A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

This study is currently recruiting participants.

Verified January 2012 by Umeå University

Sponsor:

Information provided by (Responsible Party):

Hugo Lovheim, Umeå University

ClinicalTrials.gov Identifier:

NCT01504672

First received: January 3, 2012

Last updated: January 16, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 3, 2012

Last Updated Date

January 16, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of drug related readmissions [ Time Frame: Six months follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01504672 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cost for visits for readmissions and to the Emergency Department compared between patients in the control group and intervention group. [ Time Frame: Six months follow-up ] [ Designated as safety issue: No ]
Time until institutionalization after discharge compared between control group and intervention group. [ Time Frame: Six months follow-up ] [ Designated as safety issue: No ]
Frequency of hospital visits (readmissions and emergency department) during the 6-month follow-up. [ Time Frame: Six months follow-up ] [ Designated as safety issue: No ]
Time from discharge to readmission [ Time Frame: Six months follow-up ] [ Designated as safety issue: No ]
Adherence to the quality indicators published by the Swedish National Board of Health and Welfare [ Time Frame: Six months follow-up ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

Official Title ^ICMJE

A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

Brief Summary

The aim of this randomized controlled study is to investigate if medication reviews performed by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive failure.

Four hundred and sixty patients will be recruited and randomized to control (usual care) and intervention group (enhanced service in which a pharmacist is part of the health care team).

Six months after the last patient of the 460 has been discharged the study will be closed. Data about the number of readmissions and visits to the emergency room will be collected during the six-month follow-up and also, the costs associated with each visit or admission. Time until institutionalization will be compared between intervention group and control group.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)

Condition ^ICMJE

Cognitive Impairment

Intervention ^ICMJE

Other: Medication review

In the intervention, the pharmacist will evaluate:

Is there an indication for the drug?
Has the drug desired effect?
Is the dose correct and dosing scheme correct?
Side effects, contraindications, inappropriate drugs
Interactions
Treatment time
Cost effectiveness
Adherence to recommendation list
Problems with handling the drugs (for example crushing of the tablets)
Untreated indication
Double medications
Administration of drugs

Study Arm (s)

Experimental: Medication review
Intervention: Other: Medication review
No Intervention: Usual care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

460

Estimated Completion Date

December 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with dementia or cognitive impairment
Patients ≥ 65 years

Exclusion Criteria:

Patients previously admitted to the study wards during the study period

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hugo Lövheim, MD, PhD

0046702979499

hugo.lovheim@germed.umu.se

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01504672

Other Study ID Numbers ^ICMJE

UmU-2011-148-31M

Has Data Monitoring Committee

Not Provided

Responsible Party

Hugo Lovheim, Umeå University

Study Sponsor ^ICMJE

Umeå University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Umeå University

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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