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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728855
Recruitment Status : Terminated (Difficult recruitment, despite several interventions.)
First Posted : November 2, 2018
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Medication Safety Patient Safety Patient Empowerment Behavioral: Self-administration of medication (SAM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: The subject, staff and investigators are aware of which method of medication administration the patient is given, SAM or standard care. Only the data analysis is blinded by anonymizing and coding all data. Furthermore, an independent person will perform the data analyses.
Primary Purpose: Health Services Research
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
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : May 2, 2019
Actual Study Completion Date : May 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Behavioral: Self-administration of medication (SAM)
Patients use medication from their own stock, self-administered.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Severity of MAEs [ Time Frame: 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.

  2. Medication adherence after hospitalization [ Time Frame: 3 months ]
    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. Medication adherence after hospitalization [ Time Frame: 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


  4. Patient satisfaction during hospitalization [ Time Frame: 7 days ]
    Patient satisfaction will be measured by the visual analogue scale (VAS) for patient satisfaction.

  5. Patient satisfaction during hospitalization [ Time Frame: 7 days ]
    Patient satisfaction will be measured by the Beliefs about Medicine Questionnaire (BMQ).

  6. Staff satisfaction [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728855


Locations
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Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Sint Maartenskliniek
Ubbergen, Gelderland, Netherlands, 6574 NA
MUMC+
Maastricht, Limburg, Netherlands, 6229 HX
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Noord-Brabant, Netherlands, 5223 GZ
Catharina Ziekenhuis
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
ETZ
Tilburg, Noord-Brabant, Netherlands, 5042 AD
Groene Hart Ziekenhuis
Gouda, Zuid-Holland, Netherlands, 2803 HH
Meander Medisch Centrum
Amersfoort, Netherlands, 3813 TZ
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Bart van den Bemt, PharmD, PhD Radboudumc/ Sint Maartenskliniek
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03728855    
Other Study ID Numbers: UMCN-AKF-18.02
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Self-administration of medication
SAM
Medication Safety
Patient Empowerment
Patient Satisfaction
Staff Satisfaction