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

NCT03728855 | Terminated

• 1 other identifier: UMCN-AKF-18.02
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 8

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.

Conditions

Medication Safety; Patient Safety; Patient Empowerment

Keywords

Self-administration of medication; SAM; Medication Safety; Patient Empowerment; Patient Satisfaction; Staff Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Severity of MAEs

  2 weeks

• Medication adherence after hospitalization

  3 months

• Medication adherence after hospitalization

  1 year

• Patient satisfaction during hospitalization

  7 days

• Patient satisfaction during hospitalization

  7 days

Study Arms (2)

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.

Behavioral: Self-administration of medication (SAM)

Interventions

Self-administration of medication (SAM) BEHAVIORAL

Patients use medication from their own stock, self-administered.

Self-administration of medication (SAM)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (8)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

Location

MUMC+

Maastricht, Limburg, 6229 HX, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

ETZ

Tilburg, North Brabant, 5042 AD, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, South Holland, 2803 HH, Netherlands

Location

Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands

Location

MeSH Terms

Conditions

Patient Participation; Patient Satisfaction

Interventions

Self Administration

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Self Care

Study Officials

• Bart van den Bemt, PharmD, PhD

  Radboudumc/ Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention of this study is the implementation of self-administration of medication (SAM) by hospitalized patients. SAM will be compared to standard care.

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: November 2, 2018
• Study Start: December 1, 2018
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

NL (8)