Polymedication Check (PMCeval)
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Purpose
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 RCT.
| Condition | Intervention |
|---|---|
|
Polypharmacy (= Patients on Multiple Medicines on Long Term Conditions) |
Behavioral: Medication review |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
| Official Title: | Polymedication Check - Evaluation of the Impact of Community Pharmacy Based Medication Review on Medicines Use and Humanistic Outcomes |
- Medication possession ratio (MPR), gaps and persistence in medicines use [ Time Frame: Seven months after recruitment ] [ Designated as safety issue: No ]Improvement of adherence seven months after 'Polymedication-Check' using medication possession ratio (MPR), gaps and persistence out of history records from community pharmacy.
- Time to planned or unplanned consulting with a physician or hospitalisation [ Time Frame: Seven months after recruitment ] [ Designated as safety issue: No ]Time to planned or unplanned consulting with a physician or hospitalisation
- Patient knowledge about his medicines [ Time Frame: After two weeks, four and seven months after recruitment ] [ Designated as safety issue: No ]Patient knowledge about his medicines use, assesed through PMC (intervention goup) and two telephone interviews (both groups)
- Self reported adherence [ Time Frame: At study start and two weeks, four and seven months after after recruitment ] [ Designated as safety issue: No ]Self report of adherence: is assesed with self administaired questionnaires and telefone interviews
- Patients safety [ Time Frame: After two weeks, four and seven months after recruitment ] [ Designated as safety issue: Yes ]Patients safety is assesed through a)telefone interview with a focus on perceived safety and b) number of drug related problems adressed and solved at study end.
- Use of compliance aids [ Time Frame: At study start and two weeks, four and seven months after after recruitment ] [ Designated as safety issue: No ]Compliance aids may be in use prior to recruitment, recommended after intervention by pharmacist, recommendation can be refused or accepted and the compliance aid can be filled by the patient himself or specialised service from the pharmacy.
| Estimated Enrollment: | 800 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control group
Patients get no intervention at study start, but only at study end after seven months.
|
|
|
Active Comparator: Intervention group
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
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 pharmcist to patient with polymedication (n>3 drugs) on long term conditions (> months). This specialised medication review follows a structured predifined protocol and is reimbursed by swiss health insurances. As an outcome, pharmacist may install a compliance support e.g. weekly filled pill organizer. Other Name: Polymedication Check
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|
Observational arm
If participants after recruitment violate inclusion criteria (e.g. change from autonome 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
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 pharmcist to patient with polymedication (n>3 drugs) on long term conditions (> months). This specialised medication review follows a structured predifined protocol and is reimbursed by swiss health insurances. As an outcome, pharmacist may install a compliance support e.g. weekly filled pill organizer. Other Name: Polymedication Check
|
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, safty of medicines use and patients management of polypharmacy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- more than 3 drugs over at least 3 months prior to recruitment
- german or french language (written and spoken)
- medcines use in selfmanagament
Exclusion Criteria:
- provision of Polymedication Check in the past
- living in a nursing home
- use of prefilled pill organiser or indiviudally blistered medication
Contacts and Locations| Contact: Markus Messerli, M Sc | 0041 61 267 15 29 | markus.messerli@unibas.ch |
| Switzerland | |
| Pharmaceutical Care Research Group, University of Basel | Recruiting |
| Basel, Switzerland, 4056 | |
| Contact: Markus Messerli, M Sc 0041 61 267 15 29 markus.messerli@unibas.ch | |
| Principal Investigator: Markus Messerli, M Sc | |
| Principal Investigator: | Kurt E Hersberger, Prof. | Pharmaceutical Care Research Group, University of Basel |
More Information
Additional Information:
Publications:
| Responsible Party: | Kurt Hersberger, Professor, University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT01739816 History of Changes |
| Other Study ID Numbers: | PMCeval |
| Study First Received: | November 27, 2012 |
| Last Updated: | November 27, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Basel, Switzerland:
|
Compliance Adherence Polypharmacy Medicines use Medication review |
Pharmaceutical care Primary care Drug related problem Patient safety |
ClinicalTrials.gov processed this record on May 16, 2013