Polymedication Check - a Randomised Controlled Trial

NCT ID: NCT01739816

Last Updated: 2014-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-03-31

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.

Conditions

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Polypharmacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group

Patients get no intervention at study start, but only at study end after seven months.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type ACTIVE_COMPARATOR

Medication review

Intervention Type BEHAVIORAL

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.

Observational arm

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.

Group Type OTHER

Medication review

Intervention Type BEHAVIORAL

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.

Interventions

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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 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Polymedication Check

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

Polyclinique Médicale Universitaire, PMU, Lausanne

UNKNOWN

Sponsor Role collaborator

Swiss Pharmacy Association, pharmaSuisse

UNKNOWN

Sponsor Role collaborator

Kurt Hersberger

OTHER

Sponsor Role lead

Responsible Party

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Kurt Hersberger

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kurt E Hersberger, Prof.

Role: STUDY_DIRECTOR

University of Basel

Markus Messerli, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

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Pharmaceutical Care Research Group, University of Basel

Basel, Basel, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 22486599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17922887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17004019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21428465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21385240 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27108410 (View on PubMed)

Related Links

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http://www.pharmacare.unibas.ch

For recent publications, see 'Publications' -\> 'Publications' and 'Posters'

http://www.pcne.org/sig/MedRev/medication-review.php

For information concerning 'Medication Review'

Other Identifiers

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evalPMC

Identifier Type: -

Identifier Source: org_study_id

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