Medication SafetyNCT06731387
Assessing the Role of Pharmaceutical Technical Assistents in Hospital Wards: Measuring Efficiency and Medication Safety
A study testing Pharmaceutical technical assistants supported medication dispensation on the hospital ward in people with Medication Safety and Time Efficiency, run by Vitaz at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Safety, Time Efficiency, Interdepartmental Communication
- What is being tested?
- Pharmaceutical technical assistants supported medication dispensation on the hospital ward
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
- Being tested
- Pharmaceutical technical assistants supported medication dispensation on the hospital ward
- Keywords
- pharmacy assistants, medication safety, hospital ward, medication management, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical technical assistants supported medication dispensation on the hospital wardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PTAs dispensing medications | Experimental | Not described Receives: Other: Pharmaceutical technical assistants supported medication dispensation on the hospital ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Collecting the reported medication errors from the hospital's incident reporting system during both the intervention and control periods.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Dec 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaz
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Applied Sciences Utrecht
- Responsible party
- Sponsor
- Investigators
- Tinne Dilles, Doctor, Professor, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731387
- Sponsor's protocol ID
- EC24018
- Status last verified
- Jul 2026
- First submitted
- 2 Dec 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32133133Kjeldsen 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.
PubMed 37218964
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implementing Pharmaceutical Technical Assistants to Support the Medication Process in Hospital Wards: Effects on Operational Efficiency and Medication Safety
- ClinicalTrials.gov ID
- NCT06731387
- Acronym / sponsor ID
- EC24018
- Keywords
- pharmacy assistants, medication safety, hospital ward, medication management, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- VitazUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Applied Sciences Utrecht
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PTAs dispensing medications | Experimental | Other: Pharmaceutical technical assistants supported medication dispensation on the hospital ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical technical assistants supported medication dispensation on the hospital wardPharmaceutical 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. | Other | PTAs dispensing medications |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 32133133Rathbone 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.
- Background: PubMed 37218964Kjeldsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tinne Dilles, Doctor, Professor principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical technical assistants supported medication dispensation on the hospital ward in people with Medication Safety and Time Efficiency, run by Vitaz at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06731387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.