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NCT Number: NCT01739816

Polymedication Check - a Randomised Controlled Trial

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.

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Key information

Conditions

Polypharmacy Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharmaceutical Care Research Group, University of Basel

Basel, 4056, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication review

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.

Other names: Polymedication Check

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kurt Hersberger

Other

Collaborators

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

Registry information

Official study title

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

Acronym: evalPMC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2012
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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