Clinical trial NCT01739816: Polymedication Check - a Randomised Controlled Trial
Official title: Polymedication Check - Evaluation of the Impact of Community Pharmacy Based Medication Review on Medicines Use and Humanistic Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Keywords: Compliance
Adherence
Polypharmacy
Medicines use
Medication review
Pharmaceutical care
Primary care
Drug related problem
Patient safety
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: University Hospital, Basel, Switzerland
name: Polyclinique Médicale Universitaire, PMU, Lausanne
name: Swiss Pharmacy Association, pharmaSuisse
First posted: 2012-12-04
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Since October 2010, Swiss community pharmacies can offer a 'Polymedication Check' (PMC) to patients on ≥4 prescribed drugs taken over ≥3 months.

Aims:

To evaluate first experiences shortly after implementation, missed pharmaceutical care issues and barriers to implementation on pharmacist's level as well as patient's acceptance through qualitative and descriptive studies To evaluate the impact of PMC in Swiss primary Care and to evaluate economic, clinical and humanistic outcomes in a subsequent randomized controlled trial.

Detailed description: Evaluating the newly implemented Swiss 'Polymedication-Check', a specialised medication review and screening for adherence issues, offers a large field of interesting research questions. Using the current PMC-Protocol as a structured interview guide, pharmacists are able to document their counselling on medication use issues and other drug related problems.

In a randomized-controlled trial we aim at analysing 800 recruited patients from 70 study pharmacies during seven months. Patients were recruited in the regions Basel, Aargau-Solothurn, Waadt in Switzerland and randomised using 1:1 block randomisation.

Primary outcome focuses on the improvement of adherence and persistence after 'Polymedication Check' (using medication possession ratio (MPR), gaps in medicines history records and patient's interviews).

Second outcomes are time to planned or unplanned consulting with a physician or hospitalisation, knowledge, safety of medicines use and patients management of polypharmacy.

Eligibility criteria: Inclusion Criteria:

* more than 3 drugs over at least 3 months prior to recruitment
* german or french language (written and spoken)
* medicines use in self management

Exclusion Criteria:

* provision of Polymedication Check in the past
* living in a nursing home
* use of prefilled pill organiser or individually blistered medication

Primary outcomes:
measure: Medication possession ratio (MPR), gaps and persistence in medicines use
timeFrame: Seven months after recruitment
Secondary outcomes:
measure: Time to planned or unplanned consulting with a physician or hospitalisation
timeFrame: Seven months after recruitment
measure: Patient knowledge about his medicines
timeFrame: After two weeks, four and seven months after recruitment
measure: Self reported adherence
timeFrame: At study start and two weeks, four and seven months after after recruitment
measure: Patients safety
timeFrame: After two weeks, four and seven months after recruitment
Other outcomes:
measure: Use of compliance aids
timeFrame: At study start and two weeks, four and seven months after after recruitment
Locations:
city: Basel
country: Switzerland
facility: Pharmaceutical Care Research Group, University of Basel
Study officials:
affiliation: University of Basel
name: Kurt E Hersberger, Prof.
role: STUDY_DIRECTOR
affiliation: University of Basel
name: Markus Messerli, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x.
citation: Krska J, Avery AJ; Community Pharmacy Medicines Management Project Evaluation Team. Evaluation of medication reviews conducted by community pharmacists: a quantitative analysis of documented issues and recommendations. Br J Clin Pharmacol. 2008 Mar;65(3):386-96. doi: 10.1111/j.1365-2125.2007.03022.x. Epub 2007 Oct 8.
citation: Clifford S, Barber N, Elliott R, Hartley E, Horne R. Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci. 2006 Jun;28(3):165-70. doi: 10.1007/s11096-006-9026-6. Epub 2006 Sep 27.
citation: Kwint HF, Faber A, Gussekloo J, Bouvy ML. Effects of medication review on drug-related problems in patients using automated drug-dispensing systems: a pragmatic randomized controlled study. Drugs Aging. 2011 Apr 1;28(4):305-14. doi: 10.2165/11586850-000000000-00000.
citation: Bryant LJ, Coster G, Gamble GD, McCormick RN. The General Practitioner-Pharmacist Collaboration (GPPC) study: a randomised controlled trial of clinical medication reviews in community pharmacy. Int J Pharm Pract. 2011 Apr;19(2):94-105. doi: 10.1111/j.2042-7174.2010.00079.x. Epub 2011 Feb 25.
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.