Clinical trial NCT01759095: Multidrug Blister Pack Study
Official title: Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Any Event Leading to Hospitalisation
Keywords: adherence
electronic monitoring
primary care
community pharmacy
multidrug blister pack
pill box
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-01-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Time to rehospitalisation + time to major therapy adjustment
timeFrame: 12 months
measure: Medication Possession Ratio
timeFrame: 12 months
Secondary outcomes:
measure: Timing and taking adherence according to the electronic monitoring system and through patient self report
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Notfallapotheke
state: Basel-Stadt
Study officials:
affiliation: University of Basel
name: Kurt E Hersberger, Prof PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.