Clinical trial NCT03728855: Effects of Self-administration of Medication During Hospitalization on Medication Safety, Adherence, and Patient Satisfaction in Dutch Hospitals
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Medication Safety
Patient Safety
Patient Empowerment
Keywords: Self-administration of medication
SAM
Medication Safety
Patient Empowerment
Patient Satisfaction
Staff Satisfaction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2018-11-02
Enrollment: 193
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The intervention of this study is the implementation of self-administration of medication (SAM) by hospitalized patients. SAM will be compared to standard care.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Proportion of medication administration errors
timeFrame: 2 weeks
Secondary outcomes:
measure: Severity of MAEs
timeFrame: 2 weeks
measure: Medication adherence after hospitalization
timeFrame: 3 months
measure: Medication adherence after hospitalization
timeFrame: 1 year
measure: Patient satisfaction during hospitalization
timeFrame: 7 days
measure: Patient satisfaction during hospitalization
timeFrame: 7 days
measure: Staff satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
state: Gelderland
city: Maastricht
country: Netherlands
facility: MUMC+
state: Limburg
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: ETZ
state: Noord-Brabant
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
state: Zuid-Holland
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
Study officials:
affiliation: Radboudumc/ Sint Maartenskliniek
name: Bart van den Bemt, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: