Clinical trial NCT01504672: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: Drug related problems
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 460
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Number of Patients Readmitted Because of Drug Related Reasons
timeFrame: Six months follow-up
Secondary outcomes:
measure: Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group.
timeFrame: Six months follow-up
measure: Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.
timeFrame: Six months follow-up
measure: Frequency of Emergency Department Visits During the 6-month Follow-up.
timeFrame: Six months follow-up
measure: 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
timeFrame: Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7)
Other outcomes:
Locations:
city: Skellefteå
country: Sweden
facility: County hospital of Skellefteå
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University, Umeå, Sweden
name: Hugo Lövheim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.