NCT06731387

Brief Summary

The goal of this interventional study is to evaluate the impact of implementing pharmaceutical technical assistants (PTAs) to support the medication process on hospital wards on operational efficiency and medication safety among nurses and pharmaceutical technicial assistants. The main questions it aims to answer are:

  • What is the effect of PTAs on the time spent by (night) nurses on medication dispensation?
  • How does their involvement influence unplanned interactions between nursing staff and the pharmacy?
  • What is the impact of PTAs on the safety of medication processes, including missed or delayed doses, accuracy of dispensed medication, and reported medication errors? Researchers will compare periods with and without the involvement of PTAs in the medication management process on the hospital ward to assess differences in:
  • Time spent on medication dispensation.
  • Frequency of unplanned interactions between hospital wards and the pharmacy.
  • Rates of missed or delayed medication doses.
  • Accuracy of dispensed medication compared to prescriptions.
  • Reported medication errors. During the observed medication dispensation processes, involved nurses and PTAs will:
  • Be observed while preparing medications to measure time and interruptions.
  • Provide data on medication errors and delays through digital systems and reports.
  • Complete a demographic questionnaire about their professional background. This study involves both intervention and control periods, allowing researchers to measure the specific effects of PTAs' involvement in medication processes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 2, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

pharmacy assistantsmedication safetyhospital wardmedication managementnursing

Outcome Measures

Primary Outcomes (1)

  • Time spent on medication dispensation on the hospital ward

    Intervention Period: Observing and recording the time the Pharmaceutical Technical Assistant (PTA) spends dispensing medication on the hospital ward. This is followed by observing and recording the time the night nurse takes to complete the medication dispensation for the next day. Control Period: Observing and recording the time the night nurse spends dispensing medication for the next day without PTA involvement.

    Data collection was conducted over five days during the control period and five days during the intervention period on each of the included hospital wards.

Secondary Outcomes (4)

  • Dispensing errors

    Data collection was conducted over five days during the control period and five days during the intervention period on each of the included hospital wards.

  • Delayed and omitted medication doses

    Data collection was conducted over five days during the control period and five days during the intervention period on each of the included hospital wards.

  • Reported Medication Errors

    Data collection was conducted over five days during the control period and five days during the intervention period on each of the included hospital wards.

  • Interdepartmental Communication Between Pharmacy and Hospital Ward

    Data collection was conducted over five days during the control period and five days during the intervention period on each of the included hospital wards.

Study Arms (1)

PTAs dispensing medications

EXPERIMENTAL
Other: Pharmaceutical technical assistants supported medication dispensation on the hospital ward

Interventions

Pharmaceutical technical assistants (PTAs) visit the hospital ward for two hours in the morning or afternoon to dispense medications for admitted patients for the following day. Night nurses then complete any final additions or adjustments as needed.

PTAs dispensing medications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Control Period:
  • Medication dispensation moments must be performed by nurses during the nightshift. .
  • Nurses included must have at least six months of experience working night shifts.
  • Intervention Period:
  • Medication dispensation moments must be performed by PTAs.
  • PTAs included must have at least six months of experience specifically in medication dispensation tasks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitaz

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

Related Publications (2)

  • Rathbone AP, Jamie K, Blackburn J, Gray W, Baqir W, Henderson E, Campbell D. Exploring an extended role for pharmacy assistants on inpatient wards in UK hospitals: using mixed methods to develop the role of medicines assistants. Eur J Hosp Pharm. 2020 Mar;27(2):78-83. doi: 10.1136/ejhpharm-2018-001518. Epub 2018 Sep 3.

    PMID: 32133133BACKGROUND
  • Kjeldsen LJ, Schlunsen M, Meijers A, Hansen S, Christensen C, Bender T, Ratajczyk B. Medication Dispensing by Pharmacy Technicians Improves Efficiency and Patient Safety at a Geriatric Ward at a Danish Hospital: A Pilot Study. Pharmacy (Basel). 2023 May 8;11(3):82. doi: 10.3390/pharmacy11030082.

    PMID: 37218964BACKGROUND

Study Officials

  • Tinne Dilles, Doctor, Professor

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brecht Seraes, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This study focuses on analyzing 50 medication dispensation processes on hospital wards, evenly distributed across two distinct periods: a control period without the involvement of Pharmaceutical Technical Assistants (PTAs) (medication dispensation by the night nurses) and an intervention period where PTAs actively participate in medication dispensation. Nurses and PTAs observed during the dispensation processes will be included in the study based on the selected medication dispensation moments during which they are on duty.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 12, 2024

Study Start

December 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations