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

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ClinicalTrials.gov Identifier: NCT01504672
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Hugo Lovheim, Umeå University

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.

Condition or disease Intervention/treatment
Cognitive Impairment Other: Medication review

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia
Study Start Date : January 2012
Primary Completion Date : June 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Frequency of drug related readmissions [ Time Frame: Six months follow-up ]

Secondary Outcome Measures :
  1. 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 ]
  2. Time until institutionalization after discharge compared between control group and intervention group. [ Time Frame: Six months follow-up ]
  3. Frequency of hospital visits (readmissions and emergency department) during the 6-month follow-up. [ Time Frame: Six months follow-up ]
  4. Time from discharge to readmission [ Time Frame: Six months follow-up ]
  5. Adherence to the quality indicators published by the Swedish National Board of Health and Welfare [ Time Frame: Six months follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients previously admitted to the study wards during the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504672

County hospital of Skellefteå
Skellefteå, Sweden, 931 86
Umeå University Hospital
Umeå, Sweden, 901 85
Sponsors and Collaborators
Umeå University
Principal Investigator: Hugo Lövheim, MD, PhD Umeå University, Umeå, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hugo Lovheim, Principal Investigator, Umeå University
ClinicalTrials.gov Identifier: NCT01504672     History of Changes
Other Study ID Numbers: UmU-2011-148-31M
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Hugo Lovheim, Umeå University:
Drug related problems

Additional relevant MeSH terms:
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders