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

Cognitive Impairment Clinical Trial

Official title:

A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504672
• Other study ID #: UmU-2011-148-31M
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: August 2015

Study information

• Verified date: October 2021
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Dementia

Intervention

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

Locations

Country	Name	City	State
Sweden	County hospital of Skellefteå	Skellefteå
Sweden	Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Readmitted Because of Drug Related Reasons		Six months follow-up
Secondary	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.	Six months follow-up
Secondary	Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.		Six months follow-up
Secondary	Frequency of Emergency Department Visits During the 6-month Follow-up.		Six months follow-up
Secondary	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.	Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7)