Polymedication Check - a Randomised Controlled Trial

Polypharmacy Clinical Trial

— evalPMC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739816
• Other study ID #: evalPMC
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: April 8, 2014
• Start date: June 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Polypharmacy

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Pharmaceutical Care Research Group, University of Basel	Basel

Sponsors (5)

Lead Sponsor	Collaborator
Kurt Hersberger	Polyclinique Médicale Universitaire, PMU, Lausanne, Swiss Pharmacy Association, pharmaSuisse, University Hospital, Basel, Switzerland, University of Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. Epub 2006 Sep 27. — View Citation

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. Epub 2007 Oct 8. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of compliance aids	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	No
Primary	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	No
Secondary	Time to planned or unplanned consulting with a physician or hospitalisation	Time to planned or unplanned consulting with a physician or hospitalisation	Seven months after recruitment	No
Secondary	Patient knowledge about his medicines	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	No
Secondary	Self reported adherence	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	No
Secondary	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.	After two weeks, four and seven months after recruitment	Yes

External Links

•   For information concerning 'Medication Review'
•   For recent publications, see 'Publications' -> 'Publications' and 'Posters'