Polymedication Check - a Randomised Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Polymedication Check - Evaluation of the Impact of Community Pharmacy Based Medication Review on Medicines Use and Humanistic Outcomes

Conditions
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Polypharmacy

Intervention / Treatment
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* Behavioral: Medication review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients get no intervention at study start, but only at study end after seven months. | |
| Active Comparator: Intervention group<br>At the beginning and at the end of the study, this group receives a pharmacist's led medication review focusing on daily medicines use (= Polymedication Check). | Behavioral: Medication review<br>* Polymedication Check (PMC) is a pharmacist's led medication review focusing medicines management, adherence issues and other drug related problems. The PMC has been implemented in 2010 as a new cognitive service provided by any community pharmacist to patient with polypharmacy (n>3 drugs) on long term conditions (> months). This specialised medication review follows a structured predefined protocol and is reimbursed by swiss health insurances. As an outcome, pharmacist may install a compliance support e.g. weekly filled pill organizer.<br>* Other names: Polymedication Check;|
| Other: Observational arm<br>If participants after recruitment violate inclusion criteria (e.g. change from autonomous medication management to external home care) or insists on intervention despite being randomised to control group or patient condition forces pharmacist to provide a PMC. | Behavioral: Medication review<br>* Polymedication Check (PMC) is a pharmacist's led medication review focusing medicines management, adherence issues and other drug related problems. The PMC has been implemented in 2010 as a new cognitive service provided by any community pharmacist to patient with polypharmacy (n>3 drugs) on long term conditions (> months). This specialised medication review follows a structured predefined protocol and is reimbursed by swiss health insurances. As an outcome, pharmacist may install a compliance support e.g. weekly filled pill organizer.<br>* Other names: Polymedication Check;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication possession ratio (MPR), gaps and persistence in medicines use | Improvement of adherence seven months after 'Polymedication-Check' using medication possession ratio (MPR), gaps and persistence out of history records from community pharmacy. | Seven months after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to planned or unplanned consulting with a physician or hospitalisation | Time to planned or unplanned consulting with a physician or hospitalisation | Seven months after recruitment | 
| Patient knowledge about his medicines | Patient knowledge about his medicines use, assessed through PMC (intervention goup) and two telephone interviews (both groups) | After two weeks, four and seven months after recruitment | 
| Self reported adherence | Self report of adherence: is assessed with self administrated questionnaires and telephone interviews | At study start and two weeks, four and seven months after after recruitment | 
| Patients safety | Patients safety is assessed through a) telephone interview with a focus on perceived safety and b) number of drug related problems addressed and solved at study end. | After two weeks, four and seven months after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compliance, Adherence, Polypharmacy, Medicines use, Medication review, Pharmaceutical care, Primary care, Drug related problem, Patient safety