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Trial registered on ANZCTR


Registration number
ACTRN12611001078943
Ethics application status
Approved
Date submitted
14/10/2011
Date registered
18/10/2011
Date last updated
8/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing inappropriate medications in older institutionalized persons
Scientific title
Reducing inappropriate, anticholinergic and psychotropic medications in older institutionalized persons via staff training
Secondary ID [1] 273208 0
Nil
Universal Trial Number (UTN)
U1111-1125-2281
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inappropriate medication 278974 0
Condition category
Condition code
Other 279150 279150 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Public Health 279162 279162 0 0
Health promotion/education
Public Health 279163 279163 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The staff in intervention wards will be trained to identify inappropiate drugs, drugs with anticholinergic properties and psychotropic drugs in their patients as well as potentially dangerous drug-drug interactions. The training for the ward staff will take one day (6 hours). The training will be be on constructive and activating learning methods, the drugs problems will be discussed based on the patient cases in the ward. A responsible nurse will be pointed out in the ward to indentify problems in medication and to take them to the consulting doctor. The doctor will be responsible for changes in medication. The responsible nurse will get extra training (one session, 6 hours) on medications and their harmful effects. In addition, she will receive a list of inappropriate drugs. She will also receive tutoring for her work with the medications when needed.
Intervention code [1] 269544 0
Other interventions
Comparator / control treatment
No training. Normal care.
Control group
Active

Outcomes
Primary outcome [1] 279790 0
Number of inappropriate drugs (including those according to Beers' criteria, drugs with anticholinergic properties and psychotropic drugs)
Timepoint [1] 279790 0
6 and 12 months
Primary outcome [2] 279805 0
Number of potentially harmful drug-drug interactions (D-class according to SFINX)
Timepoint [2] 279805 0
6 and 12 months
Secondary outcome [1] 294432 0
Health-related quality-of life according to 15D-measure
Timepoint [1] 294432 0
6 and 12 months
Secondary outcome [2] 294433 0
Cognition according to clock-drawing test and verbal flow
Timepoint [2] 294433 0
6 and 12 months
Secondary outcome [3] 294434 0
Hospital admissions, use and costs of health services.
These will be assessed via medical records and central registers.
Timepoint [3] 294434 0
12 months

Eligibility
Key inclusion criteria
Living permanently in Helsinki nursing home/ assisted living facility
- 65 years+
- native Finnish skeaking
- uses at least one drug
- not at terminal stage (estimated prognosis >6 months)
- volunteer, participant or his/her proxy gives an informed consent to participate the study
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Terminal stage
Has no drugs in regular use

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
patients will be recruited by inviting them to participate. Their permission will be first acquired by informed consent. THereafter, the wards participating will be randomized into two categories: those receiving training concerning inappropriate drugs (intervention) and those continuing normal treatment without training (control)
Central randomisation by phone /fax /computer
Allocation will be concealed fromthe study nurses assessing participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3909 0
Finland
State/province [1] 3909 0

Funding & Sponsors
Funding source category [1] 270037 0
Hospital
Name [1] 270037 0
Helsinki University Central Hospital
Address [1] 270037 0
C/o Unit of General Practice
University of Helsinki
PO Box 20
00014 University of Helsinki
Country [1] 270037 0
Finland
Primary sponsor type
Hospital
Name
Helsinki University Central Hospital
Address
C/o Unit of General Practice
University of Helsinki
PO Box 20
00014 University of Helsinki
Country
Finland
Secondary sponsor category [1] 269008 0
None
Name [1] 269008 0
Address [1] 269008 0
Country [1] 269008 0
Other collaborator category [1] 252296 0
University
Name [1] 252296 0
University of Helsinki
Address [1] 252296 0
C/o Unit of General Practice
University of Helsinki
PO Box 20
00014 University of Helsinki
Country [1] 252296 0
Finland
Other collaborator category [2] 252297 0
Other Collaborative groups
Name [2] 252297 0
Helsinki City Social Services, Older people's Services
Address [2] 252297 0
c/o Helena Soini
PO BOX 7000
00099 Helsingin kaupunki
Country [2] 252297 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271990 0
Helsinki University Central Hospital, Ethical committe of Medicine
Ethics committee address [1] 271990 0
Biomedicum Helsinki 2 C,
PO Box 705
00029 HUS
Finland
Ethics committee country [1] 271990 0
Finland
Date submitted for ethics approval [1] 271990 0
Approval date [1] 271990 0
04/10/2010
Ethics approval number [1] 271990 0
Dnro HUS 254/13/03/01/10

Summary
Brief summary
Use of inappropriate drugs among insititutionalized older people is very common and may lead to unnecessary hospitalizations and impaired quality of life. The aim of this study is to investigate whether training nursing home staff (nurses, consulting physician) reduces the use of inappropriate, anticholinergic and psychotropic drugs among institutionalized older people. We also investigate the effects of intervention on older people's HrQOL, cognition and use and costs of health services, especially hospitalizations. The primary endpoint will be number of inappropriate, anticholinergic and psychotropic drugs and the secondary outcomes will be older people's HrQOL, cognition and use and costs of health services. The wards will be randomized into two groups,and the staff in the intervention wards will receive training concerning the use of drugs in older people, to identify inappropriate, anticholinergic and psychotropic drugs and their harmful effects. The intervenion wards will have an appointed nurse who is responsible to identify harmful drugs among the residents in her wards and to take these problems to the consulting doctor who is responsible to comprehensively take care of the patient. The trial will last for 12 months, the assessment time points will 0,6 and 12 months.
Trial website
Trial related presentations / publications
Pitkala KH, Juola AL, Soini H, Laakkonen ML, Teramura-Gronblad M, Kautiainen H,
Bjorkman M. Reducing inappropriate, anticholinergic and psychotropic drugs among
older residents in assisted living facilities - a randomized controlled trial. Study
protocol. Trials 2012; Jun 18;13(1):85.
Juola AL, Pylkkanen S, Bjorkman M, Soini H, Finne-Soveri UH, Kautiainen H, Pitkala KH.
Feasibility and baseline findings of a trial Optimizing Drug Treatment among Older People in Assisted Living Facilities in Helsinki. Randomized, Controlled Trial. Eur Geriatric Med 2014;5:195-9.
Pitkala KH, Juola AL, Kautiainen H, Soini H, Finne-Soveri H, Bell JS, Bjorkman MP. Effects of educational intervention to reduce harmful drugs among older people. J Am Med Dir Assoc. 2014 Dec;15(12):892-898.
Juola AL, Bjorkman MP, Kautiainen H, Pylkkanen S, Finne-Soveri H, Soini H, Bell JS,
Pitkala KH. Nursing staff education to reduce potentially harmful medication use among older people in assisted living facilities: effects of randomized controlled trial on cognition and falls. Drugs Aging. 2015 Nov;32(11):947-55.
Juola AL, Soini H, Kautiainen H, Bell JS, Pitkala KH. Burden in the use of harmful medication among residents in assisted living facilities. JAMDA 2016 Mar 1;17(3):276.e9-276.e14.


Public notes

Contacts
Principal investigator
Name 33269 0
A/Prof Kaisu H Pitkala
Address 33269 0
University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Finland
Country 33269 0
Finland
Phone 33269 0
+358503385546
Fax 33269 0
Email 33269 0
kaisu.pitkala@helsinki.fi
Contact person for public queries
Name 16516 0
Prof Kaisu Pitkälä
Address 16516 0
University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Country 16516 0
Finland
Phone 16516 0
+358503385546
Fax 16516 0
+358919127536
Email 16516 0
kaisu.pitkala@helsinki.fi
Contact person for scientific queries
Name 7444 0
A/Prof Kaisu Pitkala
Address 7444 0
University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Country 7444 0
Finland
Phone 7444 0
+358503385546
Fax 7444 0
Email 7444 0
kaisu.pitkala@helsinki.fi

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary