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

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ClinicalTrials.gov Identifier: NCT02545257
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : March 12, 2019
Sponsor:
Collaborators:
City of Lohja, Services for Aged People
Lohjan 1. Apteekki
Social Insurance Institution, Finland
Information provided by (Responsible Party):
Terhi Toivo, 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.

Condition or disease Intervention/treatment Phase
Drug Therapy, Combination Inappropriate Prescribing Polypharmacy Other: Coordinated medication management model Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2018

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)



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545257


Locations
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Finland
1st Pharmacy of Lohja
Lohja, Finland, 08100
Services for aged people
Lohja, Finland, 08100
Sponsors and Collaborators
University of Helsinki
City of Lohja, Services for Aged People
Lohjan 1. Apteekki
Social Insurance Institution, Finland
Investigators
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Study Chair: Marja SA Airaksinen, Professor University of Helsinki
Study Director: Juha T Puustinen, Docent University of Helsinki
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Terhi Toivo, Project coordinator, MSc (Pharm), PhD student, University of Helsinki
ClinicalTrials.gov Identifier: NCT02545257    
Other Study ID Numbers: 153/13/03/00/2015
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Keywords provided by Terhi Toivo, University of Helsinki:
Aged people
Home care
Drug related problems, DRPs
Coordinated medication management model