The CRIMSON Study is a 12-month cluster randomized trial that will evaluate the effect of
implementing the RISQ system compared with usual care on all-cause mortality, in children
with acute malnutrition aged 6 to 59 months enrolled in the OptiMA nutrition program in Chad.
The intervention is the RISQ System and the clusters are the individual health centres that
are randomized with a ratio of 1:1, RISQ System: Usual care. The 12 month intervention period
will begin following a run in phase in which sites randomized to intervention will introduce
and establish the new practices and in which sites randomized to usual care will continue to
provide usual care.
The RISQ system is a scientifically developed clinical decision support tool that consists
of: [1] the RISQ score; [2] documentation form; [3] score-matched recommendations and [4] an
implementation package. The RISQ score, developed through our prospective observational study
in Maiduguri Nigeria ((NCT04582773) ranges from 0 to 26 (high scores indicating greatest
severity of illness). In the development dataset, the mean RISQ score on admission was 3.6 in
hospital survivors and 7.3 for children dying <48hr of admission. RISQ scores <24hr before
death had Area Under the Receiver Operating Characteristics Curve (AUROC) of 0.93. The RISQ
score performed similarly well in children independent of their clinical conditions as a
diagnosis-independent measure of severity of illness. Additionally, through a study of 903
hospitalized children with Severe Acute Malnutrition (SAM), the RISQ score could discriminate
between points of escalation or de-escalation of care and can reflect illness severity in
children throughout hospitalization. The documentation form provides visual representation of
the sub-scores of each RISQ score items and guidance for score calculation. The score-matched
recommendations of the RISQ system that are linked to the RISQ scores are derived from an
expert panel of clinicians, with over 100 years of collective experience caring for acutely
malnourished children, and provide guidance about intensity of care. This includes the
frequency of observation, consideration of secondary review, inpatient admission, and
transfer into / out of inpatient care areas where more intensive treatments are provided.The
implementation package consists of theoretical and practical training modules including
specific 'train the trainers' sessions for key personal involved in the implementing
programs.
The CRIMSON study is nested within the existing framework of the OptiMA nutritional program
and observational study conducted by the Alliance for International Medical Action (ALIMA).
The program involves health centres within Ngouri, a sub-prefecture of the Lake Region in
Chad (and surrounding area) plus an inpatient unit at the Ngouri District Hospital providing
care for children with acute malnutrition. Inclusion criteria for the OptiMA program are
based on mid-upper arm circumference (MUAC) of <125mm and/or bilateral pitting oedema. Usual
care in the OptiMA program is as follows: nutritional treatment to participants consists of
Ready-to-use-Therapeutic Food (RUTF) adjusted based on their MUAC value throughout the
duration of their care. Management of the children with acute illnesses follows the
established approach for management of children with severe acute malnutrition using the
World Health Organization (WHO) "danger signs" and Integrated Management of Childhood Illness
(IMCI) algorithms to guide admission to hospital. Additionally, as part of the OptiMA program
in Ngouri, pulse oximeters have been introduced in all health centres and inpatient care
unit, following training by ALIMA. Included in the routine visits of the program is the
measurement and documentation of each of the 7 RISQ score items [heart rate, respiratory
rate, respiratory effort, oxygen saturation, temperature, level of consciousness and oxygen
use (oxygen is currently only available in the inpatient care)] by nurses.
The investigators anticipate that implementation of the RISQ system in a nutrition treatment
program will improve sensitivity and specificity of clinical evaluation in determining which
children require hospitalization, and what level of medical care within the in-patient unit
is appropriate and in turn potentially reduce mortality.