PediQUEST ResPOND for Pain in Children with Neurologic Disabilities

(PQ-ResPOND Trial)

Recruiting at 3 trial locations

Overseen By Veronica Dussel, MD, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Palliative care, Survival <2 months, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to managing pain in children with serious neurological disabilities. It tests whether a web-based system called PediQUEST ResPOND, which alerts parents and doctors about a child's pain, can improve care when combined with specialized palliative care support. The study includes children with neurological disorders affecting movement and communication who rely entirely on caregivers for daily activities. Participants will either receive this new intervention or continue with their usual care to determine if the new method is both feasible and helpful. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative care strategies that could enhance the quality of life for children with neurological disabilities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a web platform and palliative care team to manage pain, so it's best to discuss your medications with the trial team.

What prior data suggests that the PQ-ResPOND intervention is safe for children with neurologic disabilities?

Research shows that the PediQUEST ResPOND program helps manage and reduce pain in children with severe neurological issues. It uses a web platform to gather and share information about a child's symptoms, guiding a team of specialized palliative care experts.

For safety, the PediQUEST ResPOND program focuses on improving communication and managing symptoms, without introducing new medications or procedures. Current research has not found any harmful effects from this approach. Instead, it provides families and healthcare providers with better tools to understand and address a child's pain.

This trial is in the "Not Applicable" phase, meaning it primarily checks if the study design works well and is acceptable to participants. While direct safety data might be limited, the program's nature—using surveys and consultations with care teams—suggests it is likely to be well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PediQUEST ResPOND because it takes a unique approach to managing pain in children with neurologic disabilities. Unlike standard care, which often involves diverse teams of specialists and typical palliative care consultations, PediQUEST ResPOND combines weekly surveys with personalized feedback and direct involvement from a pediatric palliative care team. This method not only focuses on recurrent pain but also actively engages families in the care process, potentially leading to more tailored and effective pain management strategies.

What evidence suggests that the PQ-ResPOND intervention could be effective for managing recurrent pain in children with neurologic disabilities?

Research has shown that the PediQUEST ResPOND system improves pain management by involving both families and healthcare providers. In this trial, participants in the intervention arm will use the PediQUEST ResPOND system, which generates reports about a child's pain and symptoms to help healthcare teams respond more effectively. This arm also includes engagement with a special palliative care team to ensure thorough management of ongoing pain. Studies have found that when doctors receive feedback from patients about their symptoms, it leads to better care for children with serious illnesses. This method has proven effective in similar situations, suggesting it could also benefit children with neurological disabilities. ^{1 2 5 6 7}

Who Is on the Research Team?

Joanne Wolfe, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for children, adolescents, and young adults with severe neurologic impairment due to conditions like cerebral palsy. They must be at least a year old, diagnosed over 4 months ago, unable to communicate traditionally, fully dependent on caregivers for daily activities, and receiving care at Boston Children's Hospital.

Inclusion Criteria

I have a severe brain disorder causing major physical and thinking problems, needing full-time care, diagnosed over 4 months ago.

My child is at least 1 year old.

Child participants must be receiving routine care at Boston Children's Hospital

Exclusion Criteria

Child is already followed by the palliative care team

Parents are unable to understand and complete surveys

Child is not expected to survive at least 2 months after enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PQ-ResPOND intervention or usual care, with weekly surveys and feedback for 12 weeks

12 weeks

Weekly surveys (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Exit Interview

Participants complete a semi-structured exit interview to assess feasibility and acceptability

1 visit

What Are the Treatments Tested in This Trial?

Interventions

• PediQUEST ResPOND

Trial Overview The study tests the PQ-ResPOND intervention against usual care in managing recurrent pain. PQ-ResPOND activates parents/providers using PediQUEST web surveys and involves a Response team from palliative care for standardized pain management. The control group only answers surveys without additional interventions.

How Is the Trial Designed?

Group I: PQ-ResPOND (Intervention) Experimental Treatment 1 Intervention

Participants in the intervention arm will (i) answer weekly PQ-ResPOND Surveys over 12 weeks, (ii) receive feedback reports (generated by the PediQUEST system to summarize parents answers), and (iii) engage with the pediatric palliative care (PPC) team. The interprofessional PPC team will focus on child's recurrent pain and related symptoms using a standardized approach and work on family activation strategies.

Group II: Usual care (Control) Active Control 1 Intervention

Participants randomized to the control arm will be assigned weekly PQ-ResPOND Surveys up to week 12. Participants in this arm will not have access to the full PediQUEST system, i.e. no reports will be generated. They will not meet the PPC team but can receive regular palliative care consultations following the site's usual referral procedures. Children in the usual care arm will receive standard care, which at Boston Children's Hospital usually involves several primary clinicians (primarily neurologists or Complex Care Service attending physicians) and access to psychosocial clinician care throughout the illness course. PPC referrals are typically made at the discretion of the primary clinician, often for decision making reasons and/or closer to end-of-life. If a child presents persistent distress, they will be cared through the usual mechanisms. The rationale for collecting weekly surveys is to minimize reporting bias and may increase adherence and retention.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Deakin University

Collaborator

Trials

38

Recruited

21,900+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

In a study of 32 children with spastic cerebral palsy undergoing rehabilitation after selective posterior rhizotomy, it was found that pain and anxiety levels decreased over time, while physical functioning and cooperativeness improved.

The study revealed that cognitive impairment, parental involvement, and children's pain behaviors significantly influenced cooperativeness, explaining a large portion of the variance in this behavior, highlighting the importance of these factors in pain assessment and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain, anxiety, and cooperativeness in children with cerebral palsy after rhizotomy: changes throughout rehabilitation. Miller, AC., Johann-Murphy, M., Cate, IM.[2019]

In a study of 107 children with hemiplegic cerebral palsy, 48% reported experiencing pain, primarily affecting the involved side and lower limbs, with 35% experiencing moderate to severe pain.

Children with pain had significantly lower quality of life and self-perception scores compared to those without pain, indicating that effective pain management should be a priority in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain characteristics and their association with quality of life and self-concept in children with hemiplegic cerebral palsy identified from a population register. Russo, RN., Miller, MD., Haan, E., et al.[2015]

Pain is prevalent in 50-75% of children with neurological impairments, significantly affecting their quality of life and that of their families, yet the medical literature on this topic is very limited, comprising only 0.15% of all pain-related publications.

Effective pain management in these children is challenging due to the lack of specific guidelines; however, a multidisciplinary approach involving various healthcare professionals is recommended, and behavioral rating scales tailored to this population can enhance pain assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain in children with neurological impairment: A review from the French Pediatric Neurology Society]. Avez-Couturier, J., Joriot, S., Peudenier, S., et al.[2018]

The 'Questionnaire on Pain caused by Spasticity (QPS)' was developed through interviews with 21 children with cerebral palsy and their caregivers, ensuring that the tool reflects the real experiences of patients regarding spasticity-related pain.

The QPS includes both child/adolescent and parent modules, making it adaptable for various communication skills and providing a comprehensive assessment of pain, which was found to be relevant and easy to use by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative development of the 'Questionnaire on Pain caused by Spasticity (QPS),' a pediatric patient-reported outcome for spasticity-related pain in cerebral palsy. Geister, TL., Quintanar-Solares, M., Martin, M., et al.[2021]

Children require careful consideration when managing acute pain due to differences in how their bodies process medications compared to adults, making them more vulnerable to safety issues.

The review emphasizes the importance of individualized treatment and proper dosing of analgesics like acetaminophen, NSAIDs, and opioids to ensure effective pain relief while minimizing the risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Issues of Pharmacological Acute Pain Treatment in Children. Rodieux, F., Piguet, V., Desmeules, J., et al.[2020]

Pain is highly prevalent among children with cognitive impairment and cerebral palsy, significantly affecting their quality of life, but it can often be treated and prevented.

Validated pain assessment tools are essential for diagnosing pain in non-verbal patients, yet many pediatricians may not be fully aware of the importance of addressing pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain in cognitively impaired children: a focus for general pediatricians. Massaro, M., Pastore, S., Ventura, A., et al.[2021]

The PEDI-MCAT effectively measured changes in self-care and mobility for children in inpatient pulmonary rehabilitation, showing significant improvements in most cases, except for mobility in the prematurity group.

This assessment tool is efficient, taking an average of just 1.57 minutes to complete and requiring only a small number of items to generate scores, which can help reduce the workload for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring physical function in children with airway support: a pilot study using computer adaptive testing. Dumas, HM., Rosen, EL., Haley, SM., et al.[2019]

In a study involving 8 adolescents with significant neurologic impairment, heart rate and facial expressions were monitored during mock and real vaccine injections, revealing that pain responses were generally lower than expected during the actual injection.

Despite higher visual analog scale (VAS) scores during the injection phase, other measures did not show significant differences, suggesting a complex and potentially reduced pain response in this population that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biobehavioral responses to acute pain in adolescents with a significant neurologic impairment. Oberlander, TF., Gilbert, CA., Chambers, CT., et al.[2019]

In a study of six children with severe neurological impairment (SNI) admitted to a pediatric hospital, only three had their pain and irritability resolved, highlighting challenges in identifying pain sources in this population.

The analysis revealed significant gaps in the clinical approach to assessing pain, suggesting that implementing the Pain and Irritability of Unknown Origin (PIUO) pathway could improve the identification and treatment of pain in children with SNI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of children with severe neurological impairment admitted to hospital with pain and irritability. Fishman, I., Siden, H., Vadeboncoeur, C.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06075797

The PediQUEST Response to Pain Of Children With ... The PediQUEST Response to Pain Of children with Neurologic Disability (PQ-ResPOND) will respond to child distress by using "reciprocal activation" strategies ...

2. ctv.veeva.com ctv.veeva.com/study/the-pediquest-response-to-pain-of-children-with-neurologic-disability-pilot-randomized-controlled-tr

The PediQUEST Response to Pain Of Children With ... The PediQUEST Response to Pain Of children with Neurologic Disability (PQ-ResPOND) will respond to child distress by using "reciprocal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3970170/

Results From the PediQUEST Randomized Controlled Trial This study aimed to determine whether feeding back patient-reported outcomes (PROs) to providers and families of children with advanced cancer improves symptom ...

4. withpower.com withpower.com/trial/pediquest-respond-for-pain-in-children-with-neurologic-disabilities-bfc78

PediQUEST ResPOND for Pain in Children with ... PediQUEST ResPOND is unique because it focuses on a comprehensive approach to managing pain in children with neurological disabilities, where traditional ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0277212

The PediQUEST Response Study Protocol | PLOS One PQ Response is a multicomponent intervention designed to activate the symptom management process through two core components: PQ web system ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03408314

The PediQUEST Response Intervention Study PediQUEST Response consists of regular feedback of electronic patient reported outcomes (child symptoms and quality of life) to providers and families coupled ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36346783/

The PediQUEST Response Study Protocol - PubMed - NIH Multisite, randomized (1:1), controlled, un-blinded, effectiveness trial comparing PediQUEST Response (intervention) vs usual cancer care (control).