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Multidrug Blister Pack Study

Primary Purpose

Any Event Leading to Hospitalisation

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Electronic multidrug blister pack
Sponsored by
Kurt Hersberger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Any Event Leading to Hospitalisation focused on measuring adherence, electronic monitoring, primary care, community pharmacy, multidrug blister pack, pill box

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Notfallapotheke

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Electronic Multidrug Blister Pack

Arm Description

At hospital discharge, patients of the control group will receive usual care at their community pharmacy.

Outcomes

Primary Outcome Measures

Time to rehospitalisation + time to major therapy adjustment
The outcome measure will be assessed at 3, 6, and 12 months.
Medication Possession Ratio
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
Electronic monitoring will be continuous over 12 months. Patient self report will be assessed at 3, 6, and 12 months.
Quality of life
Quality of life will be assessed at 3, 6, and 12 months.
Patient satisfaction

Full Information

First Posted
November 2, 2012
Last Updated
April 8, 2015
Sponsor
Kurt Hersberger
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1. Study Identification

Unique Protocol Identification Number
NCT01759095
Brief Title
Multidrug Blister Pack Study
Official Title
Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Difficulties with patient recruitement
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kurt Hersberger

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Any Event Leading to Hospitalisation
Keywords
adherence, electronic monitoring, primary care, community pharmacy, multidrug blister pack, pill box

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
At hospital discharge, patients of the control group will receive usual care at their community pharmacy.
Arm Title
Electronic Multidrug Blister Pack
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electronic multidrug blister pack
Other Intervention Name(s)
Multidrug blister pack: Pharmis GmbH, Beinwil am See, Switzerland, Electronic film: Confrérie Clinique S.A., Lausanne, Switzerland
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to rehospitalisation + time to major therapy adjustment
Description
The outcome measure will be assessed at 3, 6, and 12 months.
Time Frame
12 months
Title
Medication Possession Ratio
Description
MPR will be assessed at 3, 6, and 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Timing and taking adherence according to the electronic monitoring system and through patient self report
Description
Electronic monitoring will be continuous over 12 months. Patient self report will be assessed at 3, 6, and 12 months.
Time Frame
12 months
Title
Quality of life
Description
Quality of life will be assessed at 3, 6, and 12 months.
Time Frame
12 months
Title
Patient satisfaction
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt E Hersberger, Prof PhD
Organizational Affiliation
University of Basel
Official's Role
Study Chair
Facility Information:
Facility Name
Notfallapotheke
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4056
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21901694
Citation
Mahtani KR, Heneghan CJ, Glasziou PP, Perera R. Reminder packaging for improving adherence to self-administered long-term medications. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD005025. doi: 10.1002/14651858.CD005025.pub3.
Results Reference
background
PubMed Identifier
9467683
Citation
Cramer JA. Enhancing patient compliance in the elderly. Role of packaging aids and monitoring. Drugs Aging. 1998 Jan;12(1):7-15. doi: 10.2165/00002512-199812010-00002.
Results Reference
background
PubMed Identifier
16079372
Citation
Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
Results Reference
background
PubMed Identifier
14998735
Citation
Rosen MI, Rigsby MO, Salahi JT, Ryan CE, Cramer JA. Electronic monitoring and counseling to improve medication adherence. Behav Res Ther. 2004 Apr;42(4):409-22. doi: 10.1016/S0005-7967(03)00149-9.
Results Reference
background
Links:
URL
http://www.pharmacare.unibas.ch
Description
Pharmaceutical Care Research Group, University of Basel, Switzerland

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Multidrug Blister Pack Study

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