Effectiveness of Faith-Based Interventions on the Rate of Discharged Against Medical Advice in Tertiary Newborn Units in Nigeria: A Protocol for an Open Label Randomized Control Trial

Abstract

BackgroundDischarged against medical advice (DAMA) is a risk factor that often leads to adverse outcomes and hospital readmissions in neonatal units. A few studies have shown that spiritual/faith-based interventions (FBIs) tend to have a lower incidence of DAMA compared with public hospitals. Perhaps, a holistic approach to patient care that addresses the spiritual needs, the soul and the body component of a being in this setting may account for the observed lower incidence of DAMA. Limited randomized control trials (RCTs) exist on FBIs with regard to DAMA in the published literature. This study seeks to compare the effectiveness of FBI, social support, religiosity, and types of FBI on neonatal DAMA against standard of care in tertiary hospitals in Nigeria.MethodsThis RCT will be conducted in two public tertiary teaching hospitals in two of the six geopolitical zones in Nigeria. The sociodemographic and clinical details of all patients admitted to the neonatal wards during the study period will be documented. Study participants will be selected through a multistage sampling technique. Subjects will be randomized and allocated to treatment and control arms having the established baseline measure of social support and religiosity. Ethical approval was obtained from the State Research Ethics Review Committee. A written informed consent will be obtained from the parents/caregivers prior to patient enrolment. The study will be conducted in line with the Declaration of Hesinki 2000. Appropriate statistical tools will be used for data collection and analysis.DiscussionThe outcome of this analysis will give insights into the effectiveness of FBI on DAMA. It will also predict the effect of the mediators of parents/caregivers' religiosity, spirituality, forms of FBI, the religious sect of parents/caregivers, and social support on the rate of DAMA on neonatal admission in tertiary hospitals in Nigeria. This could help Public Health Institutions and Governments make decisions about the determinants of neonatal DAMA and how to mitigate such outcomes. It is hoped that the evidence from this study may guide policy formulation and guidelines on enhancing hospital retention of sick neonates until they are fit for discharge.Trial RegistrationThis study was registered at the Pan Africa Clinical Trial Registry (PACTR202102670906630).