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Difficult recruitment, despite several interventions.
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administration of medication (SAM) | Behavioral | Patients use medication from their own stock, self-administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bart van den Bemt, PharmD, PhD | Radboudumc/ Sint Maartenskliniek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525 GA | Netherlands | ||
| Sint Maartenskliniek |
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The intervention of this study is the implementation of self-administration of medication (SAM) by hospitalized patients. SAM will be compared to standard care.
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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.
| 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 |
| 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 |
| Patient satisfaction during hospitalization | Patient satisfaction will be measured by the visual analogue scale (VAS) for patient satisfaction. | 7 days |
| Patient satisfaction during hospitalization | Patient satisfaction will be measured by the Beliefs about Medicine Questionnaire (BMQ). | 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. | 1 year |
| Ubbergen |
| Gelderland |
| 6574 NA |
| Netherlands |
| MUMC+ | Maastricht | Limburg | 6229 HX | Netherlands |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | North Brabant | 5223 GZ | Netherlands |
| Catharina Ziekenhuis | Eindhoven | North Brabant | 5623 EJ | Netherlands |
| ETZ | Tilburg | North Brabant | 5042 AD | Netherlands |
| Groene Hart Ziekenhuis | Gouda | South Holland | 2803 HH | Netherlands |
| Meander Medisch Centrum | Amersfoort | 3813 TZ | Netherlands |
| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012646 | Self Administration |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012648 | Self Care |
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