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Behavioral Intervention

PediQUEST ResPOND for Pain in Children with Neurologic Disabilities (PQ-ResPOND Trial)

N/A

Recruiting

Led By Joanne Wolfe, MD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child participants must be ≥ 1 year old

Must not have

Parents do not have legal guardianship

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a new intervention called PQ-ResPOND can help improve recurrent pain in children, adolescents, and young adults with severe neurologic impairment. Participants will either receive the intervention

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on survey responses and standardizing care approaches rather than medication or invasive procedures, traditional side effects are not the primary concern; however, any potential discomfort from increased attention to pain management will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is at least 1 year old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My parents are not my legal guardians.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence with answering surveys

Clinician's acceptability of intervention (qualitative)

Demographics of dropouts

+14 more

Secondary study objectives

Child pain

Child symptom burden

Parent Anxiety

+11 more

Other study objectives

Progression criteria: Feasibility of intervention delivery

Progression criteria: Participant's acceptability of intervention

Progression criteria: Recruitment rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PQ-ResPOND (Intervention)Experimental Treatment1 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 Control1 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.

0 / 2Eligibility criteria met