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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Cognitive Impairment
Intervention Other: Medication review
Enrollment 460
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

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
Usual Care where no medication review is performed by clinical pharmacists
Period Title: Overall Study
Started 230 230
Completed 212 217
Not Completed 18 13
Arm/Group Title Intervention Group Control Group Total
Hide Arm/Group Description An intervention as described is performed for the people in the intervention group. No intervention is performed. Total of all reporting groups
Overall Number of Baseline Participants 212 217 429
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 217 participants 429 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
212
 100.0%
217
 100.0%
429
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 212 participants 217 participants 429 participants
83.1  (6.6) 83.1  (6.6) 83.1  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 217 participants 429 participants
Female
133
  62.7%
138
  63.6%
271
  63.2%
Male
79
  37.3%
79
  36.4%
158
  36.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 212 participants 217 participants 429 participants
212 217 429
Medical history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 212 participants 217 participants 429 participants
Heart failure 72 54 126
Hypertension 116 105 221
Cardiac arrhythmia 62 58 120
Diabetes Mellitus 61 47 108
COPD 16 18 34
Malignant disease, past or present 27 20 47
Myocardial infarction 36 25 61
Stroke, past 50 46 96
1.Primary Outcome
Title Number of Patients Readmitted Because of Drug Related Reasons
Hide Description [Not Specified]
Time Frame Six months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

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
Usual Care where no medication review is performed by clinical pharmacists
Overall Number of Participants Analyzed 212 217
Measure Type: Number
Unit of Measure: Participants
40 50
2.Secondary Outcome
Title Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medication Review Usual Care
Hide Arm/Group Description:

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
[Not Specified]
Overall Number of Participants Analyzed 212 217
Mean (Standard Deviation)
Unit of Measure: Euro
2340  (0) 2630  (0)
3.Secondary Outcome
Title Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.
Hide Description [Not Specified]
Time Frame Six months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 460 people included in this study, 31 deceased before discharge. Of the remaining 429 persons, 146+158=304 persons lived at home, and these were included in the analysis. The remaining 125 were already living in nursing homes and were not included in the analysis.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

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
Usual Care where no medication review is performed by clinical pharmacists
Overall Number of Participants Analyzed 146 158
Measure Type: Count of Participants
Unit of Measure: Participants
17
  11.6%
24
  15.2%
4.Secondary Outcome
Title Frequency of Emergency Department Visits During the 6-month Follow-up.
Hide Description [Not Specified]
Time Frame Six months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

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
Usual Care where no medication review is performed by clinical pharmacists
Overall Number of Participants Analyzed 212 217
Measure Type: Number
Unit of Measure: All-cause emergency department visits
190 184
5.Secondary Outcome
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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

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
Usual Care where no medication review is performed by clinical pharmacists
Overall Number of Participants Analyzed 212 217
Measure Type: Count of Participants
Unit of Measure: Participants
13
   6.1%
5
   2.3%
6.Post-Hoc Outcome
Title Time From Discharge to Drug-related Readmission
Hide Description Time from discharge to drug-related readmission among the whole sample, post-hoc
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medication Review Usual Care
Hide Arm/Group Description:

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
[Not Specified]
Overall Number of Participants Analyzed 212 217
Mean (Standard Deviation)
Unit of Measure: days
29.1  (0.30) 28.1  (0.43)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

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
Usual Care where no medication review is performed by clinical pharmacists
All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/212 (0.00%)   0/217 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/212 (0.00%)   0/217 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Maria Gustafsson
Organization: Umeå University
Phone: 0046703978717
EMail: maria.gustafsson@umu.se
Layout table for additonal information
Responsible Party: Hugo Lovheim, Umeå University
ClinicalTrials.gov Identifier: NCT01504672    
Other Study ID Numbers: UmU-2011-148-31M
First Submitted: January 3, 2012
First Posted: January 5, 2012
Results First Submitted: October 27, 2017
Results First Posted: November 9, 2021
Last Update Posted: November 9, 2021