Augmenting Clinical Workflow With a Structured Chatbot for Patient History Collection and Diagnostic Support

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital

About this trial

Doctors spend much of each visit collecting the patient's medical history, and incomplete histories can delay diagnosis. This study tests an AI chatbot that interviews patients before their appointment and produces a structured summary of their history for the doctor. Adult patients at the first study site, a university gynecology outpatient clinic in Germany, answer the chatbot's questions on a tablet before the doctor visit. The doctor then takes the history and examines the patient as usual, without seeing the chatbot's output. Only after the doctor has finished planning care does the doctor review the chatbot's summary and rate its usefulness and accuracy. The chatbot does not change patient care. Patients also rate the ease of use and acceptability of the chatbot. The investigators will report how useful doctors find the summaries, how complete and correct the summaries are, and how patients experience the tool.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adult women presenting for the first time, or with a new complaint, to the general gynecology outpatient clinic, the gynecology emergency clinic, or as referrals to the gynecology outpatient clinic at the first study site (Leipzig University Hospital, Germany). Patients are recruited consecutively in the clinic waiting area by trained study staff. Additional sites may be added later.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • AI-Based Structured History-Taking Chatbot

    Other intervention

    A large language model-based agentic chatbot that conducts a structured, pre-visit history interview on a study tablet and generates a history summary, differential diagnosis list, and workup suggestions. The output is released to the treating physician only after the physician has completed an independent history, examination, and care plan, and does not influence patient care.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Adult Clinic Patients1 intervention

Trial outcomes

Primary outcomes

1

Proportion of AI history summaries rated useful by the evaluating physician

After completing routine care, the treating physician rates the usefulness of the AI-generated history summary on a 5-point Likert scale (1 = not useful at all, 5 = very useful). The outcome is the proportion of summaries rated 4 or higher, reported with a 95% Wilson confidence interval.

Time frame
Same day as the enrollment visit, after routine care is complete (up to approximately 1 day)

Secondary outcomes

1

Completeness of the AI-generated history

Percentage of items from a standardized history grid that the AI captured correctly, reported overall and by history domain.

Time frame
Same day as the enrollment visit, after routine care is complete (up to approximately 1 day)
2

Correctness of the AI-generated history

Proportion of factually incorrect or missing clinically relevant items in the AI history, per physician review.

Time frame
Same day as the enrollment visit, after routine care is complete (up to approximately 1 day)
3

Plausibility of AI differential diagnoses

Physician rating of plausibility on a 1-5 Likert scale, and concordance of the AI differential with the physician's working diagnosis.

Time frame
Same day as the enrollment visit, after routine care is complete (up to approximately 1 day)
4

Plausibility of AI workup recommendations

Physician rating of the AI's suggested diagnostic workup on a 1-5 Likert scale.

Time frame
Same day as the enrollment visit, after routine care is complete (up to approximately 1 day)

Other outcomes

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

University of Leipzig

Collaborator

This trial is not recruiting at the moment. You can still explore other options: