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

March 8, 2019 updated by: Terhi Toivo, University of Helsinki
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Lohja, Finland, 08100
        • 1st Pharmacy of Lohja
      • Lohja, Finland, 08100
        • Services for aged people

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: 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: Control group (standard care)
Normal, standard care (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GDS-15 (Geriatric Depression Scale)
Time Frame: Change from baseline at 12 and 24 months
Change from baseline at 12 and 24 months
MMSE (Mini-Mental State Examination)
Time Frame: Change from baseline at 12 and 24 months
Cognitive ability
Change from baseline at 12 and 24 months
MNA (Malnutrition Assessment)
Time Frame: Change from baseline at 12 and 24 months
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
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
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
Change from baseline at 12 and 24 months
UDI-6 (Urinary Distress Inventory)
Time Frame: Change from baseline at 12 and 24 months
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
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).
Change from baseline at 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of health care services: visits to physician
Time Frame: at 12 and 24 months from baseline
Number of visits (previous 3 months)
at 12 and 24 months from baseline
Use of health care services: hospital days
Time Frame: at 12 and 24 months from baseline
Number of hospital days (previous 3 months)
at 12 and 24 months from baseline
Use of health care services: home care services
Time Frame: at 12 and 24 months from baseline
Services delivered to home (previous 3 months)
at 12 and 24 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Social Insurance Institution, Finland
City of Lohja, Services for Aged People
Lohjan 1. Apteekki

Investigators

  • Study Chair: Marja SA Airaksinen, Professor, University of Helsinki
  • Study Director: Juha T Puustinen, Docent, University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 153/13/03/00/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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