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

NCT06123390 | Unknown DMC

• 1 other identifier: 1000080735
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Malnutrition

Keywords

decision support; mortality; illness severity; risk score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Timing of inpatient mortality

  Duration of hospitalization in days up to 60 days

• Timing of outpatient mortality

  Duration of program inclusion in days up to 60 days

• Therapeutic intensity

  First 24 hours from admission to hospital

• Efficiency of inpatient care

  Duration of hospitalization in days up to 60 days

• Workload

  Month 1 and month 12

Other Outcomes (4)

• Lived experience of RISQ System implementation

  one time at end of 12 month implementation period

• comparison of automated versus manual measurements of vital signs (Respiratory rate in breaths/min)

  During run-in phase prior to implementation of intervention, on average 2 months

• comparison of automated versus manual measurements of vital signs (Temperature in degrees Celsius)

  During run-in phase prior to implementation of intervention, on average 2 months

Study Arms (2)

Usual Care

NO INTERVENTION

The 17 health centres randomized to "Usual Care" will provide care as per OptiMA program.

Intervention Arm

EXPERIMENTAL

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

Interventions

The Responses to Illness Severity Quantification (RISQ) System OTHER

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 .

Intervention Arm

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Alliance for International Medical Action: collaborator
• University of N'Djaména, Chad: collaborator

Study Sites (1)

Ngouri

Ngouri, Chad

RECRUITING

Related Publications (3)

• 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.

  PMID: 35582782 BACKGROUND

• 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.

  PMID: 37419241 BACKGROUND

• 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.

  PMID: 40462129 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Severe Acute Malnutrition

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Christopher Parshuram, MD, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy M Dale, PhD

CONTACT

416-813-6486; nancy-m.dale@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants and care providers will know which arm of the study they are part of, as the randomization occurs at the facility level. Only the statistician will be blinded to the arms at the time of analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Paediatric Intensive Care Unit, Department of Critical Care Medicine

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: September 11, 2023
• Primary Completion: August 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)