An Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

Study Overview
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Brief Summary
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The aim of this randomized controlled study is to investigate if medication reviews performed by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive failure. Four hundred and sixty patients will be recruited and randomized to control (usual care) and intervention group (enhanced service in which a pharmacist is part of the health care team). Six months after the last patient of the 460 has been discharged the study will be closed. Data about the number of readmissions and visits to the emergency room will be collected during the six-month follow-up and also, the costs associated with each visit or admission. Time until institutionalization will be compared between intervention group and control group.

Official Title
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A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Other: Medication review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with dementia or cognitive impairment Patients ≥ 65 years Exclusion Criteria: Patients previously admitted to the study wards during the study period

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication review<br> | Other: Medication review<br>* In the intervention, the pharmacist will evaluate: Is there an indication for the drug? Has the drug desired effect? Is the dose correct and dosing scheme correct? Side effects, contraindications, inappropriate drugs Interactions Treatment time Cost effectiveness Adherence to recommendation list Problems with handling the drugs (for example crushing of the tablets) Untreated indication Double medications Administration of drugs<br>|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Readmitted Because of Drug Related Reasons |  | Six months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group. | To evaluate the economic impact of clinical pharmacist engagement in hospital ward teams for medication therapy management in older patients with dementia or cognitive impairments. | Six months follow-up | 
| Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group. |  | Six months follow-up | 
| Frequency of Emergency Department Visits During the 6-month Follow-up. |  | Six months follow-up | 
| Change in the Number of Participants With Potentially Inappropriate Medications, According to the Swedish National Board of Health and Welfare, at Admission and Discharge Between Intervention and Control Group | Six drug-specific quality indicators as defined by the Swedish National Board of Health and Welfare were used to define use of Potentially inappropriate medications (PIMs) in this study. Four out of the six selected indicators belong to a group where drug-use should be as low as possible regardless of indication: anticholinergic drugs (as defined by the Swedish National Board of Health and Welfare, propiomazine, tramadol, and long-acting benzodiazepines. The two remaining indicators are classified as preparations for which correct and current indication is of particular importance: antipsychotic drugs (N05A except lithium) and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). In the present study, a PIM was defined as exposure to at least one of the drugs mentioned among the six quality indicators. | Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug related problems