Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

Study Overview
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Brief Summary
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The purpose of this study is to determine whether additional pharmaceutical care for elderly patients (home-cared patients, nursing-home residents) has a positive impact on drug-related readmissions.

Official Title
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Medication Safety of Elderly Patients in Hospital and Ambulatory Setting Considering the Transitions of Care for Home-cared Patients and Nursing Home Residents

Conditions
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Elderly, Pharmaceutical Care, Hospital Readmission, Health Services for the Aged, Medication Safety

Intervention / Treatment
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* Other: Pharmaceutical Care Service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient 65 years old or older patient admitted to one of the project wards minimum hospitalization: 3 days written informed consent (patient or the legal representative) current medication of the patient at hospitalization Exclusion Criteria: patients included in this 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: standard care<br>Standard care (by German definition), traditional care by physician and nurse on the ward | |
| Other: Intensified standard care<br>Intensified standard care: traditional care by physician and nurse, additional pharmaceutical care by a pharmacist during hospitalization | Other: Pharmaceutical Care Service<br>* Checking medication under safety considerations (medication at admission, hospitalization, discharge); recommendations for potentially inappropriate medication (PRISCUS-criteria),<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug-related readmission |  | one year after discharge from the cooperating ward | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug events |  | during hospital stay on cooperating wards(continuous data collection during routine ward rounds;hence,duration of data collection is dependent on individual hospital stay of each patient, up to 1 year) and 1 year after discharge from the cooperating ward | 
| Number of prescribed potentially inappropriate medication (PRISCUS-criteria) | The PRISCUS list was developed in 2010 for the German market. Potentially inappropriate medications were judged as inappropriate by an expert panel using the Delphi technique. [Holt et al., Dtsch Arztebl 2010] | during hospital stay on cooperating wards(continuous data collection during routine ward rounds;hence,duration of data collection is dependent on individual hospital stay of each patient, up to 1 year) and 1 year after discharge from the cooperating ward | 
| time to readmission |  | one year after discharge from the cooperating ward | 
| Number of accepted recommendations in the intervention group |  | during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group | 
| time for intervention | time recording for pharmaceutical care service | during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group | 
| drug-related problem |  | during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group | 
| number of changes in medication after discharge |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication safety, elderly, pharmaceutical care, hospital readmission, drug-related readmission, Health Services for the Aged