Multidrug Blister Pack Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge

Conditions
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Any Event Leading to Hospitalisation

Intervention / Treatment
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* Device: Electronic multidrug blister pack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>At hospital discharge, patients of the control group will receive usual care at their community pharmacy. | |
| Experimental: Electronic Multidrug Blister Pack<br> | Device: Electronic multidrug blister pack<br>* At hospital discharge, patients will get their prescribed drugs repackaged in an electronic multidrug blister pack with 7x4 cavities. The electronic film affixed on the rear side measures the date and time when a loop is broken, i.e. when a cavity is emptied. Patients will get feedback on their adherence profiles at the community pharmacy.<br>* Other names: Electronic film: Confrérie Clinique S.A., Lausanne, Switzerland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to rehospitalisation + time to major therapy adjustment | The outcome measure will be assessed at 3, 6, and 12 months. | 12 months | 
| Medication Possession Ratio | MPR will be assessed at 3, 6, and 12 months. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, electronic monitoring, primary care, community pharmacy, multidrug blister pack, pill box