An interventional study of Coordinated medication management model in Drug Therapy, Combination, Inappropriate Prescribing and Polypharmacy, sponsored by University of Helsinki. Completed at 2 sites in Finland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by University of Helsinki · Not applicable, Interventional, and Health services research
The objective of this randomized controlled trial is to develop a coordinated, multiprofessional medication management model for home-dwelling aged in primary care and to study the effectiveness of this model. The main hypothesis is that the new model helps to identify aged people having potential risks with their medications and thus allows solving these risks.
The demand for long-term home health care services is increasing due the demographic and societal developments. Aged people needing home care are increasingly older, have many chronic diseases and use multiple medicines and thus, are at high risk for drug-related problems (DRPs). In Finland, national and local healthcare and aged care strategies target to allowing aged people (over 65 years) living in their own homes as long as possible. This minimizes the costs of institutionalized care and also targets to add the quality of life of aged people. New approaches and service models are needed to meet these challenges.
The present study focuses on the development of a coordinated medication management model which aims to ensure the safe medication practises for home-dwelling aged in primary care. In the previous parts of this study project were developed a model for comprehensive medication review process (CMR) and a Drug-Related Problem Risk Assessment Tool. The present study uses a multistage intervention in which medications are reviewed (prescription review) in a community pharmacy using the SFINX-database to identify clinically significant drug-drug interactions and the Salko-database which identifies potentially inappropriate medications for aged people. In the next stage practical nurses use the Drug-Related Problem Risk Assessment Tool to identify potential risks. The following stages are based on the results from the risk assessment tool. Potential options are, e.g.,physician consultation, more frequent home care visits, counselling given by the community pharmacy or comprehensive medication review (CMR). The CMR process is only targeted to a limited group of study participants with clinically significant DRP who probably will benefit from more comprehensive CMR.
University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In addition to normal, standard care, participants allocated to intervention group will receive a coordinated medication management model containing prescription review, drug-related problems (DRP) risk assessment and required action based on the DRP risk assessment.
Other: Coordinated medication management model
Normal, standard care (control group)
Stage I: a prescription review conducted by community pharmacists Stage II: practical nurse-administered Drug-related Problem Risk Assessment Tool Stage III: Required health care action based on the result of the DRP -Risk Assessment Tool
GDS-15 (Geriatric Depression Scale)
Time frame: Change from baseline at 12 and 24 months
MMSE (Mini-Mental State Examination)
Cognitive ability
Time frame: Change from baseline at 12 and 24 months
MNA (Malnutrition Assessment)
Time frame: Change from baseline at 12 and 24 months
Time to rise from a chair and return to the seated position 5 times (Lower extremity function).
Time frame: Change from baseline at 12 and 24 months
Orthostatic hypotension (Short test, Freeman et al. 2011)
Time frame: Change from baseline at 12 and 24 months
AUDIT-C (Alcohol Use Disorder Identification Test, version C)
Time frame: Change from baseline at 12 and 24 months
UDI-6 (Urinary Distress Inventory)
Time frame: Change from baseline at 12 and 24 months
Rava (Functioning and disability, Finnish Consulting Group)
Time frame: Change from baseline at 12 and 24 months
Potentially inappropriate medicines (PIM) (Clinically significant drug-drug interactions, potentially inappropriate medicines for aged), identified from medication list review chart
PIMs are identified with prescription review using SFINX database (clinically significant drug-drug interactions) and Salko database (e.g., for identifying potentially inappropriate medicines for the aged, anticholinergic and serotonergic load).
Time frame: Change from baseline at 12 and 24 months
Use of health care services: visits to physician
Number of visits (previous 3 months)
Time frame: at 12 and 24 months from baseline
Use of health care services: hospital days
Number of hospital days (previous 3 months)
Time frame: at 12 and 24 months from baseline
Use of health care services: home care services
Services delivered to home (previous 3 months)
Time frame: at 12 and 24 months from baseline
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of Helsinki