Cluster-randomized trial of the implementation of the Responses to Illness Severity Quantification (RISQ) system in children with acute malnutrition 6 to 59 months of age in Ngouri, Chad: the CRIMSON trial protocol

Abstract

Background: The Responses to Illness Severity Quantification (RISQ) System is a scientifically developed clinical decision support tool comprised of four parts: (1) a validated 7-item severity of illness score, (2) age-specific documentation forms, (3) context-relevant score-matched recommendations, and (4) implementation programming. Care recommendations, expertly derived from a panel of clinicians extensively experienced in humanitarian contexts, include frequency of observation, consideration of secondary review, inpatient admission, and transfer into/out of advanced inpatient care areas. The RISQ System is to be used as an adjunct to current care practice to aid clinicians in clinical decision-making. The objective of the CRIMSON study is to estimate the effect of implementation of the RISQ System on mortality and processes of care in a nutritional program.

Methods: A cluster randomized trial will compare the RISQ System to usual care. Eligible clusters are community health centers that enroll patients into the Ministry of Health/ALIMA OptiMA acute malnutrition program in the Ngouri district of Chad. Eligible patients are aged 6-59 months with mid-upper arm circumference (MUAC) < 125 mm and/or edema. Participating centers will be allocated in a 1:1 ratio to usual care or the RISQ System. The primary outcome is mortality to the earlier of 60 days after program entry or program discharge. A 14-month baseline period will precede a 14-month intervention period. With a sample of 20,000 patients in 34 centers (assuming an intraclass correlation coefficient of 0.0005, equal-sized clusters, and 1.5% baseline mortality) provides 80% power to detect a 0.5% absolute decrease in mortality using a one-sided alpha of 0.05. Bayesian logistic regression will be used in analyses of the primary outcome.

Discussion: This cluster randomized evaluation of the RISQ System will estimate effect on program mortality as well as provide detailed information on the implementation of a clinical decision support tool in a low-resource humanitarian setting. Improving the precision of clinical determinations about hospitalization could potentially reduce mortality by 30% within nutrition treatment programs.

Trial registration: ClinicalTrials.gov NCT06123390 . First posted date: 2023-11-08.

Keywords: Malnutrition; Mortality; Score; Severity of illness.