Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication
March 30, 2009 updated by: Shin Kong Wu Ho-Su Memorial Hospital
Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication: a Randomized-Controlled Trial
The investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
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
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Taipei, Taiwan, 111
- Shin Kong Wo Ho-Su Memorial Hospital, Department of Pharmacy
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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
65 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hospitalized patients aged at least 65 years
- Taking at least six prescribed medicines regularly, including at least one potential inappropriate medication
Exclusion Criteria:
- Patients who refused informed consent
- Discharged before consent could be obtained
- Cognitive impaired
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pharmacist intervention
Patients in the intervention group will receive pharmaceutical care delivered by clinical pharmacist, which including medication review, medication reconciliation, patient education and recommended actions.
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Medication review, medication reconciliation, and pharmacotherapy recommendation.
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No Intervention: Usual care
Patients randomized to usual care group will receive routine review of medication by ward-based pharmacist and nurse.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of unsolved drug-related problems
Time Frame: 14 days after randomization
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14 days after randomization
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Rate of adverse drug event during hospitalization
Time Frame: 14 days after randomization
|
14 days after randomization
|
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Number of potentially inappropriate medication
Time Frame: 14 days after randomization
|
14 days after randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Liu Jen Wei, MS, Shin Kong Wo Ho-Su Memorial Hospital
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
- Gallagher P, O'Mahony D. STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions): application to acutely ill elderly patients and comparison with Beers' criteria. Age Ageing. 2008 Nov;37(6):673-9. doi: 10.1093/ageing/afn197. Epub 2008 Oct 1.
- Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003 Dec 8-22;163(22):2716-24. doi: 10.1001/archinte.163.22.2716. Erratum In: Arch Intern Med. 2004 Feb 9;164(3):298.
- Krska J, Cromarty JA, Arris F, Jamieson D, Hansford D, Duffus PR, Downie G, Seymour DG. Pharmacist-led medication review in patients over 65: a randomized, controlled trial in primary care. Age Ageing. 2001 May;30(3):205-11. doi: 10.1093/ageing/30.3.205.
- Laroche ML, Charmes JP, Merle L. Potentially inappropriate medications in the elderly: a French consensus panel list. Eur J Clin Pharmacol. 2007 Aug;63(8):725-31. doi: 10.1007/s00228-007-0324-2. Epub 2007 Jun 7.
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
February 1, 2009
Primary Completion (Anticipated)
February 1, 2010
Study Completion (Anticipated)
February 1, 2010
Study Registration Dates
First Submitted
February 12, 2009
First Submitted That Met QC Criteria
February 12, 2009
First Posted (Estimate)
February 13, 2009
Study Record Updates
Last Update Posted (Estimate)
March 31, 2009
Last Update Submitted That Met QC Criteria
March 30, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKH-8302-98-NDR-05
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.