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Polymedication Check - a Randomised Controlled Trial (evalPMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01739816
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : April 9, 2014
Sponsor:
Collaborators:
University of Basel
University Hospital, Basel, Switzerland
Polyclinique Médicale Universitaire, PMU, Lausanne
Swiss Pharmacy Association, pharmaSuisse
Information provided by (Responsible Party):
Kurt Hersberger, University Hospital, Basel, Switzerland

Study Description
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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.


Condition or disease Intervention/treatment Phase
Polypharmacy Behavioral: Medication review Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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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 Name: Polymedication Check
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 Name: Polymedication Check


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739816


Locations
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Switzerland
Pharmaceutical Care Research Group, University of Basel
Basel, Switzerland, 4056
Sponsors and Collaborators
Kurt Hersberger
University of Basel
University Hospital, Basel, Switzerland
Polyclinique Médicale Universitaire, PMU, Lausanne
Swiss Pharmacy Association, pharmaSuisse
Investigators
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Study Director: Kurt E Hersberger, Prof. University of Basel
Principal Investigator: Markus Messerli, MSc University of Basel
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kurt Hersberger, Professor, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01739816    
Other Study ID Numbers: evalPMC
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by Kurt Hersberger, University Hospital, Basel, Switzerland:
Compliance
Adherence
Polypharmacy
Medicines use
Medication review
 Pharmaceutical care
Primary care
Drug related problem
Patient safety