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Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication

Primary Purpose

Elderly, Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pharmacist intervention
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly focused on measuring Adverse drug reaction, Inappropriate medication, Pharmacist, Pharmaceutical care

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shin Kong Wo Ho-Su Memorial Hospital, Department of Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharmacist intervention

Usual care

Arm Description

Patients in the intervention group will receive pharmaceutical care delivered by clinical pharmacist, which including medication review, medication reconciliation, patient education and recommended actions.

Patients randomized to usual care group will receive routine review of medication by ward-based pharmacist and nurse.

Outcomes

Primary Outcome Measures

Number of unsolved drug-related problems

Secondary Outcome Measures

Rate of adverse drug event during hospitalization
Number of potentially inappropriate medication

Full Information

First Posted
February 12, 2009
Last Updated
March 30, 2009
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00844025
Brief Title
Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication
Official Title
Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication: a Randomized-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Chronic Disease
Keywords
Adverse drug reaction, Inappropriate medication, Pharmacist, Pharmaceutical care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist intervention
Arm Type
Experimental
Arm Description
Patients in the intervention group will receive pharmaceutical care delivered by clinical pharmacist, which including medication review, medication reconciliation, patient education and recommended actions.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients randomized to usual care group will receive routine review of medication by ward-based pharmacist and nurse.
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist intervention
Intervention Description
Medication review, medication reconciliation, and pharmacotherapy recommendation.
Primary Outcome Measure Information:
Title
Number of unsolved drug-related problems
Time Frame
14 days after randomization
Secondary Outcome Measure Information:
Title
Rate of adverse drug event during hospitalization
Time Frame
14 days after randomization
Title
Number of potentially inappropriate medication
Time Frame
14 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Jen Wei, MS
Organizational Affiliation
Shin Kong Wo Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wo Ho-Su Memorial Hospital, Department of Pharmacy
City
Taipei
ZIP/Postal Code
111
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
14662625
Citation
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.
Results Reference
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PubMed Identifier
18829684
Citation
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.
Results Reference
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PubMed Identifier
11443021
Citation
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.
Results Reference
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PubMed Identifier
17554532
Citation
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.
Results Reference
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Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication

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