Polymedication Check - a Randomised Controlled Trial (evalPMC)

April 8, 2014 updated by: Kurt Hersberger

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4056
        • Pharmaceutical Care Research Group, University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 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.

Other Names:
  • Polymedication Check
Other: 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.
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 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.

Other Names:
  • Polymedication Check

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication possession ratio (MPR), gaps and persistence in medicines use
Time Frame: Seven months after recruitment
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 Frame: Seven months after recruitment
Time to planned or unplanned consulting with a physician or hospitalisation
Seven months after recruitment
Patient knowledge about his medicines
Time Frame: After two weeks, four and seven months after recruitment
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
Time Frame: At study start and two weeks, four and seven months after after recruitment
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
Time Frame: After two weeks, four and seven months after recruitment
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of compliance aids
Time Frame: At study start and two weeks, four and seven months after after recruitment
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.
At study start and two weeks, four and seven months after after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kurt Hersberger

Collaborators

University Hospital, Basel, Switzerland
University of Basel
Polyclinique Médicale Universitaire, PMU, Lausanne
Swiss Pharmacy Association, pharmaSuisse

Investigators

  • Study Director: Kurt E Hersberger, Prof., University of Basel
  • Principal Investigator: Markus Messerli, MSc, University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • evalPMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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