Clinical trial NCT02545257: Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care
Official title: Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Therapy, Combination
Inappropriate Prescribing
Polypharmacy
Keywords: Aged people
Home care
Drug related problems, DRPs
Coordinated medication management model
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: City of Lohja, Services for Aged People
name: Lohjan 1. Apteekki
name: Social Insurance Institution, Finland
First posted: 2015-09-09
Enrollment: 191
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Home-dwelling over 65 year-old persons receiving regular home care from the City of Lohja

Exclusion Criteria:

* Home care is not given regularly

Primary outcomes:
measure: GDS-15 (Geriatric Depression Scale)
timeFrame: Change from baseline at 12 and 24 months
measure: MMSE (Mini-Mental State Examination)
timeFrame: Change from baseline at 12 and 24 months
measure: MNA (Malnutrition Assessment)
timeFrame: Change from baseline at 12 and 24 months
measure: Time to rise from a chair and return to the seated position 5 times (Lower extremity function).
timeFrame: Change from baseline at 12 and 24 months
measure: Orthostatic hypotension (Short test, Freeman et al. 2011)
timeFrame: Change from baseline at 12 and 24 months
measure: AUDIT-C (Alcohol Use Disorder Identification Test, version C)
timeFrame: Change from baseline at 12 and 24 months
measure: UDI-6 (Urinary Distress Inventory)
timeFrame: Change from baseline at 12 and 24 months
measure: Rava (Functioning and disability, Finnish Consulting Group)
timeFrame: Change from baseline at 12 and 24 months
measure: Potentially inappropriate medicines (PIM) (Clinically significant drug-drug interactions, potentially inappropriate medicines for aged), identified from medication list review chart
timeFrame: Change from baseline at 12 and 24 months
Secondary outcomes:
measure: Use of health care services: visits to physician
timeFrame: at 12 and 24 months from baseline
measure: Use of health care services: hospital days
timeFrame: at 12 and 24 months from baseline
measure: Use of health care services: home care services
timeFrame: at 12 and 24 months from baseline
Other outcomes:
Locations:
city: Lohja
country: Finland
facility: 1st Pharmacy of Lohja
city: Lohja
country: Finland
facility: Services for aged people
Study officials:
affiliation: University of Helsinki
name: Marja SA Airaksinen, Professor
role: STUDY_CHAIR
affiliation: University of Helsinki
name: Juha T Puustinen, Docent
role: STUDY_DIRECTOR
References:
citation: Dimitrow MS, Leikola SN, Kivela SL, Passi S, Lukkari P, Airaksinen MS. Feasibility of a practical nurse administered risk assessment tool for drug-related problems in home care. Scand J Public Health. 2015 Nov;43(7):761-9. doi: 10.1177/1403494815591719. Epub 2015 Jul 7.
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citation: Toivo T, Airaksinen M, Dimitrow M, Savela E, Pelkonen K, Kiuru V, Suominen T, Uunimaki M, Kivela SL, Leikola S, Puustinen J. Enhanced coordination of care to reduce medication risks in older home care clients in primary care: a randomized controlled trial. BMC Geriatr. 2019 Nov 27;19(1):332. doi: 10.1186/s12877-019-1353-2.