Multidrug Blister Pack Study

Not Applicable

Terminated

• Conditions: Any Event Leading to Hospitalisation
• Interventions: Device: Electronic multidrug blister pack

• Registration Number: NCT01759095
• Lead Sponsor: Kurt Hersberger

Brief Summary

The purpose of this study is to determine the benefit of patients using a multidrug blister packs after discharged from an university hospital to their homes.

Detailed Description

Typical adherence rates for oral prescription medications are approximately 50-76%. Insufficient adherence causes an increase in morbidity, mortality, and costs, and decreases quality of life of patients. Multidrug blister packs are recommended to improve adherence and are widely used in Switzerland. However, evidence is poor and patient-relevant endpoints are seldom measured. This study was designed to compare patient-relevant outcomes in patients with medication repackaged in multidrug blister packs versus patients with medication dispensed in commercially available packages. Adherence of the intervention group will be monitored electronically and feedback will be given to the patients. The intervention will take place in a study pharmacy. Follow-up visits will take place at the study pharmacy at 3, 6, and 12 months for all patients. Study duration will be 12 months.

Study Timeline

• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-12-23
• Study Start: 2013-01
• Study First Posted: 2013-01-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Age over 18 years
• Prescription of 4 or more different oral solid drugs
• Capable to understand german (verbally and written)
• Capable to give informed consent
• Insured by a Swiss health insurance
• Manages his/her pharmacotherapy without external support
• Obtains his/her medication from a community pharmacy
• Accepts to use an electronic multidrug blister pack
• Place of domicile in Basel-Stadt or Basel-Land

Exclusion Criteria

• Pregnancy
• > 2 drugs that cannot be packed into a multidrug blister pack (e.g. fluids)
• Dementia, or evaluated as cognitively impaired by the responsible nurse
• Transplanted patient
• Anticoagulation with oral vitamin K antagonists
• Has already used a multidrug blister pack of Pharmis or a Medifilm® single dose system
• is visually impaired (blind)
• cannot push drugs through a blister
• refuses to allow contact to his/her regular pharmacy and GP
• is referred to a nursing home or to rehabilitation or another hospital at discharge
• is included in other clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic Multidrug Blister Pack	Electronic multidrug blister pack	-

Primary Outcome Measures

Name	Time	Method
Medication Possession Ratio	12 months	MPR will be assessed at 3, 6, and 12 months.
Time to rehospitalisation + time to major therapy adjustment	12 months	The outcome measure will be assessed at 3, 6, and 12 months.

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 months	Quality of life will be assessed at 3, 6, and 12 months.
Timing and taking adherence according to the electronic monitoring system and through patient self report	12 months	Electronic monitoring will be continuous over 12 months. Patient self report will be assessed at 3, 6, and 12 months.
Patient satisfaction	12 months

Trial Locations

Locations (1)

Notfallapotheke; 🇨🇭 Basel, Basel-Stadt, Switzerland