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
Authors: Tuti Timothy , Aluvaala Jalemba , Malla Lucas , Irimu Grace , Mbevi George , Wainaina John , Mumelo Livingstone , Wairoto Kefa , Mochache Dolphine , Hagel Christiane , Maina Michuki , English Mike ,   on behalf of The Clinical Information Network Group, Vitalis Juma , Bonface Nyumbile , Malangachi Roselyne , Manyasi Christine , Mutinda Catherine , Kimutai David Kibiwott , Aden Rukia , Emadau Caren , Jowi Elizabeth Atieno , Muithya Cecilia , Nzioki Charles , Tunje Supa , Musyoka Penina , Mwangi Wagura , Mithamo Agnes , Kuria Magdalene , Njiru Esther , Ngina Mwangi , Mwangi Penina , Inginia Rachel , Musabi Melab , Namulala Emma , Ochieng Grace , Thuranira Lydia , Makokha Felicitas , Ojigo Josephine , Maina Beth , Waiyego Mary , Lusweti Bernadette , Ithondeka Angeline , Barasa Julie , Liru Meshack , Kibaru Elizabeth , Nyaribari Alice Nkirote , Akuka Joyce , Wangari Joyce , Ngoda Amilia , Emenwa Aggrey Nzavaye , Wesakania Patricia Nafula , Lipesa George , Mbungu Jane , Mutenyo Marystella , Mbogho Joyce , Baswetty Joan , Jambi Ann , Aritho Josephine , Njambi Beatrice , Mucheke Felisters , Kioni Zainab , Jeniffer  , Kinyua Lucy , Kethi Margaret , Oguda Alice , Situma Salome Nashimiyu , Gachaja Nancy , Mwangi Loise N. , Mwai Ruth , Muruga Irginia Wangari , Mburu Nancy , Muteshi Celestine , Bwire Abigael , Muyale Salome Okisa , Situma Naomi , Mueni Faith , Mwaura Hellen , Mututa Rosemary , Lavu Caroline , Oketch Joyce , Olum Jane Hore , Nyakina Orina , Njeru Faith , Chelimo Rebecca , Mwaura Margaret Wanjiku , Wambugu Ann , Mburu Epharus Njeri , Tindi Linda Awino , Akumu Jane , Otieno Ruth , Osok Slessor , Kulubi Seline , Wanjala Susan , Njeru Pauline , Mbogo Rebbecca Mukami , Ollongo John , Soita Samuel , Mirenja Judith , Nguri Mary , Waweru Margaret , Oruko Mary Akoth , Kuya Jeska , Muthuri Caroline , Muthiani Esther , Mwangi Esther , Nganga Joseph , Tanui Benjamin , Wanjau Alfred , Onsongo Judith , Muigai Peter , Namayi Arnest , Kosiom Elizabeth , Cherop Dorcas , Marete Faith , Simiyu Johanness , Danga Collince , Oyugi Arthur Otieno , Okoth Fredrick Keya 
Published: May 2022

Abstract
Background
Medication errors are likely common in low- and middle-income countries (LMICs). In neonatal hospital care where the population with severe illness has a high mortality rate, around 14.9% of drug prescriptions have errors in LMICs 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 medication errors.

Methods
We propose to conduct an audit and feedback (A&F) study over 12 months in 20 hospitals with 12 months of baseline data. The medical and nursing leaders on their newborn units had been organised into a network that facilitates evaluating intervention approaches for improving quality of neonatal care in these hospitals and are receiving basic feedback generated from the baseline data. In this study, the network will (1) be expanded to include all hospital pharmacists, (2) include a pharmacist-only professional WhatsApp discussion group for discussing prescription practices, and (3) support all hospitals to facilitate pharmacist-led continuous medical education seminars on prescription practices at hospital level, i.e. default intervention package. A subset of these hospitals (n = 10) will additionally (1) have an additional hospital-specific WhatsApp group for the pharmacists to discuss local performance with their local clinical team, (2) receive detailed A&F prescription error reports delivered through mobile-based dashboard, and (3) receive a PDF infographic summarising prescribing performance circulated to the clinicians through the hospital-specific WhatsApp group, i.e. an extended package.
Using interrupted time series analysis modelling changes in prescribing errors over time, coupled with process fidelity evaluation, and WhatsApp sentiment analysis, we will evaluate the success with which the A&F interventions are delivered, received, and acted upon to reduce prescribing error while exploring the extended package’s success/failure relative to the default intervention package.

Discussion
If effective, these theory-informed A&F strategies that carefully consider the challenges of LMICs settings will support the improvement of medication prescribing practices with the insights gained adapted for other clinical behavioural targets of a similar nature.

Trial registration
PACTR, PACTR202203869312307. Registered 17th March 2022.