- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07743320
Evaluating the Effectiveness of an AI-Powered Physician Assistant in Improving Patients' and Physicians' Satisfaction in Anaesthesiology Clinics
Evaluating the Effectiveness of an AI-Powered Physician Assistant in Improving Patients' and Physicians' Satisfaction in Anaesthesiology Clinics of a Tertiary Care Hospital
This trial aimed to evaluate the effectiveness of an AI-Powered Physician Assistant in improving patients' satisfaction with the quality of care. It also aims to evaluate physicians' satisfaction with the integration of a Physician Assistant into their clinical workflows. The primary research question is
A. What is the effect of an AI-powered Physician Assistant on patients' satisfaction with their quality of care compared to the standard care?
The secondary questions are as follows:
B1. How satisfied are physicians with integrating an AI-powered physician assistant into their daily clinical workflows?
B2. Which factors are significantly associated with patient satisfaction regarding the AI-Powered Physician Assistant?
B3. Is there a statistically significant difference in mean consultation time per patient between those receiving AI-assisted care and those receiving only standard of careonly ?
Participants will be enrolled from pre-operative outpatient clinics, including patients attending clinic for anaesthetic clearance prior to surgery and consultant anaesthetists providing care.
Patients will serve as the unit of randomization and will be assigned to one of two study arms on each clinic day. On each clinic day, the first 8 eligible patients presenting for consultation will be randomly assigned to the intervention group or the control group in a 1:1 ratio. Intervention patients will proceed to a dedicated waiting room for structured digital intake via an AI platform (demographics, symptoms, history, clinical data) and receive AI-assisted care. Control group patients will undergo routine standard care protocols. The consultant physician will evaluate both arms during each clinic session, reviewing physician assistant-generated patient summaries and charts for patients in both the intervention and control groups.
Each patient will be asked to fill out the survey at the end of the consultation with the physician. The consultants will be requested to fill out a survey at the end of the day.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dileep Kumar
- Número de teléfono: +923332168948
- Correo electrónico: dileep.kumar@aku.edu
Copia de seguridad de contactos de estudio
- Nombre: Shifa Habib
- Correo electrónico: shifa.habib@aku.edu
Ubicaciones de estudio
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Sindh
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Karachi, Sindh, Pakistán, 74800
- Aga Khan University Hospital
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Contacto:
- Dileep Kumar
- Número de teléfono: +923332168948
- Correo electrónico: dileep.kumar@aku.edu
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Contacto:
- Shifa Habib
- Correo electrónico: shifa.habib@aku.edu
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Investigador principal:
- Dileep Kumar
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Patients and Patients' Proxies
Inclusion Criteria:
- Consent to participate
- Age 18 years and above
- Initial patients
- Possession of a phone
- Read and write Urdu and/or English
Exclusion Criteria:
- Emergency Care patients
- Follow-up patients
Physicians:
Inclusion Criteria
- Attending or Consultant Physician
- Consent to participate
- Workflow integrated with AI Assistant
Exclusion Criteria
- Residents and Senior Medical Officers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AI-Assisted Care
The patients in this arm will receive AI-assisted care in addition to the standard care.
The AI platform will take the patient's history, and then the patient will talk to the consultant as part of the routine flow.
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The study participant allocated to the intervention arm will interact with the AI-physician assistant application before they consult with the physician.
The application will collect medical history of the patient.
This will then be followed by an AI-generated clinical summary, which their physicians will receive before the consultation begins.
Physicians will review this summary and ask further questions of patients if required.
Any additions and changes in the patient's history will also be made.
Physicians will subsequently conduct a physical examination of the patient.
After this, the physician will be able to view AI- and guideline-based suggestions for the patient's assessment and pre-operative management.
The recommendations can be selected, modified, or not used as per the physician's expertise.
All additions within the application can be either typed manually or verbalised via an AI-assisted scribe within the application.
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Sin intervención: Standard Care
The patients in this arm will receive standard care.
The standard of care for our study is what is usually applied in Anaesthesiology outpatient clinics, with consultants seeing the patients after the resident.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Satisfaction and Outpatient Experience Score (Adapted NHS Outpatient Survey - Patient Questionnaire)
Periodo de tiempo: From enrollment to the end of the study, for each patient, for 8 weeks
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Patient satisfaction will be evaluated across two domains: (1) effective utilization of waiting time and (2) receipt of patient-centered care during the outpatient visit. Evaluated post-consultation using a structured survey adapted from the NHS Outpatient Survey: Section A (Wait Time): Wait duration (A1) and wait time utility (A2). Section B (Doctor Interaction): Patient-centered care, consultation duration, listening, and clarity (B2-B7). Section C (AI Assistant - Intervention Arm Only): Perceived listening, trust, and privacy (C1-C6). Section D (Overall Impression): Respect, dignity, and care- quality (D1-D3). Ordinal items are assigned numerical scores to calculate a composite mean score and domain sub-scores (range: 1.0-5.0). Higher scores indicate greater satisfaction. |
From enrollment to the end of the study, for each patient, for 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Daily Physician Satisfaction and Workflow Efficiency Score (End-of-Day Physician Survey)
Periodo de tiempo: From enrollment to the end of the study, for each physician, for 8 weeks
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Physician satisfaction and workflow efficiency will be evaluated using an end-of-day survey administered to physicians whose patients were recruited into the study. Evaluated using a two-part structured questionnaire: Section 1 (Comparative Workflow): Binary comparisons across 5 domains (consultation duration, patient engagement, documentation efficiency, cognitive workload, and focus on patient care), with 3-point follow-up sub-questions for favorable intervention responses. Section 2 (Intervention Utility): 6 intervention-specific items assessing accuracy/trust, workflow efficiency, workload relief, and overall satisfaction (5-point ordinal scales; 1 = Strongly Disagree, 5 = Strongly Agree). Daily composite mean scores are calculated from Sections 1 and 2 (range: 1.0-5.0). Higher scores indicate greater satisfaction. |
From enrollment to the end of the study, for each physician, for 8 weeks
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Total Physician Consultation Duration (Stopwatch Timestamps)
Periodo de tiempo: From enrollment to the end of the study, for each patient, for 8 weeks
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Evaluates total physician consultation duration (in minutes) for each patient during their outpatient clinic encounter. Consultation time refers to the active time spent by the physician while the patient is inside the consultation room. It encompasses the time taken to inquire about symptoms, conduct physical examinations, prescribe treatments, and provide counseling. Duration is objectively measured in minutes using manual stopwatch timestamps, initiated the moment the patient enters the consultation room and concluded when the patient departs. Mean total consultation times will be calculated per patient and compared between the intervention and standard care arms. Lower or more optimized consultation durations reflect enhanced workflow efficiency. |
From enrollment to the end of the study, for each patient, for 8 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Process flow evaluation outcome - Mean Queuing Time (Timestamp Tracking)
Periodo de tiempo: From enrollment to the end of the study, for each patient, for 8 weeks
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Recorded using objective timestamps across two sequential intervals: Interval 1: Completion of counter registration to initiation of vital signs measurement. Interval 2: Completion of vital signs measurement to patient entry into the physician consultation room. Intervals are combined into a single aggregated total queuing time per patient visit. Lower mean queuing times indicate improved operational workflow efficiency. |
From enrollment to the end of the study, for each patient, for 8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dileep Kumar, Aga Khan University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-12272-41803
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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