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.

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.