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

Not Applicable

Terminated

• Conditions: Patient Safety; Medication Safety; Patient Empowerment
• Interventions: Behavioral: Self-administration of medication (SAM)

• Registration Number: NCT03728855
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed 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:

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Study Start: 2018-12-01
• Primary Completion: 2019-05-02
• Study Completion: 2019-05-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 193

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Self-administration of medication (SAM)	Self-administration of medication (SAM)	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.

Primary Outcome Measures

Name	Time	Method
Proportion of medication administration errors	2 weeks	The doctor's prescriptions as noted in the CPOE system will be compared to the observed medication administration and any discrepancy will be marked as an MAE. The number of erroneous medication administrations (containing 1 or more errors) will be divided by the number of observed drug administrations plus the number of omissions (concept of opportunities).

Secondary Outcome Measures

Name	Time	Method
Severity of MAEs	2 weeks	Severity of MAEs will be determined by two healthcare professionals, a physician and a pharmacist.To classify the severity of MAEs the NCC MERP Index for categorizing medication errors will be used. Thereafter consensus will be reached. The experts will be blinded to the period (usual care or intervention) during which the problem occurred.
Medication adherence after hospitalization	1 year	With the use of the pharmacy refill dates the Medication Refill Adherence (MRA) is calculated.; - 1 year after inclusion: pharmacy refill data will be collected
Patient satisfaction during hospitalization	7 days	Patient satisfaction will be measured by the Beliefs about Medicine Questionnaire (BMQ).
Staff satisfaction	1 year	Staff satisfaction will be measured using The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). These are four-item measures of implementation outcomes that are often considered "leading indicators" of implementation success. These measures can be administered to a wide range of stakeholders to determine the extent to which they believe an intervention or an implementation strategy is acceptable, appropriate, and feasible. At the end of the study hospital staff will be asked to complete the questionnaires.

Trial Locations

Locations (8)

Sint Maartenskliniek; 🇳🇱 Ubbergen, Gelderland, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Zuid-Holland, Netherlands

ETZ; 🇳🇱 Tilburg, Noord-Brabant, Netherlands

MUMC+; 🇳🇱 Maastricht, Limburg, Netherlands

Meander Medisch Centrum; 🇳🇱 Amersfoort, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 's-Hertogenbosch, Noord-Brabant, Netherlands