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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Acute Malnutrition
• Intervention / Treatment: Other: The Responses to Illness Severity Quantification (RISQ) System

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.

• Study Type: Interventional
• Enrollment (Estimated): 20000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy M Dale, PhD; Phone Number: 206486 416-813-6486; Email: nancy-m.dale@sickkids.ca

Study Locations

• Chad
  • Ngouri, Chad
    • Recruiting
    • Ngouri
    • Contact: Youssouf Djitida Hagre, MD; Email: djiditi20@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; The 17 health centres randomized to "Usual Care" will provide care as per OptiMA program.
Experimental: 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.	Other: 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 .

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lived experience of RISQ System implementation	Lived experiences measured by open ended questions about strengths/weaknesses of RISQ System implementation added to frontline staff perception questionnaire at end of intervention period	one time at end of 12 month implementation period
comparison of automated versus manual measurements of vital signs (Respiratory rate in breaths/min)	Comparison determined by agreement between the two different methods for respiratory rate measurement	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)	Comparison determined by agreement between the two different methods for temperature measurement	During run-in phase prior to implementation of intervention, on average 2 months
Comparison of RISQ scores among children with different clinical conditions in inpatient care	Differences in RISQ scores among children with different clinical diagnoses a) on admission to inpatient care; b) throughout inpatient care; and c) at exit from inpatient care	Duration of hospitalization in days up to 60 days

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Alliance for International Medical Action; University of N'Djaména, Chad
• Investigators: Principal Investigator: Christopher Parshuram, MD, PhD, The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: mortality; risk score; illness severity; decision support
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: 1000080735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: On reasonable request - after publication of the study and with permission of parties attached to the study, and after Research Ethics Board review and approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No