Medication SafetyMIEBNCT03728855
Effects of Self-administration of Medication During Hospitalization on Medication Safety, Adherence, and Patient Satisfaction in Dutch Hospitals
A study testing Self-administration of medication (SAM) in people with Medication Safety and Patient Safety, run by Radboud University Medical Center at 8 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Medication Safety, Patient Safety, Patient Empowerment
- What is being tested?
- Self-administration of medication (SAM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 8 sitesNetherlands
- Study dates
- 1 Dec 2018to 2 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223 GZ
Meander Medisch Centrum
Amersfoort, 3813 TZ
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Groene Hart Ziekenhuis
Gouda, South Holland, 2803 HH
MUMC+
Maastricht, Limburg, 6229 HX
Radboudumc
Nijmegen, Gelderland, 6525 GA
ETZ
Tilburg, North Brabant, 5042 AD
Sint Maartenskliniek
Ubbergen, Gelderland, 6574 NA
About this study
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.
Read the 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:
- 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.
- Conditions
- Medication Safety, Patient Safety, Patient Empowerment
- Being tested
- Self-administration of medication (SAM)
- Keywords
- Self-administration of medication, SAM, Medication Safety, Patient Empowerment, Patient Satisfaction, Staff Satisfaction
- Medical subject headings
- Patient Participation, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administration of medication (SAM)Behavioural
Patients use medication from their own stock, self-administered.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | 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 | 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. Receives: Behavioral: Self-administration of medication (SAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of medication administration errors
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).
Measured: 2 weeks
Secondary outcomes (6)
Severity of MAEs
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.
Measured: 2 weeks
Medication adherence after hospitalization
Medication adherence after hospitalisation will be measured using the Medication Adherence Reasons Scale (MAR-Scale). The MAR-Scale measures medication non-adherence based on the reasons for non-adherence so that each reason can be matched with a corresponding intervention. Approximately three months after hospitalization, a questionnaire consisting of six questions concerning the patient's medication use will be sent to all included patients by email.
Measured: 3 months
Medication adherence after hospitalization
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
Measured: 1 year
Patient satisfaction during hospitalization
Patient satisfaction will be measured by the visual analogue scale (VAS) for patient satisfaction.
Measured: 7 days
Patient satisfaction during hospitalization
Patient satisfaction will be measured by the Beliefs about Medicine Questionnaire (BMQ).
Measured: 7 days
Staff satisfaction
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Dec 2018
- Primary completion2 May 2019
- Study completion2 May 2019
Why it stopped: Difficult recruitment, despite several interventions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication SafetyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Bart van den Bemt, PharmD, PhD, Principal investigator, Radboudumc/ Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728855
- Sponsor's protocol ID
- UMCN-AKF-18.02
- Acronym
- MIEB
- Status last verified
- Sep 2020
- First submitted
- 5 Oct 2018
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03728855
- Acronym / sponsor ID
- MIEB / UMCN-AKF-18.02
- Conditions
- Medication Safety, Patient Safety, Patient Empowerment
- Keywords
- Self-administration of medication, SAM, Medication Safety, Patient Empowerment, Patient Satisfaction, Staff Satisfaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult recruitment, despite several interventions.
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –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 | Behavioral: 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administration of medication (SAM)Patients use medication from their own stock, self-administered. | Behavioural | Self-administration of medication (SAM) |
Primary outcome
Proportion of medication administration errors
Time frame: 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).
6 secondary outcomes
Severity of MAEs
Time frame: 2 weeks
Medication adherence after hospitalization
Time frame: 3 months
Medication adherence after hospitalization
Time frame: 1 year
Patient satisfaction during hospitalization
Time frame: 7 days
Patient satisfaction during hospitalization
Time frame: 7 days
Staff satisfaction
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Difficult recruitment, despite several interventions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart van den Bemt, PharmD, PhD principal investigator
Radboudumc/ Sint Maartenskliniek
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administration of medication (SAM) in people with Medication Safety and Patient Safety, run by Radboud University Medical Center at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult recruitment, despite several interventions.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of medication administration errors (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.