Dale Nancy M, Hagre Youssouf Djidita, Shepherd Susan, Tomlinson George, Zlotkin Stanley, Ngaradoum Masra, Bechir Mahmat, Madjissem Marius, Tehoua Charles, Parshuram Christopher
The Hospital for Sick Children, Toronto, Canada.
University of Tampere, Tampere, Finland.
Trials. 2025 Jun 3;26(1):188. doi: 10.1186/s13063-025-08871-1.
The Responses to Illness Severity Quantification (RISQ) System is a scientifically developed clinical decision support tool comprised of four parts: (1) a validated 7-item severity of illness score, (2) age-specific documentation forms, (3) context-relevant score-matched recommendations, and (4) implementation programming. Care recommendations, expertly derived from a panel of clinicians extensively experienced in humanitarian contexts, include frequency of observation, consideration of secondary review, inpatient admission, and transfer into/out of advanced inpatient care areas. The RISQ System is to be used as an adjunct to current care practice to aid clinicians in clinical decision-making. The objective of the CRIMSON study is to estimate the effect of implementation of the RISQ System on mortality and processes of care in a nutritional program.
A cluster randomized trial will compare the RISQ System to usual care. Eligible clusters are community health centers that enroll patients into the Ministry of Health/ALIMA OptiMA acute malnutrition program in the Ngouri district of Chad. Eligible patients are aged 6-59 months with mid-upper arm circumference (MUAC) < 125 mm and/or edema. Participating centers will be allocated in a 1:1 ratio to usual care or the RISQ System. The primary outcome is mortality to the earlier of 60 days after program entry or program discharge. A 14-month baseline period will precede a 14-month intervention period. With a sample of 20,000 patients in 34 centers (assuming an intraclass correlation coefficient of 0.0005, equal-sized clusters, and 1.5% baseline mortality) provides 80% power to detect a 0.5% absolute decrease in mortality using a one-sided alpha of 0.05. Bayesian logistic regression will be used in analyses of the primary outcome.
This cluster randomized evaluation of the RISQ System will estimate effect on program mortality as well as provide detailed information on the implementation of a clinical decision support tool in a low-resource humanitarian setting. Improving the precision of clinical determinations about hospitalization could potentially reduce mortality by 30% within nutrition treatment programs.
ClinicalTrials.gov NCT06123390 . First posted date: 2023-11-08.
疾病严重程度量化反应（RISQ）系统是一种经科学开发的临床决策支持工具，由四个部分组成：（1）经过验证的7项疾病严重程度评分，（2）特定年龄的记录表格，（3）与背景相关的评分匹配建议，以及（4）实施规划。护理建议由在人道主义环境中有丰富经验的临床医生小组精心制定，包括观察频率、二次评估的考虑、住院治疗以及转入/转出高级住院护理区域。RISQ系统将用作当前护理实践的辅助工具，以帮助临床医生进行临床决策。CRIMSON研究的目的是评估RISQ系统的实施对营养项目中死亡率和护理过程的影响。
一项整群随机试验将把RISQ系统与常规护理进行比较。符合条件的群组是在乍得恩古里地区将患者纳入卫生部/阿利马优化急性营养不良项目的社区卫生中心。符合条件的患者年龄在6至59个月之间，上臂中部周长（MUAC）<125毫米和/或有水肿。参与中心将按1:1的比例分配到常规护理组或RISQ系统组。主要结局是项目入组或出院后60天内较早时间的死亡率。在为期14个月的干预期之前将有一个14个月的基线期。在34个中心纳入20000名患者的样本（假设组内相关系数为0.0005，群组规模相等，基线死亡率为1.5%），使用单侧α=0.05，有80%的把握度检测到死亡率绝对降低0.5%。主要结局分析将采用贝叶斯逻辑回归。
对RISQ系统的这项整群随机评估将估计对项目死亡率的影响，并提供在资源匮乏的人道主义环境中实施临床决策支持工具的详细信息。提高关于住院治疗的临床判定的精确度可能会使营养治疗项目中的死亡率降低30%。
ClinicalTrials.gov NCT06123390。首次发布日期：2023年11月8日。
