Multidrug Blister Pack Study

April 8, 2015 updated by: Kurt Hersberger

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
        • Notfallapotheke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
At hospital discharge, patients of the control group will receive usual care at their community pharmacy.
EXPERIMENTAL: Electronic Multidrug Blister Pack
Device: Electronic multidrug blister pack
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.
Other Names:
  • Multidrug blister pack: Pharmis GmbH, Beinwil am See, Switzerland
  • Electronic film: Confrérie Clinique S.A., Lausanne, Switzerland

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kurt Hersberger

Investigators

  • Study Chair: Kurt E Hersberger, Prof PhD, University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

December 23, 2012

First Posted (ESTIMATE)

January 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKBB54/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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