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The goal of this clinical trial is to learn how the use of a large language model (LLM) based tool affects outpatient clinical care in adult patients attending general hospital outpatient clinics. The main questions it aims to answer are:
Does the use of an LLM-based tool affect the efficiency of outpatient visits? Does the use of an LLM-based tool affect the experience of doctors and patients during outpatient care?
Researchers will compare outpatient visits supported by an LLM-based tool to standard outpatient visits without such a tool, to see whether and how the tool influences the care process and the experiences of doctors and patients.
Participants will:
Take part in outpatient visits that may or may not involve an LLM-based tool, depending on their assigned group Complete a short questionnaire about their visit experience after the consultation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Outpatient Care (No AI) | No Intervention | Neither doctors nor patients use a large language model based tool. Outpatient consultations and documentation are conducted following routine clinical practice. | |
| Outpatient Care With a Large Language Model Tool | Experimental | Before the consultation, patients complete an AI-based pre-consultation interaction. During the visit, a large language model based tool is available to support the outpatient consultation process. Doctors may refer to the tool during the visit. |
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| Outpatient Care With a Large Language Model Tool and Workflow Support | Experimental | Before the consultation, patients complete an AI-based pre-consultation interaction. During the visit, a large language model based tool is used together with additional workflow support to integrate the tool's output into the outpatient consultation process. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Large Language Model Based Tool | Other | A large language model based tool is introduced into the outpatient consultation workflow to support the consultation and documentation process. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the Outpatient Consultation | Time of the outpatient consultation, measured in milliseconds | During the outpatient visit |
| Doctor-Reported Efficiency of the Consultation | Doctor's self-rated efficiency of the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high), with higher scores indicating higher perceived efficiency. | Immediately after the consultation |
| Doctor-Reported Satisfaction With the Consultation Process | Doctor's satisfaction with the consultation process, measured on a 5-point Likert scale (1 = very low to 5 = very high), with higher scores indicating higher satisfaction. | Immediately after the consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Doctor-Reported Efficiency of Obtaining Patient Information | Doctor's self-rated efficiency in obtaining the patient's clinical information (such as symptoms, history, prior examinations) during the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate higher efficiency. | Immediately after the consultation |
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Inclusion Criteria:
Doctors:
Patients:
Exclusion Criteria:
Patients:
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This is a cluster-randomized crossover trial in which the unit of randomization is the doctor-session (i.e., an individual outpatient doctor on a given clinic day). Each participating doctor is assigned, in randomized order, to each of the three study conditions across multiple clinic sessions, so that every doctor contributes sessions to all three groups (crossover at the doctor level).
Patients are nested within doctor-sessions. Each patient is allocated to a single study group, determined by the group assignment of the doctor-session in which their visit occurs, and therefore receives only one condition (no crossover at the patient level). At the time of registering for a clinic appointment, patients are not aware of which group their chosen doctor's session has been assigned to; this becomes known only after registration.
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| Workflow Support for Large Language Model Tool Integration | Other | Additional workflow support is provided to integrate the output of the large language model based tool into the consultation process, approximating a more integrated deployment of the tool. |
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| Doctor-Reported Cognitive Effort in Clinical Decision-Making | Doctor's self-rated cognitive effort invested in clinical decision-making during the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater effort. | Immediately after the consultation |
| Doctor-Reported Burden of Clinical Documentation | Doctor's self-rated burden of completing the outpatient medical record for the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater burden. | Immediately after the consultation |
| Doctor's Intention to Continue Using the Tool | Doctor's intention to continue using the large language model based tool in routine practice, measured on a 5-point Likert scale (1 = strongly unwilling to 5 = strongly willing); higher scores indicate stronger intention. | Within 1 week after the participating doctor completes all enrolled consultations |
| Patient Trust in the Physician | Patient's level of trust in the physician after the visit, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater trust. | Immediately after the consultation |
| Patient Satisfaction With the Visit | Patient's satisfaction with the visit, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater satisfaction. | Immediately after the consultation |
| Patient-Perceived Physician Attentiveness | Patient-perceived attentiveness of the physician during the visit, assessed by a multi-item measure and reported as a composite score on a 1-5 scale; higher scores indicate greater perceived attentiveness. | Immediately after the consultation |
| Patient Satisfaction With the AI Pre-Consultation (Arm 2 and Arm 3 ) | Patient's satisfaction with the AI-based pre-consultation interaction, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater satisfaction. Assessed only in Arm 2 and Arm 3. | Immediately after the consultation |
| Patient's Intention to Use AI Pre-Consultation in the Future (Arm 2 and Arm 3) | Patient's intention to use AI-based pre-consultation again in the future, measured on a 5-point Likert scale (1 = strongly unwilling to 5 = strongly willing); higher scores indicate stronger intention. Assessed only in Arm 2 and Arm 3. | Immediately after the consultation |