PediQUEST ResPOND: Piloting an intervention to treat recurrent pain in children with severe neurological impairment

PediQUEST ResPOND：试点干预措施治疗严重神经损伤儿童的复发性疼痛

• 批准号: 10606777
• 负责人: Joanne Wolfe
• 金额: $ 29.39万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-26 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10606777
• 关键词: 1 year old; Academy; Activities of Daily Living; Acute Pain; Address; Adolescent and Young Adult; Advanced Malignant Neoplasm; Advocate; American; Anxiety; Back; Case Series; Central Nervous System Diseases; Child; Child Care; Child Welfare; Childhood; Collection; Complementary therapies; Consultations; Data; Development; Distress; Electronics; Eligibility Determination; Enrollment; Evaluation; Exclusion; Family; Family health status; Feasibility Studies; Feedback; Feeds; Funding; Goals; Health; Impaired cognition; Impairment; Inequity; Intervention; Intervention Studies; Interview; Low income; Malignant Childhood Neoplasm; Manuals; Mediating; Medicine; Mental Depression; Minority; Modeling; Monitor; National Institute of Nursing Research; Neurologic; Outcome; Outcome Measure; Pain; Palliative Care; Parents; Participant; Patients; Pediatrics; Personal Satisfaction; Phase; Pilot Projects; Population; Positioning Attribute; Primary Care; Principal Investigator; Procedures; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Recurrence; Recurrent pain; Reporting; Research; Research Design; Running; Sample Size; Site; Standardization; Stigmatization; Stress; Structure; Surveys; Symptoms; Technology; Testing; Training; World Health Organization; Writing; acceptability and feasibility; chronic pain; coping; design; disability; disadvantaged background; efficacy trial; experience; family burden; health equity promotion; improved; intervention refinement; marginalization; marginalized population; medical specialties; motor impairment; novel; pain behavior; phase III trial; pilot test; psychological distress; recruit; response; screening; sleep quality; social stigma; symptom management; therapy development; treatment as usual

PROJECT SUMMARY In the US, tens of thousands of children, adolescents, and young adults (AYA) are estimated to live with severe neurologic impairment (SNI), a condition that poses an unequal burden on families from minority and low-income backgrounds. Over 60% of these children suffer from uncontrolled pain, which is often persistent, unrecognized, and untreated. The impact extends to their parents who commonly experience unremitting physical and psychological distress. There have been no rigorous intervention studies aimed at treating recurrent pain in children with SNI. This gap may exist because children with SNI are stigmatized and often from historically marginalized backgrounds, and not prioritized in scientific research. To address this inequity and using the ORBIT Model for intervention development, the research team has adapted and refined an intervention previously applied in children with cancer. The PediQUEST Response to Pain Of children with Neurologic Disability (PQ-ResPOND) uses “reciprocal activation” strategies to overcome normalization, the acceptance among parents and clinicians that symptom distress is an unavoidable outcome of serious illness and integration of a specialty pediatric palliative care team (PPC) to respond to child distress. Specifically, PQ-ResPOND will combine (i) parent-mediated activation through weekly collection and feedback to parents and clinicians, via our PQ App, of parent reported child pain (Non-Communicating Children’s Pain Checklist-Revised scale (NCCPC-R)) and other symptoms (PediQUEST-Memorial Symptom Assessment Scale adapted for children with SNI), with (ii) PPC team activation of primary clinicians: through consultation by PPC, and (iii) PPC team activation through training in a standardize recurrent pain approach using the PQ-ResPOND Checklist (adapted by the study’s interprofessional expert panel).The overall hypothesis is that PQ-ResPOND will improve child recurrent pain, and parent distress, burden, and activation. The overall objective of this R21 proposal is to conduct a single site Phase II Pilot Feasibility 2:1 RCT of PQ-ResPOND (intervention, n=30) vs. usual care (control, n=15) in 45 children ≥1 year-old & AYA with SNI and recurrent pain behaviors. A 2-week run-in period will exclude children with mild pain and survey non-responders. Parents of children who meet randomization criteria will answer weekly PQ- ResPOND surveys and monthly outcome surveys over 12 weeks via the PQ App, and a semi-structured exit interview. Specific Aims are to 1. assess the study’s feasibility (>60% enrollment rate and >80% retention), intervention acceptability (>70% parents would recommend the intervention and most parents and clinicians provide positive feedback during qualitative exit interviews), and estimate monthly enrollment rate; and 2. Estimate effect sizes and variability of the proposed trial outcomes: child pain, parent distress and burden (anxiety, depression, stress, burden, overall health, and sleep quality), and parent activation (use of complementary therapies and coping). Results will inform the study design and sample size calculation of a larger Phase III Efficacy trial, development of a manual of procedures and fidelity monitoring strategies. The interprofessional research team has the expertise to expand and test this PPC intervention to ease pain in children with SNI, a novel population that is marginalized, stigmatized, and understudied.

项目摘要 在美国，据估计，成千上万的儿童，青少年和年轻人（AYA）的生活 神经系统障碍（SNI），这种疾病会对少数群体和低收入家庭的家庭造成不平等的燃烧 背景。这些儿童中有60％遭受了不受控制的疼痛，这通常是持久的，无法识别的，并且 未经处理。这种影响扩展到了他们通常经历不舒服身体和心理的父母 困扰。没有严格的干预研究旨在治疗SNI儿童的复发性疼痛。 这种差距可能存在，因为有SNI的儿童受到污名化，并且经常来自历史上的边缘化 背景，在科学研究中没有优先考虑。解决此不平等并使用轨道模型 干预开发，研究小组已经改编并完善了先前对患有儿童的干预措施 癌症。对神经功能障碍儿童疼痛（PQ-RESPOND）对疼痛的童话反应使用“互惠 激活“克服归一化的策略 是严重疾病的不可避免的结果和专业儿科姑息治疗团队（PPC）的融合 到儿童困扰。具体而言，PQ-Respond将通过每周收集和 通过我们的PQ应用程序，父母向父母和临床医生的反馈报告了儿童疼痛（不传播的儿童疼痛 清单重新定义的量表（NCCPC-R）和其他症状（Pediquest-Memorial症状评估量表 适用于SNI的儿童），（ii）PPC团队激活初级临床医生：通过PPC咨询， （iii）PPC团队通过使用PQ-Respond清单进行标准化的经常性疼痛方法来激活PPC团队 （由研究的专业专家小组改编）。总体假设是PQ-Respond将改善儿童 复发性疼痛以及父母的困扰，伯恩和激活。该R21提案的总体目标是进行 单个站点II期飞行员可行性2：1 pq-Respond（干预，n = 30）与通常的护理（对照，n = 15） 45岁的儿童≥1岁，有SNI和经常性疼痛行为。一个2周的磨合期将排除儿童 轻度疼痛和调查无反应者。符合随机化标准的孩子的父母将每周回答PQ- 通过PQ应用程序进行了12周的响应调查和每月结果调查，并进行半结构化退出访谈。 具体目的是1。评估研究的可行性（> 60％的入学率和> 80％的保留率），干预 可接受性（> 70％的父母会推荐干预，大多数父母和临床医生提供积极的 定性退出访谈期间的反馈）和估计每月入学率；和2。估计效应大小和 拟议试验结果的可变性：儿童疼痛，父母的痛苦和烧伤（焦虑，抑郁，压力，烧伤， 总体健康，睡眠质量）以及家长激活（使用补充疗法和应对）。结果将告知 大型III期有效试验的研究设计和样本量计算，开发手册的手册 和保真监控策略。专业专业研究团队具有扩展和测试PPC的专业知识 干预以减轻SNI儿童的疼痛，SNI是一个新型人群，被边缘化，污名化和理解。