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Trial no.:
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PACTR202203869312307 |
Date of Approval:
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17/03/2022 |
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Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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| TRIAL DESCRIPTION |
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Public title
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A study to improve Gentamicin antibiotic prescription accuracy during hospital care for sick new-born babies in Kenya over time using feedback given to clinicians |
| Official scientific title |
Evaluation of an audit and feedback intervention to Reduce Gentamicin Prescription Errors in Newborn Treatment (ReGENT) in neonatal inpatient care in Kenya: A controlled interrupted time series study protocol |
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Brief summary describing the background
and objectives of the trial
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Medication errors are likely common in low- and middle- income countries (LMICs). In neonatal (i.e., first 28 days of life) hospital care where the population with severe illness has a high mortality rate around 14.9% of drug prescriptions have errors in LMIC settings. However, there is scant research on interventions to improve medication safety to mitigate such errors.
Our objective is to improve routine neonatal care particularly focusing on effective prescribing practices with the aim of achieving reduced gentamicin prescribing errors. This study uses audit and feedback (A&F) intervention that proposes to introduce two forms of enhanced feedback to health workers providing care to neonatal admissions in 20 hospitals that are part of a Clinical Information Network (CIN) to reduce Gentamicin prescription errors. The study will use an interrupted time series design, with data collected for 12 months before and after introduction of enhanced feedback forming the pre-intervention and post-intervention phases respectively.
Key objectives are:
(1) To evaluate if enhancing A&F intervention approaches over and above existing use of feedback reports reduces the prevalence of gentamicin prescribing errors (measured as an incidence rate ratio) in neonatal inpatient hospital care over time,
(2) To evaluate if an A&F package incorporating more Clinical Performance Feedback Intervention Theory (CP-FIT) components (which is hypothesised to be likely highly effective across facilities) is more effective in reducing gentamicin prescribing errors in inpatient neonatal care compared to an A&F package incorporating few CP-FIT informed components (which is hypothesised to be likely highly scalable across facilities), and
(3) To explore the value of the CP-FIT model as a guiding framework for designing and helping understand the results of a prospective behaviour change implementation strategy employing A&F in Kenyan clinical settings |
| Type of trial |
RCT |
| Acronym (If the trial has an acronym then please provide) |
ReGENT |
| Disease(s) or condition(s) being studied |
Neonatal care prescribing practices |
| Sub-Disease(s) or condition(s) being studied |
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| Purpose of the trial |
Behavioural intervention on prescribing practices |
| Anticipated trial start date |
01/05/2022 |
| Actual trial start date |
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| Anticipated date of last follow up |
30/04/2023 |
| Actual Last follow-up date |
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| Anticipated target sample size (number of participants) |
8280 |
| Actual target sample size (number of participants) |
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| Recruitment status |
Active, not recruiting |
| Publication URL |
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