Evaluation of Medicines Use Review in Slovenia

NCT ID: NCT04417400

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-09
• Study Completion Date: 2017-09-16

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.

Conditions

Medicines Use Review Service; Multiple Medication; Adherence, Medication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Patients who received MUR at visit 1

Group Type: EXPERIMENTAL

medicines use review

Intervention Type: BEHAVIORAL

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.).

Control

Patients received standard care and MUR after visit 2 (upon completion of the study)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comunity pharmacy Celjske lekarne

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Gorenjske lekarne

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Goriška lekarna Nova Gorica

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Javni zdravstveni zavod Mariborske lekarne Maribor

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Kraške lekarne Ilirska Bistrica

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Lekarna Brežice

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Lekarna Kočevje

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Lekarna Ljubljana

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Lekarna Ormož

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Lekarna Sevnica

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Lekarne Ptuj

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Obalne lekarne Koper

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Pomurske lekarne Murska Sobota

UNKNOWN

Sponsor Role: collaborator

Comunity pharmacy Žalske lekarne Žalec

UNKNOWN

Sponsor Role: collaborator

Mitja Kos

OTHER

Sponsor Role: lead

Responsible Party

Mitja Kos

prof. dr. Mitja Kos, Head of the Department of Social Pharmacy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Igor Locatelli, M.Pharm, PhD

Role: STUDY_DIRECTOR

University of Ljubljana

Mitja Kos, MPharm, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ljubljana

Urska Nabergoj Makovec, MPharm

Role: STUDY_CHAIR

University of Ljubljana

Locations

Community pharmacy "Lekarna Brežice"

Brežice, , Slovenia

Community pharmacy "Celjske lekarne javni zavod"

Celje, , Slovenia

Community pharmacy "Kraške lekarne Ilirska Bistrica"

Ilirska Bistrica, , Slovenia

Community pharmacy "Lekarna Kočevje"

Kočevje, , Slovenia

Community pharmacy "Obalne lekarne Koper"

Koper, , Slovenia

Community pharmacy " Gorenjske lekarne"

Kranj, , Slovenia

Community pharmacy "Lekarna Ljubljana"

Ljubljana, , Slovenia

Community pharmacy "Javni zdravstveni zavod Mariborske lekarne Maribor"

Maribor, , Slovenia

Community pharmacy "Pomurske lekarne Murska Sobota"

Murska Sobota, , Slovenia

Community pharmacy "Goriška lekarna Nova Gorica"

Nova Gorica, , Slovenia

Community pharmacy "Lekarna Ormož"

Ormož, , Slovenia

Community pharmacy "Lekarne Ptuj"

Ptuj, , Slovenia

Community pharmacy "Lekarna Sevnica"

Sevnica, , Slovenia

Community pharmacy "Žalske lekarne Žalec"

Žalec, , Slovenia

Countries

Slovenia

References

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.

Reference Type: BACKGROUND

PMID: 29909563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30073611 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33752647 (View on PubMed)

Other Identifiers

P1-0189

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MZ 0120-321/2016-2

Identifier Type: -

Identifier Source: org_study_id