Medication Reconciliation in Comparison to an Extensive Medication Safety Check

Study Overview
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Brief Summary
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The purpose of this study is to determine wether an extensive medication safety check has a greater impact on the incidence of adverse drug events than medication reconciliation or no intervention.

Official Title
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Pilot Project to Investigate the Influence of Medication Reconciliation and an Extensive Medication Safety Check on the Number of Adverse Drug Events in the Elderly

Conditions
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Elderly, Adverse Drug Event

Intervention / Treatment
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* Other: Medication Reconciliation
* Other: Pharmaceutical Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 65 years and older written informed consent patient or the legal representative existing medication therapy at hospitalization admission to one of the project wards via emergency department (non elective) Exclusion Criteria: - patients included in the study previously

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 |
| --- | --- |
| No Intervention: Controll-Group<br>Patient randomized to the Control-Group will receive the traditional care by physician and nurse on the ward. | |
| Experimental: MedRec-Group<br>Patient randomized to the MedRec-Group will receive the traditional care by physician and nurse on the ward and additional pharmacist led medication reconciliation. | Other: Medication Reconciliation<br>* Pharmacist take the best possible medication history (BPMH), comparison of the BPMH with the admission order (AMO), clarify and solve al discrepancies between the BPMH and the AMO.<br>|
| Experimental: AMTS-Group<br>Patient randomized to the AMTS-Group will receive the traditional care by physician and nurse on the ward and additional pharmaceutical care by a pharmacist. | Other: Pharmaceutical Care<br>* Checking medication under safety considerations (medication at admission, during hospital stay, at discharge); recommendations for inappropriate medication (e.g. contraindications or interactions) or medication related problems. Pharmaceutical care includes Medication Reconciliation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse drug events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the clinical relevance of medication related problems as determined by the French Society of Clinical Pharmacy | Severity scale for medication related problems: minor, significative, major, critical, catastrophic | 1 year | 
| Assessment of the clinical relevance of discrepancies as determined by the French Society of Clinical Pharmacy | Severity scale for discrepancies: minor, significative, major, critical, catastrophic | 1 year | 
| number of medication related problems |  | 1 year | 
| number of discrepancies |  | 1 year | 
| duration of taking the best possible medication history | The duration is measured in minutes. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly Patients, Medication Safety, Pharmaceutical Care, Medication Reconciliation