Overview

This trial is active, not recruiting.

Conditions drug therapy, combination, inappropriate prescribing, polypharmacy
Treatment coordinated medication management model
Sponsor Helsinki University
Collaborator City of Lohja, Services for Aged People
Start date September 2015
End date October 2017
Trial size 191 participants
Trial identifier NCT02545257, 153/13/03/00/2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
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.
coordinated medication management model
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
(No Intervention)
Normal, standard care (control group)

Primary Outcomes

Measure
GDS-15 (Geriatric Depression Scale)
time frame: Change from baseline at 12 and 24 months
MMSE (Mini-Mental State Examination)
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

Secondary Outcomes

Measure
Potentially inappropriate medicines (PIM) (Clinically significant drug-drug interactions, potentially inappropriate medicines for aged), identified from medication list review chart
time frame: at 12 and 24 months from baseline
Use of health care services: visits to physician
time frame: at 12 and 24 months from baseline
Use of health care services: hospital days
time frame: at 12 and 24 months from baseline
Use of health care services: home care services
time frame: at 12 and 24 months from baseline

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Helsinki University.