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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
  Purpose

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.


Condition Intervention
Cognitive Impairment
 Other: Medication review

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

Resource links provided by NLM:

MedlinePlus related topics: Dementia
U.S. FDA Resources

Further study details as provided by Umeå University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 460
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medication review 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
No Intervention: Usual care

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with dementia or cognitive impairment
  • Patients ≥ 65 years

Exclusion Criteria:

  • Patients previously admitted to the study wards during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504672

Contacts
Contact: Hugo Lövheim, MD, PhD 0046702979499 hugo.lovheim@germed.umu.se

Locations
Sweden
County hospital of Skellefteå Recruiting
Skellefteå, Sweden, 931 86
Contact: Hugo Lövheim, PhD     0046702979499     hugo.lovheim@germed.umu.se    
Contact: Jeanette Jonsson     0046910-71 62 07     jeanette.jonsson@vll.se    
Principal Investigator: Hugo Lövheim, MD, PhD            
Sub-Investigator: Maria Gustafsson            
Umeå University Hospital Recruiting
Umeå, Sweden, 901 85
Contact: Hugo Lövheim, PhD     0046702979499     hugo.lovheim@germed.umu.se    
Contact: Maria Gustafsson     00467853562     maria.gustafsson@pharm.umu.se    
Principal Investigator: Hugo Lövheim, MD, PhD            
Sub-Investigator: Maria Gustafsson            
Sponsors and Collaborators
Umeå University
  More Information

No publications provided

Responsible Party: Hugo Lovheim, Principal Investigator, Umeå University
ClinicalTrials.gov Identifier: NCT01504672     History of Changes
Other Study ID Numbers: UmU-2011-148-31M
Study First Received: January 3, 2012
Last Updated: January 16, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Drug related problems

Additional relevant MeSH terms:
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013