NCT01739816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

1.7 years

First QC Date

November 27, 2012

Last Update Submit

April 8, 2014

Conditions

Polypharmacy

Keywords

ComplianceAdherencePolypharmacyMedicines useMedication reviewPharmaceutical carePrimary careDrug related problemPatient safety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to planned or unplanned consulting with a physician or hospitalisation

    Seven months after recruitment

  • Patient knowledge about his medicines

    After two weeks, four and seven months after recruitment

  • Self reported adherence

    At study start and two weeks, four and seven months after after recruitment

  • Patients safety

    After two weeks, four and seven months after recruitment

Other Outcomes (1)

  • Use of compliance aids

    At study start and two weeks, four and seven months after after recruitment

Study Arms (3)

Control group

NO INTERVENTION

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

Intervention group

ACTIVE COMPARATOR

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

Observational arm

OTHER

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

Interventions

Medication reviewBEHAVIORAL

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.

Also known as: Polymedication Check
Intervention groupObservational arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaceutical Care Research Group, University of Basel

Basel, Basel, 4056, Switzerland

Location

Related Publications (6)

  • 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.

    PMID: 22486599BACKGROUND

  • 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.

    PMID: 17922887BACKGROUND

  • 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.

    PMID: 17004019BACKGROUND

  • 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.

    PMID: 21428465BACKGROUND

  • 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.

    PMID: 21385240BACKGROUND

  • 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.

    PMID: 27108410DERIVED

Related Links

MeSH Terms

Conditions

Patient Compliance

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Kurt E Hersberger, Prof.

    University of Basel

    STUDY DIRECTOR

  • Markus Messerli, MSc

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 4, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

CH(1)