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Generative AI for Medication Counselling and Adherence in Community Pharmacies

9 de junio de 2026 actualizado por: Derar H. Abdel-Qader, University of Petra

Human-AI Collaboration in the Pharmacy: A Cluster Randomized Controlled Trial of Generative AI for Medication Counselling and Adherence

Medication counseling within community pharmacies is crucial for managing chronic diseases, yet significant challenges regarding correctness and completeness remain in Jordan. Although generative artificial intelligence (AI) can be utilized for patient education, there is a lack of research on clinical impact and safety of AI in medication counseling conducted by pharmacists in real-world practice. The aim of this study is to evaluate the effect of pharmacist-supervised AI-assisted medication counseling on the correctness and completeness of counseling information and 30-day medication adherence among patients in Jordanian community pharmacies.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Materials and Methods: This pragmatic, two-arm cluster randomized controlled trial enrolled 136 adult patients across 16 community pharmacies in Jordan (8 clusters per arm). Pharmacists in the intervention arm used a standardized prompt strategy with ChatGPT® to generate counseling drafts, which were then verified and edited before delivery. The control arm provided usual counseling. Co-primary outcomes were correctness and completeness of counseling information (percentage scores based on blinded transcript analysis). Secondary outcomes included 30-day medication adherence (General Medication Adherence Scale [GMAS]), immediate patient understanding, and satisfaction. Data were analyzed using mixed-effects linear and logistic regression models.

Tipo de estudio

Intervencionista

Inscripción (Actual)

136

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Jordán
      • Amman, Jordán
        • Petra University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Patient Eligibility Criteria

Inclusion Criteria:

Adults aged 18 years or older. Presenting with a new prescription or a refill for a chronic medication requiring counseling within one of the following classes: antihypertensives, oral antidiabetics, lipid-lowering agents, anticoagulants, or inhaled maintenance therapies.

Willing and able to provide informed consent.

Exclusion Criteria:

Presence of acute infections. Diagnosis of psychiatric disorders or oncological conditions. Presence of severe acute illness requiring urgent medical referral. Cognitive impairment precluding informed consent. Hearing or communication barriers that prevent interview completion without the presence of a caregiver.

Inability to provide a follow-up phone number for the 30-day adherence assessment.

Pharmacy and Pharmacist (Cluster) Eligibility Criteria

Inclusion Criteria:

Pharmacies legally registered in Jordan, providing routine prescription dispensing services, having at least one licensed pharmacist available during recruitment hours, and agreeing to participate for the full trial period.

Licensed pharmacists with a minimum of 2 years of clinical experience, working in participating pharmacies, providing direct patient counseling, and consenting to take part in the study.

Exclusion Criteria:

Pharmacies that are already using structured AI-assisted counseling tools as part of their routine practice.

Pharmacists on temporary placement for less than one month. Pharmacists not involved in patient-facing counseling.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Intervention arm procedures
For all eligible patients in the intervention arm, the pharmacist performed the standard patient assessment and determined which medicine(s) needed counselling. Then, the pharmacist input a prompt in a de-identified format into ChatGPT®. The prompt was a request for an easy-to-understand counselling document with information regarding the indications for the medication, dosage, schedule, route, course, missed doses, possible side effects, important precautions, storage, and advice on taking the medicine as prescribed (Appendix A). The pharmacist ensured that the content generated by the AI was accurate and clear, making corrections where necessary, and then gave verbal counselling to the patient.
Otro: pharmacist-supervised AI-assisted medication counseling

For all eligible patients in the intervention arm, the pharmacist performed the standard patient assessment and determined which medicine(s) needed counselling. Then, the pharmacist input a prompt in a de-identified format into ChatGPT®. The prompt was a request for an easy-to-understand counselling document with information regarding the indications for the medication, dosage, schedule, route, course, missed doses, possible side effects, important precautions, storage, and advice on taking the medicine as prescribed (Appendix A). The pharmacist ensured that the content generated by the AI was accurate and clear, making corrections where necessary, and then gave verbal counselling to the patient.

The AI output was never provided to the patients without pharmacist evaluation. It is worth noting that pharmacists could also reject the AI output as inaccurate, insufficient, hazardous, and inappropriate altogether. Reproducibility was ensured through documenting the date and time, prompt te

Otros nombres:
  • Intervention arm procedures
Sin intervención: Control arm procedures
Pharmacies randomized to the control arm continued to provide usual medication counselling according to their standard routine practice, without access to the AI prompt templates or study AI workflow. Control pharmacists used their usual professional references, as would occur in routine care, but they were not trained in or asked to use ChatGPT® during the trial period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Applicable Counseling Domains Provided Correctly
Periodo de tiempo: day 0
Defined as the proportion of clinically applicable counseling domains communicated accurately during the encounter, compared with a medication-specific reference sheet. Scored on a 0-100 scale, calculated as (Number of applicable domains correctly informed / Total number of applicable domains) x 100.Correctness score= (Number of applicable domains
day 0
Percentage of Essential Counseling Domains Addressed
Periodo de tiempo: Day 0
Defined as the proportion of essential counseling domains that were addressed during the encounter. Scored on a 0-100 scale, calculated as (Number of applicable domains addressed / Total number of applicable domains) x 100.
Day 0

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Counseling Deficiencies Categorized by Clinical Severity
Periodo de tiempo: Day 0
The frequency of omitted or incorrect counseling information, independently assessed by a panel of pharmacists using a 3-point scale: Low Severity (minor wording issues), Moderate Severity (errors leading to sub-therapeutic effects), and High Severity (errors with high potential for significant patient harm).
Day 0
Score on the General Medication Adherence Scale (GMAS)
Periodo de tiempo: 30 Days Post-Encounter
Medication adherence assessed via telephone follow-up using the continuous total score from the General Medication Adherence Scale (GMAS). Higher scores indicate better medication adherence.
30 Days Post-Encounter
Number of Participants Achieving Good Adherence
Periodo de tiempo: 30 Days Post-Encounter
The number of participants meeting the validated threshold for "good adherence" based on their GMAS survey responses.
30 Days Post-Encounter
Total Score on the Immediate Patient Understanding (Teach-Back) Assessment
Periodo de tiempo: Day 0
A brief interviewer-administered understanding assessment based on teach-back principles. Scores range from 0 to 4, with higher scores indicating a better understanding of the medication.
Day 0
Total Score on the Patient Satisfaction Questionnaire
Periodo de tiempo: Day 0
A questionnaire covering clarity, usefulness, confidence, and overall satisfaction. Total scores range from 5 to 25, with higher scores indicating greater patient satisfaction.
Day 0
Time Spent on Face-to-Face Counseling
Periodo de tiempo: Day 0
Total face-to-face counseling time measured in minutes using audio timestamps from the start of counseling to completion.
Day 0
Number of Encounters Based on AI Output Acceptance Level
Periodo de tiempo: Day 0
The proportion of encounters in which the AI-generated counseling output was fully accepted, edited before delivery, or rejected outright by the pharmacist.
Day 0
Number of AI-Related Discrepancies Identified
Periodo de tiempo: Day 0
The frequency of detected AI inaccuracies prior to counseling, such as omitted counseling points, overly technical wording, or incomplete missed-dose advice.
Day 0
Number of Clinical Near Misses and Safety Incidents
Periodo de tiempo: Day 0
The number of encounters featuring a "near miss" (an AI error identified and corrected by the pharmacist before reaching the patient) or an "incident" (inaccurate information that actually reached the patient).
Day 0

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Petra

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • Abdel-Qader, D. H., Al Meslamani, A. Z., Lewis, P. J., & Hamadi, S. (2021). Incidence, nature, severity, and causes of dispensing errors in community pharmacies in Jordan. International journal of clinical pharmacy, 43(1), 165-173. https://doi.org/10.1007/s11096-020-01126-w Abdel-Qader, D. H., et al. (2024). A comprehensive analysis of public satisfaction: Community pharmacists' pandemic preparedness in Jordan. Journal of Applied Pharmaceutical Science, 14(8), 160-168. Abdel-Qader, D. H., et al. (2025). Drug-Drug interaction management among pharmacists in Jordan: A national comparative survey. Pharmacy, 137. https://doi.org/10.3390/pharmacy13050137 Abu Hammour, K., et al. (2023). ChatGPT in pharmacy practice: A cross-sectional exploration of Jordanian pharmacists' perception, practice, and concerns. Journal of Pharmaceutical Policy and Practice, 16(1), 115. Ali, S., Shimels, T., & Bilal, A. I. (2019). Assessment of patient counseling on dispensing of medicines in outpatient pharmacy of Tikur-Anbessa Specialized Hospital, Ethiopia. Ethiopian journal of health sciences, 29(6), 727. Campbell, M. K., et al. (2012). Consort 2010 statement: Extension to cluster randomised trials. BMJ, 345. Chan, A.-W., et al. (2015). SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Revista Panamericana de Salud Pública, 38, 506-514. Elayeh, E. R., et al. (2019). Use of secret simulated patient followed by workshop based education to assess and improve inhaler counseling in community pharmacy in Jordan. Pharmacy Practice (Granada), 17(4). Fattah, F. H., et al. (2025). Comparative analysis of ChatGPT and Gemini (Bard) in medical inquiry: A scoping review. Frontiers in digital health, 7, 1482712. FIP, I. P. F. (2021). Medication review and medicines use review: A toolkit for pharmacists Colophon. FIP, I. P. F. (2025). An artificial intelligence toolkit for pharmacy: An introduction and resource guide for pharmacists. (March). Hammad, E. A., et al. (2022). Feasibi

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2026

Finalización primaria (Actual)

30 de marzo de 2026

Finalización del estudio (Actual)

30 de marzo de 2026

Fechas de registro del estudio

Enviado por primera vez

3 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

16 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Petrauniversity

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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