- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06731387
Assessing the Role of Pharmaceutical Technical Assistents in Hospital Wards: Measuring Efficiency and Medication Safety
Impact of Implementing Pharmaceutical Technical Assistants to Support the Medication Process in Hospital Wards: Effects on Operational Efficiency and Medication Safety
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brecht Seraes, Doctor
- Phone Number: +3237602039
- Email: brecht.serraes@vitaz.be
Study Contact Backup
- Name: Marjan De Graef
- Phone Number: +3237602038
- Email: marjan.degraef@vitaz.be
Study Locations
-
-
Oost-Vlaanderen
-
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
- VITAZ
-
Contact:
- Brecht Serraes, Doctor
- Phone Number: +327602039
- Email: brecht.serraes@vitaz.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for observed medication dispensation moments
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.
Exclusion Criteria: Hospital wards that introduced the involvement of PTAs less than six months ago.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PTAs dispensing medications
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time spent on medication dispensation on the hospital ward
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dispensing errors
Time Frame: 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.
|
Intervention Period: Verifying the accuracy of medication dispensed by the PTA, including recording the number and type of errors identified. Control Period: Verifying the accuracy of medication dispensed by the night nurse, including recording the number and type of errors identified. |
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
Time Frame: 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.
|
Intervention Period: Reviewing the electronic medication system for the day the PTA prepared the medication. This includes recording the number of delayed or missed doses, the name and type of medication involved, and the reasons for the delay or non-administration. Control Period: Reviewing the electronic medication system for the day the night nurse dispensed the medication. This includes recording the number of delayed or missed doses, the name and type of medication involved, and the reasons for the delay or non-administration. |
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
Time Frame: 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.
|
Collecting the reported medication errors from the hospital's incident reporting system during both the intervention and control periods.
|
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
Time Frame: 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.
|
The exchange of information and updates between the pharmacy and the hospital ward to ensure accurate medication preparation, timely delivery, and proper administration.
During both the intervention and control periods, this communication includes coordinating medication orders, addressing discrepancies, managing urgent requests, and providing guidance or clarifications as required.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tinne Dilles, Doctor, Professor, Universiteit Antwerpen
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EC24018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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