Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes

Study Overview
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Brief Summary
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Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity, activity of daily living and neuropsychiatric symptoms. Design: A randomized, controlled, single blinded interventional study in Norwegian nursing homes.

Detailed Description
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Several studies have claimed that drugs showing anticholinergic activity in vitro cause high levels of serum anticholinergic activity in vivo that might cause impaired cognitive and functional functions in elderly. Pathophysiological changes in Alzheimer's dementia makes these patients particularly vulnerable for anticholinergic cognitive impairments. The PRADA-study is the first interventional study evaluating the clinical effects of reducing drug-induced anticholinergic load in patients with dementia. This is also the first interventional study in the Nordic countries evaluating the clinical effects of clinical pharmacy.

Official Title
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Pharmacist-initiated Reduction of Anticholinergic Drug Activity

Conditions
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Anticholinergic Side Effects

Intervention / Treatment
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* Other: Multidisciplinary drug reviews by pharmacist and physician


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Long-term nursing home patients with none, mild or moderate dementia (evaluated by CDR9,using drugs with a total anticholinergic burden that might lead to adverse events. Exclusion Criteria: Not able to perform the testes because of physical or psychiatric illnesses.
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment arm<br>Reduction of anticholinergic drug effects by pharmacist review | Other: Multidisciplinary drug reviews by pharmacist and physician<br>* Reduction of anticholinergic drug effects by pharmacist review<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CERADS word list measuring immediately and delayed recall |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth dryness |  | 4 years | 
| ADL |  | 4 years | 
| Serum anticholinergic activity |  | 4 years | 
| CERADS word list recognition |  | 4 years | 
| MMSE |  | 4 years | 
| NPI |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticholinergic drugs, adverse events, elderly, clinical pharmacist, Evaluate the clinical effects of reducing anticholinergic in elderly