-CDSS with Sidebar Display and Auto-extraction
- Behavioral: AI-CDSS with Sidebar Display and Stepwise Medication
- Behavioral: AI-CDSS with Sidebar Display and Feature Importance
- Behavioral: AI-CDSS with 4 Features (Config 20)
- Behavioral: AI-CDSS with Sidebar Display and Confidence Display
- Behavioral: AI-CDSS with 4 Features (Config 22)
- Behavioral: AI-CDSS with 4 Features (Config 23)
- Behavioral: AI-CDSS with 4 Features (Config 24)
- Behavioral: AI-CDSS with Sidebar Display and Chain-of-Thought Reasoning
- Behavioral: AI-CDSS with 4 Features (Config 26)
- Behavioral: AI-CDSS with 4 Features (Config 27)
- Behavioral: AI-CDSS with 4 Features (Config 28)
- Behavioral: AI-CDSS with 4 Features (Config 29)
- Behavioral: AI-CDSS with 4 Features (Config 30)
- Behavioral: AI-CDSS with 4 Features (Config 31)
- Behavioral: Full-Featured AI-CDSS
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yushu Liu
- Phone Number: 18772101551
- Email: 386747962@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Tongji Medical College of Huazhong University of Science & Technology School of Medicine and Health Management
-
Contact:
- Yushu Liu
- Phone Number: +86 18772101551
- Email: 386747962@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: AI-CDSS Basic Configuration
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (disabled), Confidence Display (disabled), Feature Importance (disabled), Stepwise Medication (disabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
|
|
Experimental: AI-CDSS Configuration 2
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (disabled), Confidence Display (disabled), Feature Importance (disabled), Stepwise Medication (enabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 3
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (disabled), Confidence Display (disabled), Feature Importance (enabled), Stepwise Medication (disabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 4
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (disabled), Confidence Display (disabled), Feature Importance (enabled), Stepwise Medication (enabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 5
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (disabled), Confidence Display (enabled), Feature Importance (disabled), Stepwise Medication (disabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 6
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (disabled), Confidence Display (enabled), Feature Importance (disabled), Stepwise Medication (enabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 7
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (disabled), Confidence Display (enabled), Feature Importance (enabled), Stepwise Medication (disabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 8
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (disabled), Confidence Display (enabled), Feature Importance (enabled), Stepwise Medication (enabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 9
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (enabled), Confidence Display (disabled), Feature Importance (disabled), Stepwise Medication (disabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 10
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (enabled), Confidence Display (disabled), Feature Importance (disabled), Stepwise Medication (enabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 11
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (enabled), Confidence Display (disabled), Feature Importance (enabled), Stepwise Medication (disabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
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.
|
|
Experimental: AI-CDSS Configuration 12
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (enabled), Confidence Display (disabled), Feature Importance (enabled), Stepwise Medication (enabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Chain-of-Thought Reasoning; Feature Importance; Stepwise Medication; Auto-extraction.
Inactive features: Sidebar Display; Confidence Display.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 13
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (enabled), Confidence Display (enabled), Feature Importance (disabled), Stepwise Medication (disabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Chain-of-Thought Reasoning; Confidence Display.
Inactive features: Sidebar Display; Feature Importance; Stepwise Medication; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 14
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (enabled), Confidence Display (enabled), Feature Importance (disabled), Stepwise Medication (enabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Chain-of-Thought Reasoning; Confidence Display; Stepwise Medication; Auto-extraction.
Inactive features: Sidebar Display; Feature Importance.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 15
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (enabled), Confidence Display (enabled), Feature Importance (enabled), Stepwise Medication (disabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Chain-of-Thought Reasoning; Confidence Display; Feature Importance; Auto-extraction.
Inactive features: Sidebar Display; Stepwise Medication.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 16
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (disabled), Chain-of-Thought Reasoning (enabled), Confidence Display (enabled), Feature Importance (enabled), Stepwise Medication (enabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Chain-of-Thought Reasoning; Confidence Display; Feature Importance; Stepwise Medication.
Inactive features: Sidebar Display; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 17
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (disabled), Confidence Display (disabled), Feature Importance (disabled), Stepwise Medication (disabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Auto-extraction.
Inactive features: Chain-of-Thought Reasoning; Confidence Display; Feature Importance; Stepwise Medication.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 18
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (disabled), Confidence Display (disabled), Feature Importance (disabled), Stepwise Medication (enabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Stepwise Medication.
Inactive features: Chain-of-Thought Reasoning; Confidence Display; Feature Importance; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 19
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (disabled), Confidence Display (disabled), Feature Importance (enabled), Stepwise Medication (disabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Feature Importance.
Inactive features: Chain-of-Thought Reasoning; Confidence Display; Stepwise Medication; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 20
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (disabled), Confidence Display (disabled), Feature Importance (enabled), Stepwise Medication (enabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Feature Importance; Stepwise Medication; Auto-extraction.
Inactive features: Chain-of-Thought Reasoning; Confidence Display.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 21
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (disabled), Confidence Display (enabled), Feature Importance (disabled), Stepwise Medication (disabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Confidence Display.
Inactive features: Chain-of-Thought Reasoning; Feature Importance; Stepwise Medication; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 22
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (disabled), Confidence Display (enabled), Feature Importance (disabled), Stepwise Medication (enabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Confidence Display; Stepwise Medication; Auto-extraction.
Inactive features: Chain-of-Thought Reasoning; Feature Importance.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 23
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (disabled), Confidence Display (enabled), Feature Importance (enabled), Stepwise Medication (disabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Confidence Display; Feature Importance; Auto-extraction.
Inactive features: Chain-of-Thought Reasoning; Stepwise Medication.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 24
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (disabled), Confidence Display (enabled), Feature Importance (enabled), Stepwise Medication (enabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Confidence Display; Feature Importance; Stepwise Medication.
Inactive features: Chain-of-Thought Reasoning; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 25
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (enabled), Confidence Display (disabled), Feature Importance (disabled), Stepwise Medication (disabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Chain-of-Thought Reasoning.
Inactive features: Confidence Display; Feature Importance; Stepwise Medication; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 26
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (enabled), Confidence Display (disabled), Feature Importance (disabled), Stepwise Medication (enabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Chain-of-Thought Reasoning; Stepwise Medication; Auto-extraction.
Inactive features: Confidence Display; Feature Importance.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 27
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (enabled), Confidence Display (disabled), Feature Importance (enabled), Stepwise Medication (disabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Chain-of-Thought Reasoning; Feature Importance; Auto-extraction.
Inactive features: Confidence Display; Stepwise Medication.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 28
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (enabled), Confidence Display (disabled), Feature Importance (enabled), Stepwise Medication (enabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Chain-of-Thought Reasoning; Feature Importance; Stepwise Medication.
Inactive features: Confidence Display; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 29
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (enabled), Confidence Display (enabled), Feature Importance (disabled), Stepwise Medication (disabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Chain-of-Thought Reasoning; Confidence Display; Auto-extraction.
Inactive features: Feature Importance; Stepwise Medication.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 30
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (enabled), Confidence Display (enabled), Feature Importance (disabled), Stepwise Medication (enabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Chain-of-Thought Reasoning; Confidence Display; Stepwise Medication.
Inactive features: Feature Importance; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Configuration 31
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (enabled), Confidence Display (enabled), Feature Importance (enabled), Stepwise Medication (disabled), Auto-extraction (disabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Chain-of-Thought Reasoning; Confidence Display; Feature Importance.
Inactive features: Stepwise Medication; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
|
Experimental: AI-CDSS Full Configuration
Participants interact with an AI Clinical Decision Support System with the following feature settings: Sidebar Display (enabled), Chain-of-Thought Reasoning (enabled), Confidence Display (enabled), Feature Importance (enabled), Stepwise Medication (enabled), Auto-extraction (enabled).
Participants complete 3 clinical case evaluations for respiratory tract infections using this AI configuration.
|
An artificial intelligence-based Clinical Decision Support System for respiratory tract infections.
Active features: Sidebar Display; Chain-of-Thought Reasoning; Confidence Display; Feature Importance; Stepwise Medication; Auto-extraction.
The system provides diagnosis suggestions and antibiotic recommendations for primary care physicians.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correction Event Rate
Time Frame: Immediately after intervention
|
Proportion of cases where the physician's initial decision was incorrect, but was corrected to the right decision after viewing AI recommendations.
Calculated as: (Number of cases where initial decision was wrong AND final decision was correct) / (Total number of cases where initial decision was wrong).
This measures the positive corrective influence of AI-CDSS on physician decision-making.
Continuous variable ranging from 0 to 1.
|
Immediately after intervention
|
|
Misleading Event Rate
Time Frame: Immediately after intervention
|
Proportion of cases where the physician's initial decision was correct, but was changed to an incorrect decision after viewing AI recommendations.
Calculated as: (Number of cases where initial decision was correct AND final decision was wrong) / (Total number of cases where initial decision was correct).
This measures the potential negative influence of AI-CDSS on physician decision-making.
Continuous variable ranging from 0 to 1.
|
Immediately after intervention
|
|
Diagnostic Accuracy (Top-1)
Time Frame: Immediately after intervention
|
Proportion of cases where the physician's final primary diagnosis (first-ranked diagnosis) matches the correct diagnosis (gold standard).
Measured separately for initial diagnosis (before AI) and final diagnosis (after AI) to assess AI impact on diagnostic accuracy.
Continuous variable ranging from 0 to 1.
|
Immediately after intervention
|
|
Diagnostic Accuracy (Top-3)
Time Frame: Immediately after intervention
|
Proportion of cases where the correct diagnosis (gold standard) appears within the physician's top 3 differential diagnoses.
Measured separately for initial diagnosis (before AI) and final diagnosis (after AI).
This captures whether the correct diagnosis was considered even if not ranked first.
Continuous variable ranging from 0 to 1.
|
Immediately after intervention
|
|
Appropriateness of Antibiotic Use Decision
Time Frame: Immediately after intervention
|
Proportion of cases where the physician's final decision on whether to prescribe antibiotics (yes/no) aligns with evidence-based guidelines (gold standard).
This measures the appropriateness of the binary decision to use or withhold antibiotics, regardless of the specific antibiotic chosen.
Measured separately for initial decision (before AI) and final decision (after AI).
Continuous variable ranging from 0 to 1.
|
Immediately after intervention
|
|
Appropriateness of Antibiotic Selection
Time Frame: Immediately after intervention
|
Among cases where antibiotics were prescribed, proportion of cases where the physician's final antibiotic selection (specific drug choice) aligns with evidence-based guidelines (gold standard).
This measures the appropriateness of the specific antibiotic chosen, conditional on the decision to prescribe.
Measured separately for initial selection (before AI) and final selection (after AI).
Continuous variable ranging from 0 to 1.
|
Immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decision Certainty
Time Frame: Immediately after intervention
|
Physician's self-reported confidence level in their final clinical decision after viewing AI recommendations.
Measured using a 5-point Likert scale: 1 = Very Uncertain, 2 = Uncertain, 3 = Neutral, 4 = Certain, 5 = Very Certain.
This reflects the cognitive impact of AI-CDSS on decision confidence.
|
Immediately after intervention
|
|
Intention to Adopt AI-CDSS
Time Frame: Immediately after intervention
|
Measured using a 3-item scale adapted from the Technology Acceptance Model (TAM).
Items assess: (1) willingness to apply AI-CDSS in daily clinical practice when available, (2) intention to use AI-CDSS based on actual patient care needs, and (3) willingness to frequently use AI-CDSS when conditions permit.
Each item is rated on a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree).
Total score ranges from 3 to 15.
|
Immediately after intervention
|
|
Perceived Usefulness of AI-CDSS
Time Frame: Immediately after intervention
|
Measured using a 6-item Perceived Usefulness scale adapted from TAM (Davis, 1989).
Items assess perceived improvements in: (1) task completion speed, (2) job performance, (3) productivity, (4) work effectiveness, (5) ease of work, and (6) overall usefulness.
Each item is rated on a 7-point Likert scale (1=Strongly Disagree to 7=Strongly Agree).
Total score ranges from 6 to 42.
|
Immediately after intervention
|
|
Perceived Ease of Use of AI-CDSS
Time Frame: Immediately after intervention
|
Measured using a 6-item Perceived Ease of Use scale adapted from TAM (Davis, 1989).
Items assess: (1) ease of learning, (2) ease of getting desired functions, (3) clarity of interaction, (4) flexibility of interaction, (5) ease of becoming proficient, and (6) overall ease of use.
Each item is rated on a 7-point Likert scale (1=Strongly Disagree to 7=Strongly Agree).
Total score ranges from 6 to 42.
|
Immediately after intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CXL202601141106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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