NCT01504672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

November 9, 2021

Completed
Last Updated

November 9, 2021

Status Verified

October 1, 2021

Enrollment Period

3.4 years

First QC Date

January 3, 2012

Results QC Date

October 27, 2017

Last Update Submit

October 11, 2021

Conditions

Cognitive Impairment

Keywords

Drug related problems

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Readmitted Because of Drug Related Reasons

    Six months follow-up

Secondary Outcomes (4)

  • Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group.

    Six months follow-up

  • Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.

    Six months follow-up

  • Frequency of Emergency Department Visits During the 6-month Follow-up.

    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

    Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7)

Study Arms (2)

Medication review

EXPERIMENTAL
Other: Medication review

Usual care

NO INTERVENTION

Interventions

Medication reviewOTHER

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

Medication review

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

County hospital of Skellefteå

Skellefteå, 931 86, Sweden

Location

Umeå University Hospital

Umeå, 901 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 28391409DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Results Point of Contact

Title
Dr. Maria Gustafsson
Organization
Umeå University
maria.gustafsson@umu.se
0046703978717

Study Officials

  • Hugo Lövheim, MD, PhD

    Umeå University, Umeå, Sweden

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 5, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

November 9, 2021

Results First Posted

November 9, 2021

Record last verified: 2021-10

Locations

SE(2)