Generative AI for Medication Counselling and Adherence in Community Pharmacies

June 9, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan
        • Petra University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Other: 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

Other Names:
  • Intervention arm procedures
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Applicable Counseling Domains Provided Correctly
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Counseling Deficiencies Categorized by Clinical Severity
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Petra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Petrauniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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