Generative AI for Medication Counselling and Adherence in Community Pharmacies
9 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
136
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Amman, Giordania
- Petra University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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.
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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
Altri nomi:
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Applicable Counseling Domains Provided Correctly
Lasso di tempo: day 0
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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
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day 0
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Percentage of Essential Counseling Domains Addressed
Lasso di tempo: Day 0
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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.
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Day 0
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Counseling Deficiencies Categorized by Clinical Severity
Lasso di tempo: Day 0
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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).
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Day 0
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Score on the General Medication Adherence Scale (GMAS)
Lasso di tempo: 30 Days Post-Encounter
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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.
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30 Days Post-Encounter
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Number of Participants Achieving Good Adherence
Lasso di tempo: 30 Days Post-Encounter
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The number of participants meeting the validated threshold for "good adherence" based on their GMAS survey responses.
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30 Days Post-Encounter
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Total Score on the Immediate Patient Understanding (Teach-Back) Assessment
Lasso di tempo: Day 0
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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.
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Day 0
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Total Score on the Patient Satisfaction Questionnaire
Lasso di tempo: Day 0
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A questionnaire covering clarity, usefulness, confidence, and overall satisfaction.
Total scores range from 5 to 25, with higher scores indicating greater patient satisfaction.
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Day 0
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Time Spent on Face-to-Face Counseling
Lasso di tempo: Day 0
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Total face-to-face counseling time measured in minutes using audio timestamps from the start of counseling to completion.
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Day 0
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Number of Encounters Based on AI Output Acceptance Level
Lasso di tempo: Day 0
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The proportion of encounters in which the AI-generated counseling output was fully accepted, edited before delivery, or rejected outright by the pharmacist.
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Day 0
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Number of AI-Related Discrepancies Identified
Lasso di tempo: Day 0
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The frequency of detected AI inaccuracies prior to counseling, such as omitted counseling points, overly technical wording, or incomplete missed-dose advice.
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Day 0
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Number of Clinical Near Misses and Safety Incidents
Lasso di tempo: Day 0
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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).
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Day 0
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2026
Completamento primario (Effettivo)
30 marzo 2026
Completamento dello studio (Effettivo)
30 marzo 2026
Date di iscrizione allo studio
Primo inviato
3 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
9 giugno 2026
Primo Inserito (Effettivo)
16 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
16 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Malattie vascolari
- Processi patologici
- Attributi della malattia
- Malattie metaboliche
- Malattie del sistema immunitario
- Malattie delle vie respiratorie
- Malattie polmonari
- Disturbi del metabolismo del glucosio
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità, immediata
- Ipersensibilità
- Disturbi del metabolismo lipidico
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Malattia polmonare, cronica ostruttiva
- Ipertensione
- Asma
- Malattia cardiovascolare
- Diabete mellito
- Dislipidemie
- Malattia cronica
Altri numeri di identificazione dello studio
- Petrauniversity
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .