<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04417400</url>
  </required_header>
  <id_info>
    <org_study_id>MZ 0120-321/2016-2</org_study_id>
    <secondary_id>P1-0189</secondary_id>
    <nct_id>NCT04417400</nct_id>
  </id_info>
  <brief_title>Evaluation of Medicines Use Review in Slovenia</brief_title>
  <acronym>SLOPUZ</acronym>
  <official_title>Benefits of Medicines Use Review Service in Slovenia: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitja Kos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Comunity pharmacy Celjske lekarne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Gorenjske lekarne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Goriška lekarna Nova Gorica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Javni zdravstveni zavod Mariborske lekarne Maribor</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Kraške lekarne Ilirska Bistrica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Lekarna Brežice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Lekarna Kočevje</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Lekarna Ljubljana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Lekarna Ormož</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Lekarna Sevnica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Lekarne Ptuj</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Obalne lekarne Koper</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Pomurske lekarne Murska Sobota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Comunity pharmacy Žalske lekarne Žalec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ljubljana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medicines Use Review service (PUZ) has been officially introduced in Slovenian pharmacy&#xD;
      practice in 2015 and has been offered to pharmacy customers by pharmacist, certified to&#xD;
      provide the service. Patients can to talk to a pharmacist and discuss their medicines, how&#xD;
      they use it and any issues or question they might have. We designed a study to evaluate how&#xD;
      Medicines Use Review (PUZ) work and how it is reaching the set objectives. The objectives of&#xD;
      the PUZ service are to address actual patient medicines use and consequently improve&#xD;
      medication adherence, identify and solve drug related problems and enhance medication&#xD;
      knowledge. Pharmacists, who are certified to provide the service, recognized the patients,&#xD;
      who might need the service and invited them to participate in the study. The study consisted&#xD;
      of two visits in 12 weeks' time period. Patients, who decided to participate, were randomly&#xD;
      allocated in two groups - intervention and control. Both groups were interviewed and&#xD;
      fulfilled questionnaires at visit 1 (V1). Afterwards the test group patients received PUZ.&#xD;
      After 12 weeks both groups attended the visit 2 (V2), where they were re-interviewed and&#xD;
      fulfilled questionnaires again. After the study completion also the patients from control&#xD;
      group received PUZ due to ethical reasons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2017</start_date>
  <completion_date type="Actual">September 16, 2017</completion_date>
  <primary_completion_date type="Actual">September 16, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Upon enrollment patients were centrally randomized into two groups -test and control. Patients from the test group received MUR at visit 1. After 12 weeks both groups were reinterviewed. Upon study completion, patients from the control group received MUR due to ethical reasons, however the documentation was not part of the study anymore.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Patients and pharmacist were blind to the intervention at the time of enrollment.&#xD;
Afterwards, pharmacist were notified about the randomization to be able to prepare for the patients that will receive MUR at the visit 1. Patients were blinded until the visit 1 - until after the baseline data collection&quot;</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>medication adherence</measure>
    <time_frame>12 weeks (V2-V1)</time_frame>
    <description>Self-reported medication adherence to multiple medications, evaluated by an 8-item Morisky Medication Adherence Scale (©MMAS-8) and scored with ©Morisky Widget MMAS-8 Software. MUR impact was defined as the relative difference in in MMAS-8 score after 12 weeks (V2-V1) between test and control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>drug-related problems</measure>
    <time_frame>12 weeks (V2-V1)</time_frame>
    <description>The changes in the proportion of manifested DRPs, the proportion of patients with at least one mDRPs, and the risk of the mDRPs between visits. This outcome only considered for the intervention group (test group), therefore the before-after analysis was applied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medicine-associated burden</measure>
    <time_frame>12 weeks (V1-V2)</time_frame>
    <description>MUR impact on medicine-associated burden was defined as the mean relative difference in the score of Living with Medicines Questionnaire (©LMQ), visual analog scale (VAS) and each domain score between test and control group after 12 weeks (V1-V2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient information ('knowledge') regarding medicines</measure>
    <time_frame>12 weeks</time_frame>
    <description>Interview with the patients. Patients answered three questions regarding each of their regularly used prescription medicines: (i) &quot;What are you taking the medicine for?&quot;, to state the purpose of medicine use; (ii) &quot;How are you supposed to take the medicine?&quot;, to state the daily dose; and (iii) &quot;Do you know of any special warnings regarding the medicine? If yes, which ones?&quot;. Accuracy of answers regarding the purpose of medicine and its daily dose were checked by comparing them with either physician instructions or, when physician instructions were unavailable, Summary of Product Characteristics (SmPC). Answers were deemed to be 'correct' if they matched the information in these sources, 'incorrect' if they did not match or 'not known' if patients responded with &quot;I don't know&quot; or 'no'. Proportions of correct and incorrect answers per patient-medicine, and proportions of improvement or deterioration in given information between visits for the test and control group, were assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Medicines Use Review Service</condition>
  <condition>Multiple Medication</condition>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who received MUR at visit 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients received standard care and MUR after visit 2 (upon completion of the study)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>medicines use review</intervention_name>
    <description>The provision of MUR service as defined in the SOP MUR (Slovene Chamber of Pharmacies). It is classified as a type 2a review (PCNE typology) and it is intended for the patients to support them in regular and proper medicines use. MUR is performed based on medication history and information provided by the patient in a purposely scheduled conversation with the pharmacist. Pharmacists must be certified to provide MUR. MUR goal is to identify DRPs and recommend interventions to resolve them. During the MUR interview, the pharmacist completes a working sheet that records information regarding medicines, identified DRPs and recommended interventions. After the MUR interview, patients are provided with a personal medicines card that contains all the information that is needed to support effective and safe medicines use (dosing regimen, taking with/without food, special warnings, recommendations, etc.).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least one prescription medicine for a chronic condition for at least six months&#xD;
&#xD;
          -  deemed to be suitable for MUR by a pharmacist, certified to provide the MUR service;&#xD;
&#xD;
          -  ability to communicate in Slovenian; The inclusion of patients was performed in&#xD;
             accordance with the SOP MUR, to reflect how patients are generally offered MUR service&#xD;
             in Slovenia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  urgent need of MUR (the service delay due to randomization would risk their health);&#xD;
&#xD;
          -  referred for MUR by a healthcare professional (general practitioner, nurse, etc.);&#xD;
&#xD;
          -  the patient's carer, rather than the patient themselves, was able to attend the&#xD;
             interviews and receive MUR;&#xD;
&#xD;
          -  previously received MUR or an advanced medication review;&#xD;
&#xD;
          -  difficulties understanding, communicating or other issues (vision, hearing) that might&#xD;
             affect study outcomes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor Locatelli, M.Pharm, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Ljubljana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mitja Kos, MPharm, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ljubljana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Urska Nabergoj Makovec, MPharm</last_name>
    <role>Study Chair</role>
    <affiliation>University of Ljubljana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community pharmacy &quot;Lekarna Brežice&quot;</name>
      <address>
        <city>Brežice</city>
        <zip>8250</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Celjske lekarne javni zavod&quot;</name>
      <address>
        <city>Celje</city>
        <zip>3000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Kraške lekarne Ilirska Bistrica&quot;</name>
      <address>
        <city>Ilirska Bistrica</city>
        <zip>6250</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Obalne lekarne Koper&quot;</name>
      <address>
        <city>Koper</city>
        <zip>6000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Lekarna Kočevje&quot;</name>
      <address>
        <city>Kočevje</city>
        <zip>1330</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot; Gorenjske lekarne&quot;</name>
      <address>
        <city>Kranj</city>
        <zip>4000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Lekarna Ljubljana&quot;</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Javni zdravstveni zavod Mariborske lekarne Maribor&quot;</name>
      <address>
        <city>Maribor</city>
        <zip>2000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Pomurske lekarne Murska Sobota&quot;</name>
      <address>
        <city>Murska Sobota</city>
        <zip>9000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Goriška lekarna Nova Gorica&quot;</name>
      <address>
        <city>Nova Gorica</city>
        <zip>5000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Lekarna Ormož&quot;</name>
      <address>
        <city>Ormož</city>
        <zip>2270</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Lekarne Ptuj&quot;</name>
      <address>
        <city>Ptuj</city>
        <zip>2250</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Lekarna Sevnica&quot;</name>
      <address>
        <city>Sevnica</city>
        <zip>8290</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community pharmacy &quot;Žalske lekarne Žalec&quot;</name>
      <address>
        <city>Žalec</city>
        <zip>3310</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <reference>
    <citation>Nabergoj Makovec U, Kos M, Pisk N. Community pharmacists' perspectives on implementation of Medicines Use Review in Slovenia. Int J Clin Pharm. 2018 Oct;40(5):1180-1188. doi: 10.1007/s11096-018-0644-6. Epub 2018 Jun 16.</citation>
    <PMID>29909563</PMID>
  </reference>
  <reference>
    <citation>Griese-Mammen N, Hersberger KE, Messerli M, Leikola S, Horvat N, van Mil JWF, Kos M. PCNE definition of medication review: reaching agreement. Int J Clin Pharm. 2018 Oct;40(5):1199-1208. doi: 10.1007/s11096-018-0696-7. Epub 2018 Aug 2.</citation>
    <PMID>30073611</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Ljubljana</investigator_affiliation>
    <investigator_full_name>Mitja Kos</investigator_full_name>
    <investigator_title>prof. dr. Mitja Kos, Head of the Department of Social Pharmacy</investigator_title>
  </responsible_party>
  <keyword>adherence</keyword>
  <keyword>medicines use review</keyword>
  <keyword>drug related problems</keyword>
  <keyword>cognitive pharmaceutical service</keyword>
  <keyword>community pharmacy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We plan to publish the results of the study in a form of original research manuscript in an international journal with the impact factor. Any questions regarding the study protocol, process and analysis can be address to the principal investigator.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04417400
org study id: MZ 0120-321/2016-2
secondary id: P1-0189
nct id: NCT04417400
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Medicines Use Review service (PUZ) has been officially introduced in Slovenian pharmacy
      practice in 2015 and has been offered to pharmacy customers by pharmacist, certified to
      provide the service. Patients can to talk to a pharmacist and discuss their medicines, how
      they use it and any issues or question they might have. We designed a study to evaluate how
      Medicines Use Review (PUZ) work and how it is reaching the set objectives. The objectives of
      the PUZ service are to address actual patient medicines use and consequently improve
      medication adherence, identify and solve drug related problems and enhance medication
      knowledge. Pharmacists, who are certified to provide the service, recognized the patients,
      who might need the service and invited them to participate in the study. The study consisted
      of two visits in 12 weeks' time period. Patients, who decided to participate, were randomly
      allocated in two groups - intervention and control. Both groups were interviewed and
      fulfilled questionnaires at visit 1 (V1). Afterwards the test group patients received PUZ.
      After 12 weeks both groups attended the visit 2 (V2), where they were re-interviewed and
      fulfilled questionnaires again. After the study completion also the patients from control
      group received PUZ due to ethical reasons.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Upon enrollment patients were centrally randomized into two groups -test and control. Patients from the test group received MUR at visit 1. After 12 weeks both groups were reinterviewed. Upon study completion, patients from the control group received MUR due to ethical reasons, however the documentation was not part of the study anymore.
primary purpose: Health Services Research
masking: None (Open Label)
masking description: Patients and pharmacist were blind to the intervention at the time of enrollment.
Afterwards, pharmacist were notified about the randomization to be able to prepare for the patients that will receive MUR at the visit 1. Patients were blinded until the visit 1 - until after the baseline data collection"
measure: medication adherence
time frame: 12 weeks (V2-V1)
description: Self-reported medication adherence to multiple medications, evaluated by an 8-item Morisky Medication Adherence Scale (©MMAS-8) and scored with ©Morisky Widget MMAS-8 Software. MUR impact was defined as the relative difference in in MMAS-8 score after 12 weeks (V2-V1) between test and control group.
measure: drug-related problems
time frame: 12 weeks (V2-V1)
description: The changes in the proportion of manifested DRPs, the proportion of patients with at least one mDRPs, and the risk of the mDRPs between visits. This outcome only considered for the intervention group (test group), therefore the before-after analysis was applied.
measure: Medicine-associated burden
time frame: 12 weeks (V1-V2)
description: MUR impact on medicine-associated burden was defined as the mean relative difference in the score of Living with Medicines Questionnaire (©LMQ), visual analog scale (VAS) and each domain score between test and control group after 12 weeks (V1-V2).
measure: Patient information ('knowledge') regarding medicines
time frame: 12 weeks
description: Interview with the patients. Patients answered three questions regarding each of their regularly used prescription medicines: (i) "What are you taking the medicine for?", to state the purpose of medicine use; (ii) "How are you supposed to take the medicine?", to state the daily dose; and (iii) "Do you know of any special warnings regarding the medicine? If yes, which ones?". Accuracy of answers regarding the purpose of medicine and its daily dose were checked by comparing them with either physician instructions or, when physician instructions were unavailable, Summary of Product Characteristics (SmPC). Answers were deemed to be 'correct' if they matched the information in these sources, 'incorrect' if they did not match or 'not known' if patients responded with "I don't know" or 'no'. Proportions of correct and incorrect answers per patient-medicine, and proportions of improvement or deterioration in given information between visits for the test and control group, were assessed.
arm group label: Intervention
arm group type: Experimental
description: Patients who received MUR at visit 1
arm group label: Control
arm group type: No Intervention
description: Patients received standard care and MUR after visit 2 (upon completion of the study)
intervention type: Behavioral
intervention name: medicines use review
description: The provision of MUR service as defined in the SOP MUR (Slovene Chamber of Pharmacies). It is classified as a type 2a review (PCNE typology) and it is intended for the patients to support them in regular and proper medicines use. MUR is performed based on medication history and information provided by the patient in a purposely scheduled conversation with the pharmacist. Pharmacists must be certified to provide MUR. MUR goal is to identify DRPs and recommend interventions to resolve them. During the MUR interview, the pharmacist completes a working sheet that records information regarding medicines, identified DRPs and recommended interventions. After the MUR interview, patients are provided with a personal medicines card that contains all the information that is needed to support effective and safe medicines use (dosing regimen, taking with/without food, special warnings, recommendations, etc.).
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Igor Locatelli, M.Pharm, PhD
role: Study Director
affiliation: University of Ljubljana
last name: Mitja Kos, MPharm, PhD
role: Principal Investigator
affiliation: University of Ljubljana
last name: Urska Nabergoj Makovec, MPharm
role: Study Chair
affiliation: University of Ljubljana
facility: 
facility: 
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facility: 
country: Slovenia
citation: Nabergoj Makovec U, Kos M, Pisk N. Community pharmacists' perspectives on implementation of Medicines Use Review in Slovenia. Int J Clin Pharm. 2018 Oct;40(5):1180-1188. doi: 10.1007/s11096-018-0644-6. Epub 2018 Jun 16.
PMID: 29909563
citation: Griese-Mammen N, Hersberger KE, Messerli M, Leikola S, Horvat N, van Mil JWF, Kos M. PCNE definition of medication review: reaching agreement. Int J Clin Pharm. 2018 Oct;40(5):1199-1208. doi: 10.1007/s11096-018-0696-7. Epub 2018 Aug 2.
PMID: 30073611
responsible party type: Sponsor-Investigator
investigator affiliation: University of Ljubljana
investigator full name: Mitja Kos
investigator title: prof. dr. Mitja Kos, Head of the Department of Social Pharmacy
sharing ipd: No
ipd description: We plan to publish the results of the study in a form of original research manuscript in an international journal with the impact factor. Any questions regarding the study protocol, process and analysis can be address to the principal investigator.