Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03728855
Other study ID # UMCN-AKF-18.02
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date May 2, 2019

Study information

Verified date September 2020
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 193
Est. completion date May 2, 2019
Est. primary completion date May 2, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-administration of medication (SAM)
Patients use medication from their own stock, self-administered.

Locations

Country Name City State
Netherlands Jeroen Bosch Ziekenhuis 's-Hertogenbosch Noord-Brabant
Netherlands Meander Medisch Centrum Amersfoort
Netherlands Catharina Ziekenhuis Eindhoven Noord-Brabant
Netherlands Groene Hart Ziekenhuis Gouda Zuid-Holland
Netherlands MUMC+ Maastricht Limburg
Netherlands Radboudumc Nijmegen Gelderland
Netherlands ETZ Tilburg Noord-Brabant
Netherlands Sint Maartenskliniek Ubbergen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 2 weeks
Secondary 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. 2 weeks
Secondary 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. 3 months
Secondary 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
1 year
Secondary Patient satisfaction during hospitalization Patient satisfaction will be measured by the visual analogue scale (VAS) for patient satisfaction. 7 days
Secondary Patient satisfaction during hospitalization Patient satisfaction will be measured by the Beliefs about Medicine Questionnaire (BMQ). 7 days
Secondary 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. 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06043895 - EpiFaith CV for Central Venous Catheterization N/A
Not yet recruiting NCT05958108 - Effectivenness and Implementation of an Intervention to Improve Primary Care Patient Safety Phase 3
Recruiting NCT02574104 - Generalizing TESTPILOT to New Single Family Room NICUs N/A
Completed NCT00599209 - Health Information Technology in the Nursing Home N/A
Completed NCT04576299 - Health Care Workers' Perception of Patient Safety During COVID-19 Pandemic
Completed NCT03663491 - Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis N/A
Completed NCT00212927 - Continuity of Care and Outcomes After Discharge From Hospital N/A
Not yet recruiting NCT05062434 - An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans N/A
Recruiting NCT06089239 - De-Implementing Fall Prevention Alarms in Hospitals N/A
Recruiting NCT04861025 - Siderails as a Measure of Physical Restraint. GERBAR Trial
Completed NCT04990986 - Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes N/A
Recruiting NCT02955836 - Effectiveness of Monitoring Information System of Nursing Related Patient Safety and Quality Indicators N/A
Completed NCT01246544 - Helsinki Declaration on Patient Safety N/A
Recruiting NCT05530187 - ePRO-based Model of Care to Manage and Monitoring Symptoms of Cancer Patients Treated With Immune Checkpoint Inhibitors N/A
Recruiting NCT04176094 - Intensive Care Unit Resident Scheduling Trial N/A
Completed NCT05794490 - Learning From Excellence in a Hospital Unit
Recruiting NCT06269250 - Acceptance and Perceived Benefits of Digitalization by Medical Assistants
Recruiting NCT03105713 - Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery N/A
Completed NCT04184570 - Audit of International Intraoperative Hemotherapy and Blood Loss Documentation
Recruiting NCT04897087 - Openness and Learning Joint Commission: Using Patient Experience for Improvement Following a Patient Safety Event