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Clinical Trials/NCT02545257
NCT02545257
Completed
Not Applicable

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

University of Helsinki2 sites in 1 country191 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Drug Therapy, Combination
Sponsor
University of Helsinki
Enrollment
191
Locations
2
Primary Endpoint
GDS-15 (Geriatric Depression Scale)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Terhi Toivo

Project coordinator, MSc (Pharm), PhD student

University of Helsinki

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

Outcomes

Primary Outcomes

GDS-15 (Geriatric Depression Scale)

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

UDI-6 (Urinary Distress Inventory)

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

Potentially inappropriate medicines (PIM) (Clinically significant drug-drug interactions, potentially inappropriate medicines for aged), identified from medication list review chart

Time Frame: Change 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)

Time Frame: Change from baseline at 12 and 24 months

Cognitive ability

MNA (Malnutrition Assessment)

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

Secondary Outcomes

  • Use of health care services: visits to physician(at 12 and 24 months from baseline)
  • Use of health care services: hospital days(at 12 and 24 months from baseline)
  • Use of health care services: home care services(at 12 and 24 months from baseline)

Study Sites (2)

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