Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04417400
Previous Study | Return to List | Next Study

Evaluation of Medicines Use Review in Slovenia (SLOPUZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417400
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
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
Information provided by (Responsible Party):
Mitja Kos, University of Ljubljana

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.

Condition or disease Intervention/treatment Phase
Medicines Use Review Service Multiple Medication Adherence, Medication Behavioral: medicines use review Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
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.
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"

Primary Purpose: Health Services Research
Official Title: Benefits of Medicines Use Review Service in Slovenia: a Randomized Controlled Trial
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : September 16, 2017
Actual Study Completion Date : September 16, 2017

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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417400


Locations
Layout table for location information
Slovenia
Community pharmacy "Lekarna Brežice"
Brežice, Slovenia, 8250
Community pharmacy "Celjske lekarne javni zavod"
Celje, Slovenia, 3000
Community pharmacy "Kraške lekarne Ilirska Bistrica"
Ilirska Bistrica, Slovenia, 6250
Community pharmacy "Obalne lekarne Koper"
Koper, Slovenia, 6000
Community pharmacy "Lekarna Kočevje"
Kočevje, Slovenia, 1330
Community pharmacy " Gorenjske lekarne"
Kranj, Slovenia, 4000
Community pharmacy "Lekarna Ljubljana"
Ljubljana, Slovenia, 1000
Community pharmacy "Javni zdravstveni zavod Mariborske lekarne Maribor"
Maribor, Slovenia, 2000
Community pharmacy "Pomurske lekarne Murska Sobota"
Murska Sobota, Slovenia, 9000
Community pharmacy "Goriška lekarna Nova Gorica"
Nova Gorica, Slovenia, 5000
Community pharmacy "Lekarna Ormož"
Ormož, Slovenia, 2270
Community pharmacy "Lekarne Ptuj"
Ptuj, Slovenia, 2250
Community pharmacy "Lekarna Sevnica"
Sevnica, Slovenia, 8290
Community pharmacy "Žalske lekarne Žalec"
Žalec, Slovenia, 3310
Sponsors and Collaborators
Mitja Kos
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
Layout table for investigator information
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mitja Kos, prof. dr. Mitja Kos, Head of the Department of Social Pharmacy, University of Ljubljana
ClinicalTrials.gov Identifier: NCT04417400    
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. )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mitja Kos, University of Ljubljana:
adherence
medicines use review
drug related problems
cognitive pharmaceutical service
community pharmacy