Effects of Self-administration of Medication During Hospitalization on Medication Safety, Adherence, and Patient Satisfaction in Dutch Hospitals (MIEB)

Radboud University Medical Center

Status: Terminated

Conditions: Patient Safety; Patient Empowerment; Medication Safety

Treatments: Behavioral: Self-administration of medication (SAM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03728855

UMCN-AKF-18.02

Details and patient eligibility

About

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.

Full description

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:

The effect of inpatient self-administration of medication on the severity of medication administration errors during hospitalization The effect of inpatient self-administration on medication adherence after hospitalization The effect of inpatient self-administration of medication on patient satisfaction during hospitalization 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.

Enrollment: 193 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients (≥ 16 years old) admitted to the ward who use medication or will be using medication at home after hospital discharge and are able to administer (part of) this medication themselves

Exclusion criteria

• Not providing informed consent
• The use of a medication box without original medication boxes
• The use of medication pre-packaged by automated dispensing system
• The need of homecare support to administer medication
• The need of an informal caretaker to help with medication administration
• Admitted from a nursing home and medication is under supervision of the staff
• Not understanding the Dutch language, written or spoken
• The subject is not capable of managing SAM (due to mental or physical state)

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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193 participants in 2 patient groups

Standard care

No Intervention group

Description:

Based on an (electronic) order placed by a physician, nurses collect medication and provide patients with the ordered medication in a timely matter. Nurses document the administration either in an electronic medical record or on paper.

Self-administration of medication (SAM)

Experimental group

Description:

During SAM medication is stocked at the patient's bedside. When medication is scheduled to be administered, patients collect those form their own stock, administer, and document the administration by themselves. Once daily nurses check whether patients succeeded in administration for all prescriptions of the last 24 hours. Each day, patients are qualified for SAM. In the case patients do not meet the criteria of SAM, they will be excluded from SAM.

Treatment:

Behavioral: Self-administration of medication (SAM)