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Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care

Not Applicable
Completed
Conditions
Inappropriate Prescribing
Drug Therapy, Combination
Polypharmacy
Interventions
Other: Coordinated medication management model
Registration Number
NCT02545257
Lead Sponsor
University of Helsinki
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
191
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Active comparatorCoordinated medication management modelIn 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.
Primary Outcome Measures
NameTimeMethod
GDS-15 (Geriatric Depression Scale)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).Change from baseline at 12 and 24 months
UDI-6 (Urinary Distress Inventory)Change from baseline at 12 and 24 months
Orthostatic hypotension (Short test, Freeman et al. 2011)Change from baseline at 12 and 24 months
AUDIT-C (Alcohol Use Disorder Identification Test, version C)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 chartChange from baseline at 12 and 24 months

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).

MMSE (Mini-Mental State Examination)Change from baseline at 12 and 24 months

Cognitive ability

MNA (Malnutrition Assessment)Change from baseline at 12 and 24 months
Rava (Functioning and disability, Finnish Consulting Group)Change from baseline at 12 and 24 months
Secondary Outcome Measures
NameTimeMethod
Use of health care services: visits to physicianat 12 and 24 months from baseline

Number of visits (previous 3 months)

Use of health care services: hospital daysat 12 and 24 months from baseline

Number of hospital days (previous 3 months)

Use of health care services: home care servicesat 12 and 24 months from baseline

Services delivered to home (previous 3 months)

Trial Locations

Locations (2)

1st Pharmacy of Lohja

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Lohja, Finland

Services for aged people

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Lohja, Finland

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