An 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
Results First Posted : November 9, 2021
Last Update Posted : November 9, 2021
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||460 participants|
|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|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||August 2015|
|Experimental: Medication review||
Other: Medication review
In the intervention, the pharmacist will evaluate:
|No Intervention: Usual care|
- Number of Patients Readmitted Because of Drug Related Reasons [ Time Frame: Six months follow-up ]
- 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.
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|
|Principal Investigator:||Hugo Lövheim, MD, PhD||Umeå University, Umeå, Sweden|