Impact of pharmaceutical validation on prescribing errors in a Neonatal Intensive Care Unit.
| ISRCTN | ISRCTN12370877 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12370877 |
| Secondary identifying numbers | 21/365 |
- Submission date
- 18/11/2023
- Registration date
- 21/11/2023
- Last edited
- 21/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Patients admitted to Neonatal Intensive Care Units (NICU) are up to eight times more at risk of medication errors than patients admitted to adult Intensive Care Units. Prescribing errors account for up to 74% of medication errors. Because of this, we have designed a project to improve the quality of care in order to reduce the number of prescription errors that reach the patient.
Who can participate?
This study is open to all newborns admitted to the intensive care unit.
What does the study involve?
We have designed a study to improve the quality of care in order to reduce medication errors in neonatal patients admitted to the intensive care unit. During this study, a clinical pharmacist will carry out a review of the treatments prescribed in the electronic prescription prior to the administration of the medication.
What are the possible benefits and risks of participating?
As this is a quality improvement project, patients can benefit from the improvement that a review of their treatment by a pharmacist can bring, without any risk.
Where is the study run from?
Hospital 12 de Octubre (Spain)
When is the study starting and how long is it expected to run for?
June 2021 to December 2022
Who is funding the study?
Hospital 12 de Octubre (Spain)
Who is the main contact?
Maria Dolores Canales, mcanales@salud.madrid.org
Contact information
Public, Scientific, Principal Investigator
Calle de Salvador Allende, 34C
4b
Madrid
28054
Spain
 ORCID ID |
0000-0003-1192-2855 |
|---|---|
| Phone | +34 675091692 |
| mcanales@salud.madrid.org |
Study information
| Study design | Prospective randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety |
| Participant information sheet | No participant information sheet available |
| Scientific title | Impact of pharmaceutical validation on prescribing errors in a Neonatal Intensive Care Unit. Randomised and controlled study. |
| Study hypothesis | Pharmaceutical validation of medical prescriptions reduces medication errors reaching patients admitted to neonatal intensive care units |
| Ethics approval(s) |
Approved 26/10/2021, Comité de Ética de la Investigación con medicamentos del Hospital Universitario 12 de Octubre (AV Cordoba SN, Madrid, 28054, Spain; +34 91 779 26 13; ceicdoc@h12o.es), ref: 21/365 |
| Condition | Prevention of medical errors in newborns |
| Intervention | During the randomised phase, patients were assigned to the intervention or the control group at admission according to a simple randomisation using a web-based system (www.dcode.fr). Pharmaceutical validation of treatments was performed on a daily basis in the same way as in the pre-intervention phase for patients in the intervention group. For patients included in the control group, treatments were retrospectively reviewed at discharge from the NICU by the same pharmacist. For all arms of the study, the follow-up time is for the duration of the patient's admission. |
| Intervention type | Behavioural |
| Primary outcome measure | Percentage of prescription errors detected by a clinical pharmacist in e-prescribing measured at the end of the study |
| Secondary outcome measures | Percentage of prescribing errors reaching the patient according to the nursing administration record measured at the end of the study |
| Overall study start date | 06/06/2021 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 0 Days |
| Sex | Both |
| Target number of participants | 164 |
| Total final enrolment | 240 |
| Participant inclusion criteria | All patients born during the study period who were admitted to the NICU and stayed for at least 24 hours and with active pharmacological treatment |
| Participant exclusion criteria | Patients admitted without pharmacological treatment or less than 24h. |
| Recruitment start date | 01/09/2021 |
| Recruitment end date | 30/06/2022 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28041
Spain
Sponsor information
Hospital/treatment centre
Av. Cordoba SN
Madrid
28041
Spain
| Phone | +34 913908000 |
|---|---|
| farmacia.hdoc@salud.madrid.org | |
| Website | https://www.comunidad.madrid/hospital/12octubre/ |
"ROR" |
https://ror.org/00qyh5r35 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
21/11/2023: Trial's existence confirmed by Comité de Ética de la Investigación con medicamentos del Hospital Universitario 12 de Octubre.
