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

Primary Purpose

Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Medication review
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Impairment focused on measuring Drug related problems

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • County hospital of Skellefteå
  • Umeå University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medication review

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients Readmitted Because of Drug Related Reasons

Secondary Outcome Measures

Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group.
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.
Frequency of Emergency Department Visits During the 6-month 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
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.

Full Information

First Posted
January 3, 2012
Last Updated
October 11, 2021
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01504672
Brief Title
An Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia
Official Title
A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
Drug related problems

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication review
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Medication review
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Patients Readmitted Because of Drug Related Reasons
Time Frame
Six months follow-up
Secondary Outcome Measure Information:
Title
Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group.
Description
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.
Time Frame
Six months follow-up
Title
Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.
Time Frame
Six months follow-up
Title
Frequency of Emergency Department Visits During the 6-month Follow-up.
Time Frame
Six months follow-up
Title
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
Description
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.
Time Frame
Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Lövheim, MD, PhD
Organizational Affiliation
Umeå University, Umeå, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
County hospital of Skellefteå
City
Skellefteå
ZIP/Postal Code
931 86
Country
Sweden
Facility Name
Umeå University Hospital
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28391409
Citation
Gustafsson M, Sjolander M, Pfister B, Jonsson J, Schneede J, Lovheim 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.
Results Reference
derived

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

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