- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00661310
Optimizing Drug-Therapy in Patients 80 Years and Older
Optimizing Drug-Therapy in Patients, 80 Years and Older, in Order to Reduce Drug-Related Morbidity and Usage of Secondary Care - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Optimising drug-therapy for patients, 80 years and older, to reduce hospital visits
Background and Objective:
Results from a pilot-study performed in 2004 at the Academic Hospital, Uppsala, including 214 consecutive patients (80 years old or older) showed that 9.4%-13.6% of the patients were acutely admitted to hospital due to a drug related problem1. Other similar international studies show that the frequency of drug-related hospital admissions stands for at least 14% of the acute admissions (14%-30.4%). Of these admissions it was estimated that 32%-69% were preventable 2,3,4.
A study from Antrim Hospital, Northern Ireland, showed that pharmacists´ involvement in the health care team can reduce the number of acute hospital admissions and improve quality of drug use5.
In view of these findings this study was initiated in 2005 with fundings from the Drug and Therapeutics committee, the County Council of Uppsala, the Division of Acute-Medicine and the Pharmacy Department at the Academic Hospital in Uppsala
Aim and objectives:
The Study Aim was to optimize drug-prescribing and drug use for patients 80 years and older.
The main objective was to reduce the number of hospital visits for patients 80-years old or older.
Design:
A randomized, controlled trial including 400 patients (200+200). Patients in the intervention group (I) received a patient interview on admission, drug counseling on discharge and a drug review - all performed by a clinical pharmacist. Patients in the control group (C) received standard care, without pharmacists´ involvement.
Patients were included between Oct 2005 and June 2006.
Setting:
Two wards at the Division of Acute-Medicine at Uppsala University Hospital, Sweden
Main Outcome Measures:
1) Frequency of hospital visits 12 months after (last included patient) discharge from hospital for (I) and (C).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Uppsala, Sweden, 75185
- Uppsala University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 80 years and older
- Acute admission to study ward
Exclusion Criteria:
- <80 years
- Scheduled admission
- Previously admitted to studyward during study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: C
|
|
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Experimental: I
Intervention by team consisting of Doctor, pharmacist and nurse
|
drug review performed by multiprofessional team, including clinical pharmacist, in order to optimize drug therapy and reduce usage of hospital care.
Also patient education and follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Effects on hospital visits
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Henrik Toss, MD PhD, Uppsala University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Uppsala80
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