Polymedication Check - a Randomised Controlled Trial (evalPMC)

Kurt Hersberger

Status: Completed

Conditions: Polypharmacy

Treatments: Behavioral: Medication review

Study type: Interventional

Funder types: Other

Identifiers

NCT01739816

evalPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

450 participants in 3 patient groups

Control group

No Intervention group

Description:

Patients get no intervention at study start, but only at study end after seven months.

Intervention group

Active Comparator group

Description:

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).

Treatment:

Behavioral: Medication review

Observational arm

Other group

Description:

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.

Treatment:

Behavioral: Medication review