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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要在美国，估计有数以万计的儿童、青少年和年轻人 (AYA) 患有严重的疾病神经功能障碍 (SNI)，这种疾病给少数族裔和低收入家庭带来不平等的负担超过 60% 的儿童患有无法控制的疼痛，这种疼痛通常是持续性的、未被识别的，并且难以被察觉。这种影响延伸到了他们的父母，他们通常经历着持续不断的身心困扰。目前尚无旨在治疗 SNI 儿童复发性疼痛的严格干预研究。这种差距可能存在，因为患有 SNI 的儿童受到污名化，并且往往来自历史上的边缘化群体为了解决这种不平等问题，并使用 ORBIT 模型进行研究。干预措施的发展，研究小组调整并完善了之前应用于患有以下疾病的儿童的干预措施： PediQUEST 对神经障碍儿童疼痛的反应 (PQ-ResPOND) 使用“互惠” 激活”策略来克服正常化、父母的接受度和症状困扰是严重疾病不可避免的结果，需要专业儿科姑息治疗团队 (PPC) 的整合来应对具体来说，PQ-ResPOND 将结合 (i) 通过每周收集和家长介导的激活。通过我们的 PQ 应用程序向家长和指挥官反馈家长报告的儿童疼痛（非沟通性儿童疼痛检查表修订量表（NCCPC-R））和其他症状（PediQUEST-纪念症状评估量表适合患有 SNI 的儿童），(ii) 主要东南部的 PPC 团队激活：通过 PPC 协商，以及 (iii) 通过使用 PQ-ResPOND 检查表进行标准化复发性疼痛方法培训来激活 PPC 团队（由该研究的跨专业专家小组改编）。总体假设是 PQ-ResPOND 将改善儿童复发性疼痛以及家长的痛苦、负担和激活该 R21 提案的总体目标是进行。 PQ-ResPOND（干预，n=30）与常规护理（对照，n=15）的单点 II 期试点可行性 2:1 RCT 45 名 ≥1 岁且患有 SNI 和反复疼痛行为的 AYA 儿童 2 周的磨合期将排除患有以下疾病的儿童。轻度疼痛和调查无反应的儿童的家长将每周回答 PQ-。通过 PQ 应用程序进行超过 12 周的 ResPOND 调查和每月结果调查，以及半结构化退出访谈。具体目标是 1. 评估研究的可行性（>60% 入组率和 >80% 保留率）、干预可接受性（>70% 的家长会建议干预，大多数家长和教区居民都提供积极的态度）定性退出访谈期间的反馈），并估计每月入学率；以及 2. 估计效应大小和拟议试验结果的可变性：儿童疼痛、家长痛苦和负担（焦虑、抑郁、压力、负担、整体健康状况和睡眠质量），以及家长激活（使用补充疗法和应对措施）。更大的 III 期疗效试验的研究设计和样本量计算，制定程序手册跨专业研究团队拥有扩展和测试此 PPC 的专业知识。缓解 SNI 儿童疼痛的干预措施，这是一个被边缘化、污名化和研究不足的新人群。