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.

项目总结 在美国，据估计，数以万计的儿童、青少年和年轻人(Aya)患有严重的 神经功能障碍(SNI)，这是一种对少数族裔和低收入家庭造成不平等负担的疾病 背景。其中超过60%的儿童遭受无法控制的疼痛，这种疼痛通常是持续的、未被认识到的和 未经治疗。这种影响延伸到他们的父母，他们通常经历着坚持不懈的身体和心理 苦恼。目前还没有针对SNI儿童复发性疼痛的严格干预研究。 这种差距的存在可能是因为患有SNI的儿童受到耻辱，而且往往来自历史上被边缘化的儿童 背景，而且在科学研究中没有被优先考虑。为了解决这种不平等，并使用轨道模型 在干预发展方面，研究小组调整和完善了以前应用于儿童的干预措施 癌症。神经功能障碍儿童对疼痛的反应(PQ-Response)使用“互惠” “激活”策略，以克服正常化，父母和临床医生接受症状困扰 是严重疾病不可避免的结果，并整合了一个专门的儿科姑息治疗小组(PPC)来应对 孩子们的痛苦。具体地说，PQ-Response将结合(I)家长通过每周收集和 通过我们的PQ App向家长和临床医生反馈家长报告的儿童疼痛(非传播性儿童疼痛 检查表-修订量表(NCCPC-R)和其他症状(PediQUEST-纪念性症状评估量表 适用于SNI儿童)，(Ii)初级临床医生的PPC团队激活：通过PPC咨询，以及 (3)通过使用PQ-Response Checklist进行标准化复发性疼痛方法培训来激活PPC团队 (由研究的跨专业专家小组改编)。总体假设是PQ-Response将改善儿童 反复疼痛，以及父母的痛苦、负担和活跃。此R21提案的总体目标是进行 单点第二阶段试点可行性2：1 PQ-Response(干预，n=30)RCT与常规护理(n=15，n=15) 45名1岁的儿童≥&AYA伴有SNI和反复疼痛行为。两周的磨合期将不包括患有以下疾病的儿童 轻微疼痛，并询问无反应者。符合随机标准的儿童的父母将回答每周的PQ- 通过PQ App进行为期12周的回复调查和月度结果调查，以及半结构化的离职访谈。 具体目标是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%的家长会建议进行干预，大多数家长和临床医生提供肯定的意见 定性离职面试期间的反馈)，并估计每月的入学率；以及2.估计效果大小和 拟议试验结果的变异性：儿童疼痛、父母痛苦和负担(焦虑、抑郁、压力、负担、 总体健康和睡眠质量)，以及父母的激活(使用补充疗法和应对)。结果将通知 大型III期疗效试验的研究设计和样本量计算，制定程序手册 以及保真度监控策略。跨专业的研究团队拥有扩展和测试这一PPC的专业知识 干预以减轻SNI儿童的痛苦，SNI是一个被边缘化、被污名化和研究不足的新人群。