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Completed

NCT Number: NCT02545257

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1st Pharmacy of Lohja, Lohja, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coordinated medication management model

Other

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

Primary outcomes

  1. GDS-15 (Geriatric Depression Scale)

    Time frame: Change from baseline at 12 and 24 months

  2. MMSE (Mini-Mental State Examination)

    Time frame: Change from baseline at 12 and 24 months

    Cognitive ability

  3. MNA (Malnutrition Assessment)

    Time frame: Change from baseline at 12 and 24 months

  4. 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

  5. Orthostatic hypotension (Short test, Freeman et al. 2011)

    Time frame: Change from baseline at 12 and 24 months

  6. AUDIT-C (Alcohol Use Disorder Identification Test, version C)

    Time frame: Change from baseline at 12 and 24 months

  7. UDI-6 (Urinary Distress Inventory)

    Time frame: Change from baseline at 12 and 24 months

  8. Rava (Functioning and disability, Finnish Consulting Group)

    Time frame: Change from baseline at 12 and 24 months

  9. 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).

Secondary outcomes

  1. Use of health care services: visits to physician

    Time frame: at 12 and 24 months from baseline

    Number of visits (previous 3 months)

  2. Use of health care services: hospital days

    Time frame: at 12 and 24 months from baseline

    Number of hospital days (previous 3 months)

  3. Use of health care services: home care services

    Time frame: at 12 and 24 months from baseline

    Services delivered to home (previous 3 months)

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 9, 2015
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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