Clinical trial NCT06123390: Evaluating RISQ System Implementation in Acutely Malnourished Children in Chad (CRIMSON)
Official title: Cluster-Randomized Trial of the Implementation of the Responses to Illness Severity Quantification System (RISQ) in Children With Acute Malnutrition Six to Fifty-nine Months of Age in Ngouri, Chad
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Acute Malnutrition
Keywords: decision support
mortality
illness severity
risk score
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Alliance for International Medical Action
name: University of N'Djaména, Chad
First posted: 2023-11-08
Enrollment: 20000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study we are evaluating usual care (Arm 1) vs. the Responses to Illness Severity Quantification (Arm 2) in children children aged 6 to 59 months who are enrolled in the OptiMA nutrition program in Chad.

Community health centres will be the randomized clusters.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of the Responses to Illness Severity Quantification (RISQ) system implementation on mortality and processes of care in a nutritional program treating children 6 to 59 months of age with acute malnutrition in Ngouri, Chad.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Children:

1. age: 6 to 59 months at enrolment on the day of their admission/re-admission to the OptiMA program
2. written consent to participate

Front line staff providing care to patients enrolled in the Optima program:

\[1\] Registered Nurses \[2\] Medical Doctors

Exclusion Criteria:

Children:

1. Children allergic to milk, peanuts and/or ready-to-use therapeutic food (RUTF)
2. Children not residing in one of the study areas.

Primary outcomes:
measure: All-cause mortality.
timeFrame: 12 months
Secondary outcomes:
measure: Timing of inpatient mortality
timeFrame: Duration of hospitalization in days up to 60 days
measure: Timing of outpatient mortality
timeFrame: Duration of program inclusion in days up to 60 days
measure: Therapeutic intensity
timeFrame: First 24 hours from admission to hospital
measure: Efficiency of inpatient care
timeFrame: Duration of hospitalization in days up to 60 days
measure: Workload
timeFrame: Month 1 and month 12
measure: Knowledge
timeFrame: Month 1 and month 12
measure: Fidelity of RISQ Implementation
timeFrame: 12 months
measure: Acceptability
timeFrame: Month 1 and month 12
Other outcomes:
measure: Lived experience of RISQ System implementation
timeFrame: one time at end of 12 month implementation period
measure: comparison of automated versus manual measurements of vital signs (Respiratory rate in breaths/min)
timeFrame: During run-in phase prior to implementation of intervention, on average 2 months
measure: comparison of automated versus manual measurements of vital signs (Temperature in degrees Celsius)
timeFrame: During run-in phase prior to implementation of intervention, on average 2 months
measure: Comparison of RISQ scores among children with different clinical conditions in inpatient care
timeFrame: Duration of hospitalization in days up to 60 days
Locations:
city: Ngouri
country: Chad
facility: Ngouri
Study officials:
affiliation: The Hospital for Sick Children
name: Christopher Parshuram, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dale NM, Ashir GM, Maryah LB, Shepherd S, Tomlinson G, Briend A, Zlotkin S, Parshuram C. Development and an initial validation of the Responses to Illness Severity Quantification (RISQ) score for severely malnourished children. Acta Paediatr. 2022 Sep;111(9):1752-1763. doi: 10.1111/apa.16410. Epub 2022 Jun 3.
citation: Dale NM, Ashir GM, Maryah LB, Shepherd S, Tomlinson G, Briend A, Zlotkin S, Parshuram CS. Evaluating the Validity of the Responses to Illness Severity Quantification Score to Discriminate Illness Severity and Level of Care Transitions in Hospitalized Children with Severe Acute Malnutrition. J Pediatr. 2023 Nov;262:113609. doi: 10.1016/j.jpeds.2023.113609. Epub 2023 Jul 5.