Optimizing Drug-Therapy in Patients 80 Years and Older | NCT00661310

Studies
Optimizing Drug-Therapy in Patients 80 Years and Older

NCT00661310

Sponsor

Uppsala University Hospital

Status

Completed

Last Update Posted

Dec 5, 2008Estimated

Enrollment

400Actual

Phase

Not Applicable

Conditions

Drug-Related Problems

Interventions

Drug review 80+ -To reduce usage of hospital care

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2007Actual

First Submitted Date

Apr 14, 2008

First Submission Date that Met QC Criteria

Apr 17, 2008

First Posted Date

Apr 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2008

Last Update Posted Date

Dec 5, 2008Estimated

Name	Class
Uppsala University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to measure the effects of an enhanced service where a pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and transferring information between primary and secondary care). Primary outcome measure is visits to hospital during a 12-month follow-up period, and the population is patients 80 years and older.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental	Intervention by team consisting of Doctor, pharmacist and nurse	Other: Drug review 80+ -To reduce usage of hospital care
C	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug review 80+ -To reduce usage of hospital care	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects on hospital visits		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

80 years and older
Acute admission to study ward

Exclusion Criteria:

<80 years
Scheduled admission
Previously admitted to studyward during study period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Toss, MD PhD	Uppsala University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University hospital		Uppsala		75185	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19433702	Derived	Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.