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
|Condition or disease||Intervention/treatment||Phase|
|Medicines Use Review Service Multiple Medication Adherence, Medication||Behavioral: medicines use review||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|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)|
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|
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)
- 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.
- 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.
- 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).
- 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.
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
|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|
|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|