AzTrials
AzTrials

Medicines Use Review ServiceSLOPUZNCT04417400

Evaluation of Medicines Use Review in Slovenia

A study testing medicines use review in people with Medicines Use Review Service and Multiple Medication, run by Mitja Kos at 14 sites in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
medicines use review
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
14 sitesSlovenia
Study dates
9 May 2017to 16 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Slovenia14 sites

  • Community pharmacy "Lekarna Brežice"

    Brežice, 8250

  • Community pharmacy "Celjske lekarne javni zavod"

    Celje, 3000

  • Community pharmacy "Kraške lekarne Ilirska Bistrica"

    Ilirska Bistrica, 6250

  • Community pharmacy "Lekarna Kočevje"

    Kočevje, 1330

  • Community pharmacy "Obalne lekarne Koper"

    Koper, 6000

  • Community pharmacy " Gorenjske lekarne"

    Kranj, 4000

  • Community pharmacy "Lekarna Ljubljana"

    Ljubljana, 1000

  • Community pharmacy "Javni zdravstveni zavod Mariborske lekarne Maribor"

    Maribor, 2000

  • Community pharmacy "Pomurske lekarne Murska Sobota"

    Murska Sobota, 9000

  • Community pharmacy "Goriška lekarna Nova Gorica"

    Nova Gorica, 5000

  • Community pharmacy "Lekarna Ormož"

    Ormoz, 2270

  • Community pharmacy "Lekarne Ptuj"

    Ptuj, 2250

  • Community pharmacy "Lekarna Sevnica"

    Sevnica, 8290

  • Community pharmacy "Žalske lekarne Žalec"

    Žalec, 3310

Other trials in Slovenia

About this study

Official title: 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.

Being tested
medicines use review
Keywords
adherence, medicines use review, drug related problems, cognitive pharmaceutical service, community pharmacy
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • medicines use reviewBehavioural

    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.).

Study groups in NCT04417400
Study groupRoleWhat they receive
InterventionExperimentalPatients who received MUR at visit 1
Receives: Behavioral: medicines use review
ControlNo interventionPatients received standard care and MUR after visit 2 (upon completion of the study)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. medication adherence

    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.

    Measured: 12 weeks (V2-V1)

Secondary outcomes (3)

  1. drug-related problems

    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.

    Measured: 12 weeks (V2-V1)

  2. Medicine-associated burden

    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).

    Measured: 12 weeks (V1-V2)

  3. Patient information ('knowledge') regarding medicines

    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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start9 May 2017
  3. Primary completion16 Sep 2017
  4. Study completion16 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04417400
Sponsor's protocol ID
MZ 0120-321/2016-2
Other IDs
P1-0189
Acronym
SLOPUZ
Status last verified
Jun 2020
First submitted
1 Jun 2020
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 29909563

  • 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.

    PubMed 30073611

  • Nabergoj Makovec U, Locatelli I, Kos M. Improved adherence with Medicines Use Review service in Slovenia: a randomized controlled trial. BMC Health Serv Res. 2021 Mar 22;21(1):266. doi: 10.1186/s12913-021-06223-8.

    PubMed 33752647

Questions about this trial

What is this clinical trial studying?

A study testing medicines use review in people with Medicines Use Review Service and Multiple Medication, run by Mitja Kos at 14 sites in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

medication adherence (time frame: 12 weeks (V2-V1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417400, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in