<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260611069750N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the Effect of SMS-Based Feedback on Prescribing Indicators and Related Factors, and Explaining the Barriers and Facilitators Influencing Drug Prescribing Among General Practitioners in the Clinics of Tehran Province</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effect of SMS-Based Feedback on Prescribing Indicators and Related Factors, and Explaining the Barriers and Facilitators Influencing Drug Prescribing Among General Practitioners in the Clinics of Tehran Province</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>645</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91124</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The randomization method in this study is stratified randomization. The unit of randomization is the individual general practitioner, and allocation will be performed in a 1:1 ratio to the intervention and control groups. The randomization strata include the geographic area of practice based on the corresponding university of medical sciences and the physician’s clinic of practice. Within each stratum, the allocation sequence will be generated using statistical software and a computer-based random number generator. The randomization sequence will be prepared by a person independent of the intervention implementation, and the allocation list will be kept confidential until assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irrational drug prescribing with a focus on polypharmacy and antibiotic prescribing in outpatient care.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: **The intervention in this study is SMS-based feedback on prescribing performance among general practitioners. Physicians in the intervention group will receive one feedback text message per month for three consecutive months from the Iran Health Insurance Organization. The content of each message will be prepared based on each physician’s electronic prescribing data from the previous month and will include the mean number of drug items per prescription, the percentage of prescriptions containing antibiotics, comparison with the provincial average and the World Health Organization benchmark of 20% for antibiotic prescribing, and a brief, respectful, non-punitive recommendation to improve rational drug prescribing.****In the first month, corrective feedback will be sent based on baseline prescribing performance. In the second and third months, the content of the message will be determined based on the physician’s prescribing performance in the previous month. If the indicators are higher than the reference values, a corrective comparative message will be sent; if the physician reaches the desirable level, an encouraging message will be sent. The control group will not receive any feedback text messages during the study period.**. Intervention 2: Control group: The control group will not receive any feedback text messages regarding their prescribing performance during the three-month study period. Physicians in this group will continue their usual prescribing practice, and no additional educational, feedback-based, or managerial intervention will be delivered by the research team. Electronic prescribing data for physicians in the control group will be extracted, similar to the intervention group, during the baseline period and throughout the study months to compare changes in prescribing indicators.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
De-identified electronic prescribing data from the Iran Health Insurance Organization and coded qualitative interview files will be available after study completion.
The final study protocol, including objectives, methods, intervention, outcomes, and statistical analysis, will be available for dissemination after finalization.
The statistical analysis plan, including outcomes, variables, statistical models, and primary and secondary analyses, will be available after finalization.
The final clinical study report, including methods, main results, interpretation of findings, and study conclusions, will be available after study completion.

When:
Data will be available after study completion and publication of results, for a limited period, subject to approval by the research team and the relevant organization.
The protocol will be made available after final study registration and required approvals.
The statistical analysis plan will be available after protocol finalization and before the final data analysis.
The clinical study report will be available after completion of the study and finalization of the results.

To whom:
Qualified researchers for scientific purposes may access the data upon formal request and approval by the research team and the Iran Health Insurance Organization.
Researchers, reviewers, and individuals with scientific or academic purposes may access the protocol upon approval by the principal investigator.
Researchers, reviewers, and individuals with scientific purposes may access the statistical analysis plan upon approval by the principal investigator.
Researchers, reviewers, and individuals with scientific or academic purposes may access the clinical study report upon approval by the principal investigator.

Conditions:
The data may be used only for scientific and research purposes, in de-identified form, after approval of the request and compliance with confidentiality requirements.
The protocol may be used only for scientific, research, and academic dissemination purposes with proper citation of the source.
This document may be used only for scientific, research, and methodological review purposes with proper citation of the source.
The clinical study report may be used only for scientific, research, and educational purposes with proper citation of the source.

Where to obtain:
Applicants should submit their request to the principal investigator and, if required, to the Tehran Provincial Office of the Iran Health Insurance Organization.
Applicants should contact the principal investigator to request access.
Applicants should contact the principal investigator to request access.
Applicants should contact the principal investigator to request access.

How to obtain:
After formal submission, the request will be reviewed for scientific purpose, confidentiality compliance, and approval by the principal investigator and the relevant organization; if approved, limited access will be granted.
After submission, the request will be reviewed by the principal investigator, and if approved, the protocol will be provided.
After review by the principal investigator, and if approved, the statistical analysis plan will be provided.
After review by the principal investigator, and if approved, the clinical study report will be provided.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nezam Armand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enqelab Street, Qods Street, Pour Sina Street, School of Public Health</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 2816 5607</telephone>
        <email>armandnezam@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nezam Armand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>**Enqelab Street, Qods Street, Pour Sina Street, School of Public Health**</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 2816 5607</telephone>
        <email>armandnezam@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The physician must be registered as a “general practitioner” in the Iran Health Insurance Organization electronic prescribing system.
The physician must be working in clinics affiliated with the Iran Health Insurance Organization.
The physician’s workplace must be located in one of the catchment areas of Tehran, Iran, or Shahid Beheshti Universities of Medical Sciences.
The physician must have at least 30 recorded drug prescriptions during the baseline period.
The physician must have at least one recorded prescription during the study year.
The physician’s prescribing data must be retrievable and attributable to the physician in the system.
A valid mobile phone number must be available for receiving feedback text messages.</inclusion_criteria>
      <agemin>26 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The physician is simultaneously participating in another similar prescribing feedback program or intervention.
No valid, usable mobile phone number is available to receive feedback text messages.
The physician’s identifying or prescribing data are incomplete or inconsistent in a way that affects allocation or analysis.
Prescriptions cannot be reliably attributed to the physician or to the clinic of practice.
The physician has left the clinic setting before randomization.
The physician is on prolonged leave, assignment, or absence during the study period in a way that affects prescribing activity.
The physician has unreliable or outlier records caused by major system or registration errors.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: **The intervention in this study is SMS-based feedback on prescribing performance among general practitioners. Physicians in the intervention group will receive one feedback text message per month for three consecutive months from the Iran Health Insurance Organization. The content of each message will be prepared based on each physician’s electronic prescribing data from the previous month and will include the mean number of drug items per prescription, the percentage of prescriptions containing antibiotics, comparison with the provincial average and the World Health Organization benchmark of 20% for antibiotic prescribing, and a brief, respectful, non-punitive recommendation to improve rational drug prescribing.****In the first month, corrective feedback will be sent based on baseline prescribing performance. In the second and third months, the content of the message will be determined based on the physician’s prescribing performance in the previous month. If the indicators are higher than the reference values, a corrective comparative message will be sent; if the physician reaches the desirable level, an encouraging message will be sent. The control group will not receive any feedback text messages during the study period.**</i_keyword>
      <i_keyword>Control group: The control group will not receive any feedback text messages regarding their prescribing performance during the three-month study period. Physicians in this group will continue their usual prescribing practice, and no additional educational, feedback-based, or managerial intervention will be delivered by the research team. Electronic prescribing data for physicians in the control group will be extracted, similar to the intervention group, during the baseline period and throughout the study months to compare changes in prescribing indicators.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean number of drug items per prescription. Timepoint: second half of the year before the intervention, and the post-intervention period in Azar, Dey, and Bahman. Method of measurement: These variables are measured at the physician level using data recorded in the Iran Health Insurance Organization electronic prescribing system. The mean number of drug items is calculated by dividing the total number of prescribed drug items by the total number of prescriptions.</prim_outcome>
      <prim_outcome>Percentage of prescriptions containing antibiotics. Timepoint: second half of the year before the intervention, and the post-intervention period in Azar, Dey, and Bahman. Method of measurement: These variables are measured at the physician level using data recorded in the Iran Health Insurance Organization electronic prescribing system. The percentage of prescriptions containing antibiotics is calculated by dividing the number of prescriptions containing at least one antibiotic by the total number of prescriptions and multiplying by 100.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-10</approval_date>
        <contact_name>School of public health and allied medical sciences Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Public Health, Tehran University of Medical Sciences, Enqelab Square, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
