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An Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01504672
Recruitment Status : Completed
First Posted : January 5, 2012
Results First Posted : November 9, 2021
Last Update Posted : November 9, 2021
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 Phase
Cognitive Impairment Other: Medication review Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Medicines

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. Number of Patients Readmitted Because of Drug Related Reasons [ 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 ]
    To evaluate the economic impact of clinical pharmacist engagement in hospital ward teams for medication therapy management in older patients with dementia or cognitive impairments.

  2. Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group. [ Time Frame: Six months follow-up ]
  3. Frequency of Emergency Department Visits During the 6-month Follow-up. [ Time Frame: Six months follow-up ]
  4. Change in the Number of Participants With Potentially Inappropriate Medications, According to the Swedish National Board of Health and Welfare, at Admission and Discharge Between Intervention and Control Group [ Time Frame: Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7) ]
    Six drug-specific quality indicators as defined by the Swedish National Board of Health and Welfare were used to define use of Potentially inappropriate medications (PIMs) in this study. Four out of the six selected indicators belong to a group where drug-use should be as low as possible regardless of indication: anticholinergic drugs (as defined by the Swedish National Board of Health and Welfare, propiomazine, tramadol, and long-acting benzodiazepines. The two remaining indicators are classified as preparations for which correct and current indication is of particular importance: antipsychotic drugs (N05A except lithium) and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). In the present study, a PIM was defined as exposure to at least one of the drugs mentioned among the six quality indicators.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
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

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County hospital of Skellefteå
Skellefteå, Sweden, 931 86
Umeå University Hospital
Umeå, Sweden, 901 85
Sponsors and Collaborators
Umeå University
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Principal Investigator: Hugo Lövheim, MD, PhD Umeå University, Umeå, Sweden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hugo Lovheim, Principal Investigator, Umeå University
ClinicalTrials.gov Identifier: NCT01504672    
Other Study ID Numbers: UmU-2011-148-31M
First Posted: January 5, 2012    Key Record Dates
Results First Posted: November 9, 2021
Last Update Posted: November 9, 2021
Last Verified: October 2021
Keywords provided by Hugo Lovheim, Umeå University:
Drug related problems
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders