PediQUEST ResPOND for Pain in Children with Neurologic Disabilities

(PQ-ResPOND Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Joanne Wolfe, MD, MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Palliative care, Survival <2 months, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this pilot randomized controlled trial is to test the feasibility of running a full scale randomized controlled trial that compares the effect of the PQ-ResPOND intervention versus usual care to improve recurrent pain in children, adolescents, and young adults with severe neurologic impairment. The main questions it aims to answer are: * Is the study feasible and acceptable for participants? * Does PQ-ResPOND have a potential to be effective? Participants will: * answer surveys (their parents will) telling us about the child's pain, symptoms, and use of complementary therapies, and about their own psychological distress and satisfaction with care. * a group will receive the PQ-ResPOND intervention which consists of: * activating parents and providers by using the PediQUEST system, a web platform that administers surveys and generates feedback reports alerting parents and providers about the child's experience, AND * responding to child pain or discomfort by incorporating the Response team (members of the hospital's palliative care team) into the child's care to privde a standardized approach to managing recurrent pain. Researchers will use a comparison (control) group consisting of participants who will answer surveys and receive usual care (no feedback reports or consult with palliative care in this group) to see if a randomized design is feasible.

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 data supports the effectiveness of the treatment PediQUEST ResPOND for pain in children with neurological disabilities?

The research highlights that pain is a common issue in children with neurological impairments, affecting their quality of life. While specific data on PediQUEST ResPOND is not provided, the need for effective pain management in this population is emphasized, suggesting that treatments like PediQUEST ResPOND could be beneficial. ^{1 2 3 4 5}

Is PediQUEST ResPOND safe for children with neurological disabilities?

There is no specific safety data available for PediQUEST ResPOND in the provided research articles. ^{1 2 4 6 7}

How is the PediQUEST ResPOND treatment different from other treatments for pain in children with neurological disabilities?

PediQUEST ResPOND is unique because it focuses on a comprehensive approach to managing pain in children with neurological disabilities, where traditional treatments often lack specific guidelines. It likely involves a multidisciplinary approach, considering the complex needs of these children, which is not commonly addressed in standard pain management practices. ^{2 4 7 8 9}

Research Team

Joanne Wolfe, MD, MPH

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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 read, write, and speak English or Spanish

Parents are unable to understand and complete surveys

Trial Timeline

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

Treatment Details

Interventions

• PediQUEST ResPOND (Behavioral Intervention)

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.

Participant Groups

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+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Dr. Kevin B. Churchwell

Boston Children's Hospital

Chief Executive Officer since 2021

MD from Vanderbilt Medical School

Dr. Sarah Pitts

Boston Children's Hospital

Chief Medical Officer since 2019

MD from Harvard Medical School

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Deakin University

Collaborator

Trials

38

Recruited

21,900+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Biobehavioral responses to acute pain in adolescents with a significant neurologic impairment. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[Pain in children with neurological impairment: A review from the French Pediatric Neurology Society]. [2018]

3. Netherlands 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of children with severe neurological impairment admitted to hospital with pain and irritability. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Measuring physical function in children with airway support: a pilot study using computer adaptive testing. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety Issues of Pharmacological Acute Pain Treatment in Children. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Pain, anxiety, and cooperativeness in children with cerebral palsy after rhizotomy: changes throughout rehabilitation. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Pain in cognitively impaired children: a focus for general pediatricians. [2021]

9. United States 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. [2015]