NCT00844025

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

February 12, 2009

Last Update Submit

March 30, 2009

Conditions

ElderlyChronic Disease

Keywords

Adverse drug reactionInappropriate medicationPharmacistPharmaceutical care

Outcome Measures

Primary Outcomes (1)

  • Number of unsolved drug-related problems

    14 days after randomization

Secondary Outcomes (2)

  • Rate of adverse drug event during hospitalization

    14 days after randomization

  • Number of potentially inappropriate medication

    14 days after randomization

Study Arms (2)

Pharmacist intervention

EXPERIMENTAL

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

Behavioral: Pharmacist intervention

Usual care

NO INTERVENTION

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

Interventions

Pharmacist interventionBEHAVIORAL

Medication review, medication reconciliation, and pharmacotherapy recommendation.

Pharmacist intervention

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Hospitalized patients aged at least 65 years
  • Taking at least six prescribed medicines regularly, including at least one potential inappropriate medication

You may not qualify if:

  • Patients who refused informed consent
  • Discharged before consent could be obtained
  • Cognitive impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, 111, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 14662625BACKGROUND

  • 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.

    PMID: 18829684BACKGROUND

  • 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.

    PMID: 11443021BACKGROUND

  • 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.

    PMID: 17554532BACKGROUND

MeSH Terms

Conditions

Chronic DiseaseDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced Disorders

Study Officials

  • Liu Jen Wei, MS

    Shin Kong Wo Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

TW(1)