AzTrials
AzTrials

PolypharmacyevalPMCNCT01739816

Polymedication Check - a Randomised Controlled Trial

A study testing Medication review in people with Polypharmacy, run by Kurt Hersberger at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Polypharmacy
What is being tested?
Medication review
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteSwitzerland
Study dates
Jun 2012to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Pharmaceutical Care Research Group, University of Basel

    Basel, Basel, 4056

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Conditions
Polypharmacy
Being tested
Medication review
Keywords
Compliance, Adherence, Polypharmacy, Medicines use, Medication review, Pharmaceutical care, Primary care, Drug related problem, Patient safety
Medical subject headings
Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication reviewBehavioural

    Also called Polymedication Check

    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.

Study groups in NCT01739816
Study groupRoleWhat they receive
Control groupNo interventionPatients get no intervention at study start, but only at study end after seven months.
Intervention groupActive comparatorAt 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).
Receives: Behavioral: Medication review
Observational armOtherIf 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.
Receives: Behavioral: Medication review

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Seven months after recruitment

Secondary outcomes (4)

  1. Time to planned or unplanned consulting with a physician or hospitalisation

    Time to planned or unplanned consulting with a physician or hospitalisation

    Measured: Seven months after recruitment

  2. Patient knowledge about his medicines

    Patient knowledge about his medicines use, assessed through PMC (intervention goup) and two telephone interviews (both groups)

    Measured: After two weeks, four and seven months after recruitment

  3. Self reported adherence

    Self report of adherence: is assessed with self administrated questionnaires and telephone interviews

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

  4. Patients safety

    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.

    Measured: After two weeks, four and seven months after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionFeb 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01739816
Sponsor's protocol ID
evalPMC
Acronym
evalPMC
Status last verified
Apr 2014
First submitted
27 Nov 2012
Last updated
9 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22486599

  • 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.

    PubMed 17922887

  • 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.

    PubMed 17004019

  • 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.

    PubMed 21428465

  • 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.

    PubMed 21385240

  • 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.

    PubMed 27108410

Questions about this trial

What is this clinical trial studying?

A study testing Medication review in people with Polypharmacy, run by Kurt Hersberger at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication possession ratio (MPR), gaps and persistence in medicines use (time frame: Seven months after recruitment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01739816, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in