Evaluating RISQ System Implementation in Acutely Malnourished Children in Chad (CRIMSON)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Severe Acute Malnutrition

Intervention / Treatment
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* Other: The Responses to Illness Severity Quantification (RISQ) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children: age: 6 to 59 months at enrolment on the day of their admission/re-admission to the OptiMA program 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: Children allergic to milk, peanuts and/or ready-to-use therapeutic food (RUTF) Children not residing in one of the study areas.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>The 17 health centres randomized to Usual Care will provide care as per OptiMA program. | |
| Experimental: Intervention Arm<br>The 17 health centres randomized to the intervention arm will provide care as per OptiMA program with the addition of the RISQ System decision support. | Other: The Responses to Illness Severity Quantification (RISQ) System<br>* The RISQ System involves: [1] the RISQ score: calculated routinely using the [2] documentation record and linked to [3] score-matched recommendations. Introduction into clinical care is supported by [4] the RISQ System implementation package. During the 2 month prior to implementation, front-line staff in the intervention arm will be trained on and will practice the use of the RISQ System .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality. | Mortality over the period beginning at admission to the program and ending at either program discharge or to a maximum of 60 days after study enrolment. Program discharge will be one of: [1] medical/anthropometric criteria or [2] defaulting from the program. Defaulting from the program is defined as children who do not attend the weekly clinic visits for 3 consecutive weeks. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of inpatient mortality | Timing will be defined as [a] within 48 hours of hospital admission and [b] timing of death after admission to hospital | Duration of hospitalization in days up to 60 days | 
| Timing of outpatient mortality | Timing will be defined as [a] within 48 hours of being seen by health-care team [b] timing of death after being seen by outpatient health-care team | Duration of program inclusion in days up to 60 days | 
| Therapeutic intensity | To be measured by location on admission to inpatient care (Intensive Care Unit/Phase1/Phase2) | First 24 hours from admission to hospital | 
| Efficiency of inpatient care | Efficiency measured by length of inpatient stay (whole or part days) | Duration of hospitalization in days up to 60 days | 
| Workload | Frontline staff perception of workload measured through questionnaires using a 5 point scale | Month 1 and month 12 | 
| Knowledge | Frontline staff knowledge of assessment skills measured through questionnaire using a 5 point scale | Month 1 and month 12 | 
| Fidelity of RISQ Implementation | Number of measured vital signs performed on individual patient at health centre visit with corresponding disposition in program, recorded in 10 randomly selected patients/week/health centre | 12 months | 
| Acceptability | Acceptability of the RISQ System by front-line staff evaluated through a questionnaire using a 5 point scale | Month 1 and month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk score, decision support, mortality, illness severity