Clinical trial NCT04417400: Evaluation of Medicines Use Review in Slovenia
Official title: Benefits of Medicines Use Review Service in Slovenia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medicines Use Review Service
Multiple Medication
Adherence, Medication
Keywords: adherence
medicines use review
drug related problems
cognitive pharmaceutical service
community pharmacy
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
Collaborators: name: Comunity pharmacy Celjske lekarne
name: Comunity pharmacy Gorenjske lekarne
name: Comunity pharmacy Goriška lekarna Nova Gorica
name: Comunity pharmacy Javni zdravstveni zavod Mariborske lekarne Maribor
name: Comunity pharmacy Kraške lekarne Ilirska Bistrica
name: Comunity pharmacy Lekarna Brežice
name: Comunity pharmacy Lekarna Kočevje
name: Comunity pharmacy Lekarna Ljubljana
name: Comunity pharmacy Lekarna Ormož
name: Comunity pharmacy Lekarna Sevnica
name: Comunity pharmacy Lekarne Ptuj
name: Comunity pharmacy Obalne lekarne Koper
name: Comunity pharmacy Pomurske lekarne Murska Sobota
name: Comunity pharmacy Žalske lekarne Žalec
First posted: 2020-06-04
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: medication adherence
timeFrame: 12 weeks (V2-V1)
Secondary outcomes:
measure: drug-related problems
timeFrame: 12 weeks (V2-V1)
measure: Medicine-associated burden
timeFrame: 12 weeks (V1-V2)
measure: Patient information ('knowledge') regarding medicines
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brežice
country: Slovenia
facility: Community pharmacy "Lekarna Brežice"
city: Celje
country: Slovenia
facility: Community pharmacy "Celjske lekarne javni zavod"
city: Ilirska Bistrica
country: Slovenia
facility: Community pharmacy "Kraške lekarne Ilirska Bistrica"
city: Koper
country: Slovenia
facility: Community pharmacy "Obalne lekarne Koper"
city: Kočevje
country: Slovenia
facility: Community pharmacy "Lekarna Kočevje"
city: Kranj
country: Slovenia
facility: Community pharmacy " Gorenjske lekarne"
city: Ljubljana
country: Slovenia
facility: Community pharmacy "Lekarna Ljubljana"
city: Maribor
country: Slovenia
facility: Community pharmacy "Javni zdravstveni zavod Mariborske lekarne Maribor"
city: Murska Sobota
country: Slovenia
facility: Community pharmacy "Pomurske lekarne Murska Sobota"
city: Nova Gorica
country: Slovenia
facility: Community pharmacy "Goriška lekarna Nova Gorica"
city: Ormož
country: Slovenia
facility: Community pharmacy "Lekarna Ormož"
city: Ptuj
country: Slovenia
facility: Community pharmacy "Lekarne Ptuj"
city: Sevnica
country: Slovenia
facility: Community pharmacy "Lekarna Sevnica"
city: Žalec
country: Slovenia
facility: Community pharmacy "Žalske lekarne Žalec"
Study officials:
affiliation: University of Ljubljana
name: Igor Locatelli, M.Pharm, PhD
role: STUDY_DIRECTOR
affiliation: University of Ljubljana
name: Mitja Kos, MPharm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ljubljana
name: Urska Nabergoj Makovec, MPharm
role: STUDY_CHAIR
References:
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: 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: 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.