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

NCT ID: NCT03728855

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-05-02

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.

Conditions

Medication Safety; Patient Safety; Patient Empowerment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Standard care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Self-administration of medication (SAM)

Intervention Type: BEHAVIORAL

Patients use medication from their own stock, self-administered.

Interventions

Self-administration of medication (SAM)

Patients use medication from their own stock, self-administered.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bart van den Bemt, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboudumc/ Sint Maartenskliniek

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Sint Maartenskliniek

Ubbergen, Gelderland, Netherlands

MUMC+

Maastricht, Limburg, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

ETZ

Tilburg, North Brabant, Netherlands

Groene Hart Ziekenhuis

Gouda, South Holland, Netherlands

Meander Medisch Centrum

Amersfoort, , Netherlands

Countries

Netherlands

Other Identifiers

UMCN-AKF-18.02

Identifier Type: -

Identifier Source: org_study_id