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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Drug Therapy, Combination, Inappropriate Prescribing, Polypharmacy

Intervention / Treatment
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* Other: Coordinated medication management model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active comparator<br>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<br>* 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<br>|
| No Intervention: Control group (standard care)<br>Normal, standard care (control group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GDS-15 (Geriatric Depression Scale) |  | Change from baseline at 12 and 24 months | 
| MMSE (Mini-Mental State Examination) | Cognitive ability | Change from baseline at 12 and 24 months | 
| MNA (Malnutrition Assessment) |  | 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). |  | Change from baseline at 12 and 24 months | 
| Orthostatic hypotension (Short test, Freeman et al. 2011) |  | Change from baseline at 12 and 24 months | 
| AUDIT-C (Alcohol Use Disorder Identification Test, version C) |  | Change from baseline at 12 and 24 months | 
| UDI-6 (Urinary Distress Inventory) |  | Change from baseline at 12 and 24 months | 
| Rava (Functioning and disability, Finnish Consulting Group) |  | 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 | 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 | Number of visits (previous 3 months) | at 12 and 24 months from baseline | 
| Use of health care services: hospital days | Number of hospital days (previous 3 months) | at 12 and 24 months from baseline | 
| Use of health care services: home care services | Services delivered to home (previous 3 months) | at 12 and 24 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged people, Home care, Drug related problems, DRPs, Coordinated medication management model