Clinical trial NCT03321058: Polymedication-Check With Insight in Patients' Medication Organisation and Comprehension of Generics
Official title: Polymedikations-Check Und Medikamenten-Organisation im Alltag
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Therapy Management
Medication Adherence
Keywords: Drug Substitution
Multicompartment Compliance Aid
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2017-10-25
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises adults (18 years and older) with at least 4 prescribed medicines which they are taking for at least 3 months. One of those medicines must be a generic drug, one must be prescribed for a cardiovascular condition (ATC C01-10). Patients cannot have their medication provided in a Multicompartment Compliance Aid or a similar device by a specific service like home care, pharmacy or home for elderly.

Brief summary: Patients using multiple drugs including generics have found different solutions to manage their medication. During a Polymedication-Check (medication review type 2a service in community pharmacies) additional information about the organisation of patients' medication in daily life will be compiled in Swiss community pharmacies. Data will allow to better address patients' needs in their medication organisation and comprehension of generics.


Eligibility criteria: Inclusion Criteria:

* at least 4 medicines for at least 3 months
* at least 1 generic drug
* at least 1 medicine of ATC code cardiovascular system (C01-10)

Exclusion Criteria:

* medication provided in Multicompartment Compliance Aid or similar device by specific service (pharmacy, elderly home, home care)

Primary outcomes:
measure: Insight in patients' organisation of polymedication
timeFrame: retrospective 3 months
measure: Insight in patients' comprehension of generics
timeFrame: retrospective 3 months
Secondary outcomes:
measure: Number of patients using Multicompartment Compliance Aids.
timeFrame: retrospective 3 months
measure: Number of substitutable medicines.
timeFrame: retrospective 3 months
measure: Swallowing difficulties
timeFrame: retrospective 3 months
measure: Recommended use of Multicompartment Compliance Aids
timeFrame: retrospective 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
state: Basel-Stadt
Study officials:
References:
citation: Messerli M, Blozik E, Vriends N, Hersberger KE. Impact of a community pharmacist-led medication review on medicines use in patients on polypharmacy--a prospective randomised controlled trial. BMC Health Serv Res. 2016 Apr 23;16:145. doi: 10.1186/s12913-016-1384-8.
citation: Olsson E, Kalvemark Sporrong S. Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin. Int J Pharm Pract. 2012 Dec;20(6):377-83. doi: 10.1111/j.2042-7174.2012.00214.x. Epub 2012 Jun 1.
citation: Hakonsen H, Eilertsen M, Borge H, Toverud EL. Generic substitution: additional challenge for adherence in hypertensive patients? Curr Med Res Opin. 2009 Oct;25(10):2515-21. doi: 10.1185/03007990903192223.
citation: Nunney J, Raynor DK, Knapp P, Closs SJ. How do the attitudes and beliefs of older people and healthcare professionals impact on the use of multi-compartment compliance aids?: a qualitative study using grounded theory. Drugs Aging. 2011 May 1;28(5):403-14. doi: 10.2165/11587180-000000000-00000.