Evaluation of Medicines Use Review in Slovenia (SLOPUZ)

June 1, 2020 updated by: Mitja Kos

Benefits of Medicines Use Review Service in Slovenia: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • 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

  • Slovenia
      • Brežice, Slovenia, 8250
        • Community pharmacy "Lekarna Brežice"
      • Celje, Slovenia, 3000
        • Community pharmacy "Celjske lekarne javni zavod"
      • Ilirska Bistrica, Slovenia, 6250
        • Community pharmacy "Kraške lekarne Ilirska Bistrica"
      • Koper, Slovenia, 6000
        • Community pharmacy "Obalne lekarne Koper"
      • Kočevje, Slovenia, 1330
        • Community pharmacy "Lekarna Kočevje"
      • Kranj, Slovenia, 4000
        • Community pharmacy " Gorenjske lekarne"
      • Ljubljana, Slovenia, 1000
        • Community pharmacy "Lekarna Ljubljana"
      • Maribor, Slovenia, 2000
        • Community pharmacy "Javni zdravstveni zavod Mariborske lekarne Maribor"
      • Murska Sobota, Slovenia, 9000
        • Community pharmacy "Pomurske lekarne Murska Sobota"
      • Nova Gorica, Slovenia, 5000
        • Community pharmacy "Goriška lekarna Nova Gorica"
      • Ormož, Slovenia, 2270
        • Community pharmacy "Lekarna Ormož"
      • Ptuj, Slovenia, 2250
        • Community pharmacy "Lekarne Ptuj"
      • Sevnica, Slovenia, 8290
        • Community pharmacy "Lekarna Sevnica"
      • Žalec, Slovenia, 3310
        • Community pharmacy "Žalske lekarne Žalec"

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least one prescription medicine for a chronic condition for at least six months
  • deemed to be suitable for MUR by a pharmacist, certified to provide the MUR service;
  • ability to communicate in Slovenian; The inclusion of patients was performed in accordance with the SOP MUR, to reflect how patients are generally offered MUR service in Slovenia.

Exclusion Criteria:

  • urgent need of MUR (the service delay due to randomization would risk their health);
  • referred for MUR by a healthcare professional (general practitioner, nurse, etc.);
  • the patient's carer, rather than the patient themselves, was able to attend the interviews and receive MUR;
  • previously received MUR or an advanced medication review;
  • difficulties understanding, communicating or other issues (vision, hearing) that might affect study outcomes.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Patients who received MUR at visit 1
Behavioral: medicines use review
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.).
No Intervention: Control
Patients received standard care and MUR after visit 2 (upon completion of the study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medication adherence
Time Frame: 12 weeks (V2-V1)
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.
12 weeks (V2-V1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drug-related problems
Time Frame: 12 weeks (V2-V1)
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.
12 weeks (V2-V1)
Medicine-associated burden
Time Frame: 12 weeks (V1-V2)
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).
12 weeks (V1-V2)
Patient information ('knowledge') regarding medicines
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

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

Sponsor

Mitja Kos

Collaborators

Comunity pharmacy Celjske lekarne
Comunity pharmacy Gorenjske lekarne
Comunity pharmacy Goriška lekarna Nova Gorica
Comunity pharmacy Javni zdravstveni zavod Mariborske lekarne Maribor
Comunity pharmacy Kraške lekarne Ilirska Bistrica
Comunity pharmacy Lekarna Brežice
Comunity pharmacy Lekarna Kočevje
Comunity pharmacy Lekarna Ljubljana
Comunity pharmacy Lekarna Ormož
Comunity pharmacy Lekarna Sevnica
Comunity pharmacy Lekarne Ptuj
Comunity pharmacy Obalne lekarne Koper
Comunity pharmacy Pomurske lekarne Murska Sobota
Comunity pharmacy Žalske lekarne Žalec

Investigators

  • Study Director: Igor Locatelli, M.Pharm, PhD, University of Ljubljana
  • Principal Investigator: Mitja Kos, MPharm, PhD, University of Ljubljana
  • Study Chair: Urska Nabergoj Makovec, MPharm, University of Ljubljana

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

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)

May 9, 2017

Primary Completion (Actual)

September 16, 2017

Study Completion (Actual)

September 16, 2017

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MZ 0120-321/2016-2
  • P1-0189 (Other Grant/Funding Number: A PhD under research group funded by Slovene Research Agency.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan 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.

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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