Evaluating RISQ System Implementation in Acutely Malnourished Children in Chad (CRIMSON)
NCT ID: NCT06123390
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20000 participants
INTERVENTIONAL
2023-09-11
2024-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Community health centres will be the randomized clusters.
SUPPORTIVE_CARE
SINGLE
Study Groups
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Usual Care
The 17 health centres randomized to "Usual Care" will provide care as per OptiMA program.
No interventions assigned to this group
Intervention Arm
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.
The Responses to Illness Severity Quantification (RISQ) System
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 .
Interventions
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The Responses to Illness Severity Quantification (RISQ) System
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 .
Eligibility Criteria
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Inclusion Criteria
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
1. Children allergic to milk, peanuts and/or ready-to-use therapeutic food (RUTF)
2. Children not residing in one of the study areas.
6 Months
59 Months
ALL
No
Sponsors
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Alliance for International Medical Action
OTHER
University of N'Djaména, Chad
UNKNOWN
The Hospital for Sick Children
OTHER
Responsible Party
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Christopher Parshuram
Staff Physician, Paediatric Intensive Care Unit, Department of Critical Care Medicine
Principal Investigators
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Christopher Parshuram, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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Ngouri
Ngouri, , Chad
Countries
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Central Contacts
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Facility Contacts
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Youssouf Djitida Hagre, MD
Role: primary
References
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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.
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.
Dale NM, Hagre YD, Shepherd S, Tomlinson G, Zlotkin S, Ngaradoum M, Bechir M, Madjissem M, Tehoua C, Parshuram C. 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. Trials. 2025 Jun 3;26(1):188. doi: 10.1186/s13063-025-08871-1.
Related Links
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World Health Organization. Guideline: Updates on the Management of Severe Acute Malnutrition in Infants and Children \[Internet\]. 2013.
World Health Organization. Pocket Book of Hospital Care for Children: Guidelines for the Management of Common Childhood Illnesses, 2013.
World Health Organization. Handbook IMCI: Integrated Management of Childhood Illness \[Internet\]. 2005.
Exploratory meeting to review new evidence for Integrated Management of Childhood Illness (IMCI) danger signs
Other Identifiers
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1000080735
Identifier Type: -
Identifier Source: org_study_id