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Multidrug Blister Pack Study

This study is currently recruiting participants.
Verified March 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
Kurt Hersberger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01759095
First received: November 2, 2012
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Any Event Leading to Hospitalisation
 Device: Electronic multidrug blister pack

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Time to rehospitalisation + time to major therapy adjustment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The outcome measure will be assessed at 3, 6, and 12 months.

  • Medication Possession Ratio [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    MPR will be assessed at 3, 6, and 12 months.


Secondary Outcome Measures:
  • Timing and taking adherence according to the electronic monitoring system and through patient self report [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Electronic monitoring will be continuous over 12 months. Patient self report will be assessed at 3, 6, and 12 months.

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quality of life will be assessed at 3, 6, and 12 months.

  • Patient satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759095

Contacts
Contact: Fabienne J Boeni, MSc Pharm 0041612671529 fabienne.boeni@unibas.ch
Contact: Isabelle Arnet, MSc Pharm / PhD 0041612671567 isabelle.arnet@unibas.ch

Locations
Switzerland
Notfallapotheke Recruiting
Basel, Basel-Stadt, Switzerland, 4056
Contact: Fabienne J Boeni, MSc Pharm     0041612671529     fabienne.boeni@unibas.ch    
Principal Investigator: Fabienne J Boeni, MSc Pharm            
Sub-Investigator: Isabelle Arnet, MSc Pharm, PhD            
Sub-Investigator: Samuel Allemann, MSc Pharm            
Sub-Investigator: Esther Spinatsch, MSc Pharm            
Sponsors and Collaborators
Kurt Hersberger
Investigators
Study Chair: Kurt E Hersberger, Prof PhD University of Basel
  More Information

Additional Information:
Pharmaceutical Care Research Group, University of Basel, Switzerland  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Kurt Hersberger, Professor PhD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01759095     History of Changes
Other Study ID Numbers: EKBB54/12
Study First Received: November 2, 2012
Last Updated: March 19, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
adherence
electronic monitoring
primary care
 community pharmacy
multidrug blister pack
pill box

Additional relevant MeSH terms:
Blister
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013