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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
Sponsor:
Information provided by (Responsible Party):
Hugo Lovheim, Umeå University

Tracking Information
First Submitted Date  ICMJE January 3, 2012
First Posted Date  ICMJE January 5, 2012
Results First Submitted Date  ICMJE October 27, 2017
Results First Posted Date  ICMJE November 9, 2021
Last Update Posted Date November 9, 2021
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2021)
Number of Patients Readmitted Because of Drug Related Reasons [ Time Frame: Six months follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
Frequency of drug related readmissions [ Time Frame: Six months follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2021)
  • 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.
  • Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group. [ Time Frame: Six months follow-up ]
  • Frequency of Emergency Department Visits During the 6-month Follow-up. [ Time Frame: Six months follow-up ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
  • 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 ]
  • Time until institutionalization after discharge compared between control group and intervention group. [ Time Frame: Six months follow-up ]
  • Frequency of hospital visits (readmissions and emergency department) during the 6-month follow-up. [ Time Frame: Six months follow-up ]
  • Time from discharge to readmission [ Time Frame: Six months follow-up ]
  • Adherence to the quality indicators published by the Swedish National Board of Health and Welfare [ Time Frame: Six months follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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 Arms  ICMJE
  • Experimental: Medication review
    Intervention: Other: Medication review
  • No Intervention: Usual care
Publications * Gustafsson M, Sjölander M, Pfister B, Jonsson J, Schneede J, Lövheim H. Pharmacist participation in hospital ward teams and hospital readmission rates among people with dementia: a randomized controlled trial. Eur J Clin Pharmacol. 2017 Jul;73(7):827-835. doi: 10.1007/s00228-017-2249-8. Epub 2017 Apr 8.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2012)
460
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date June 2015   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01504672
Other Study ID Numbers  ICMJE UmU-2011-148-31M
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hugo Lovheim, Umeå University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Umeå University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hugo Lövheim, MD, PhD Umeå University, Umeå, Sweden
PRS Account Umeå University
Verification Date October 2021

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