Adaptive Intervention to Prevent Respiratory Illness in Cerebral Palsy: Protocol for a Feasibility Pilot Randomized Controlled Trial.
Adaptive Intervention to Prevent Respiratory Illness in Cerebral Palsy: Protocol for a Feasibility Pilot Randomized Controlled Trial.
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DOI：
10.2196/49705
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发表时间：
2024-01-08
影响因子：
1.7
通讯作者：
Coller, Ryan
中科院分区：
文献类型：
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作者：
Fleischman, Alyssa;Lerner, Carlos;Kloster, Heidi;Chung, Paul;Klitzner, Thomas;Cushing, Christopher;Gerber, Danielle;Katz, Barbara;Warner, Gemma;Singh-Verdeflor, Kristina Devi;Delgado-Martinez, Roxana;Porras-Javier, Lorena;Ia, Siem;Wagner, Teresa;Ehlenbach, Mary;Coller, Ryan
这项研究将对一种创新的及时适应性干预进行试点测试，以减少重度脑瘫（CP）儿童的严重呼吸道疾病。我们的干预计划，呼吸急性发作-行动和护理过渡计划（RE-PACT），在住院风险升高时提供及时的定制行动计划和快速的临床响应。本研究的目的是建立RE-PACT的可行性，可接受性和保真度高达90名儿童严重CP。另一个目的是初步估计RE-PACT的效应量。该研究将招募多达90名0至17岁重度CP儿童的护理人员，这些儿童由呼吸专家护理或正在接受日常呼吸治疗。参与者将从威斯康星大学麦迪逊分校（UW）和加州大学洛杉矶分校（UCLA）的儿科综合护理项目中招募。研究参与者将被随机分配接受UW或UCLA的复杂护理临床项目或研究干预RE-PACT的常规护理。干预措施包括行动计划，快速临床反应，以预防和管理呼吸系统疾病，以及每周短信监测照顾者对他们的孩子的信心，以避免住院。RE-PACT将通过3个连续较大的6个月试验波运行，允许根据预先规定的可行性、可接受性和保真度指标的成功定义进行持续的方案优化。可行性措施包括招募和干预时间。可接受性指标包括招募率和完成率以及干预满意度。忠实度的衡量标准包括观察到的干预和数据收集活动的比率与预期比率。主要临床结局为重度呼吸系统疾病，定义为需要住院治疗的呼吸系统诊断。次要临床结局包括住院天数和急诊就诊、全身类固醇疗程、全身抗生素疗程和严重呼吸道疾病死亡。第一波招募于2022年4月27日开始。到目前为止，我们已经招募了90名参与者中的30名（33%）。最后一波招募将于2023年10月31日结束，最终参与者将于2024年4月30日完成研究。我们将在2024年4月30日之前开始分析完整的回复，预计将在2024年底公布结果。这种试点干预，采用适应性及时策略，代表了一种新的方法，以减少严重CP儿童的重大呼吸系统疾病的发病率。该方案可能有助于其他研究人员和医疗保健提供者照顾急性重症疾病加重的高风险患者。ClinicalTrials.gov NCT 05292365; https://clinicaltrials.gov/study/NCT05292365 DERR 1 -10.2196/49705
This study will pilot-test an innovative just-in-time adaptive intervention to reduce severe respiratory illness among children with severe cerebral palsy (CP). Our intervention program, Respiratory Exacerbation–Plans for Action and Care Transitions (RE-PACT), delivers timely customized action planning and rapid clinical response when hospitalization risk is elevated. This study aims to establish RE-PACT’s feasibility, acceptability, and fidelity in up to 90 children with severe CP. An additional aim is to preliminarily estimate RE-PACT’s effect size. The study will recruit up to 90 caregivers of children with severe CP aged 0 to 17 years who are cared for by a respiratory specialist or are receiving daily respiratory treatments. Participants will be recruited from pediatric complex care programs at the University of Wisconsin–Madison (UW) and the University of California, Los Angeles (UCLA). Study participants will be randomly assigned to receive usual care through the complex care clinical program at UW or UCLA or the study intervention, RE-PACT. The intervention involves action planning, rapid clinical response to prevent and manage respiratory illness, and weekly SMS text messaging surveillance of caregiver confidence for their child to avoid hospitalization. RE-PACT will be run through 3 successively larger 6-month trial waves, allowing ongoing protocol refinement according to prespecified definitions of success for measures of feasibility, acceptability, and fidelity. The feasibility measures include recruitment and intervention time. The acceptability measures include recruitment and completion rates as well as intervention satisfaction. The fidelity measures include observed versus expected rates of intervention and data collection activities. The primary clinical outcome is a severe respiratory illness, defined as a respiratory diagnosis requiring hospitalization. The secondary clinical outcomes include hospital days and emergency department visits, systemic steroid courses, systemic antibiotic courses, and death from severe respiratory illness. The recruitment of the first wave began on April 27, 2022. To date, we have enrolled 30 (33%) out of 90 participants, as projected. The final wave of recruitment will end by October 31, 2023, and the final participant will complete the study by April 30, 2024. We will start analyzing the complete responses by April 30, 2024, and the publication of results is expected at the end of 2024. This pilot intervention, using adaptive just-in-time strategies, represents a novel approach to reducing the incidence of significant respiratory illness for children with severe CP. This protocol may be helpful to other researchers and health care providers caring for patients at high risk for acute severe illness exacerbations. ClinicalTrials.gov NCT05292365; https://clinicaltrials.gov/study/NCT05292365 DERR1-10.2196/49705
DOI：
10.1016/j.jpeds.2020.11.049
发表时间：
2021-03
期刊：
The Journal of pediatrics
影响因子：
--
作者：
Coller RJ;Lerner CF;Berry JG;Klitzner TS;Allshouse C;Warner G;Nacht CL;Thompson LR;Eickhoff J;Ehlenbach ML;Bonilla AJ;Venegas M;Garrity BM;Casto E;Bowe T;Chung PJ
通讯作者：
Chung PJ