Patient Safety Clinical Trial
Official title:
A Multicentre Study on the Effects of Self-administration of Medication During Hospitalization on Medication Safety, Adherence, and Patient Satisfaction in Dutch Hospitals
During hospitalization, medication administration errors (MAEs) occur daily in health care and can lead to serious harm. Improvement of medication safety is a major concern to policymakers and health care workers. Inpatient self-administration of medication (SAM) during hospital admission could be a way to reduce MAEs. Therefore the aim of this study is to determine the effect of inpatient self-administration of medication on the number of medication administration errors during hospitalization.
Objective: the main objective of this study is to determine the effect of inpatient
self-administration of medication on the number of medication administration errors during
hospitalization. The secondary objectives of this study are to determine:
1. The effect of inpatient self-administration of medication on the severity of medication
administration errors during hospitalization
2. The effect of inpatient self-administration on medication adherence after
hospitalization
3. The effect of inpatient self-administration of medication on patient satisfaction during
hospitalization
4. The effect of inpatient self-administration of medication on staff satisfaction during
hospitalization
Study design: multicentre prospective quasi-experimental study with a pre-post design
Study population: hospitalized ≥ 16 years old patients
Intervention: the implementation of self-administration of medication by hospitalized
patients. SAM will be compared to standard care.
Main study parameters: The primary outcome measure of the study is the proportion of
medication administrations with one or more medication administration errors (MAEs).
Secondary outcome measures will be: severity of MAEs, medication adherence after
hospitalization, patient satisfaction during hospitalization, and staff satisfaction. For all
outcome measures the effect of SAM will be compared to standard care.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: all subjects have to fulfil two questionnaires, one during hospitalization and
one approximately three months after leaving the studied ward, e.g. hospital discharge or
transfer. The subjects that are included in de post study period have to self-administrate
medication that's suitable for SAM. The risk of SAM during hospitalization is estimated as
the risk patients are at home when using medication. The burden of SAM is classified as low
because results of a recent questionnaire shows that admitted patients have the urge to act
in SAM schemes.
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