The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial — PQ-ResPOND  

Pain Clinical Trial

Official title: Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Background: In the US, tens of thousands of children, adolescents, and young adults (AYA) are estimated to live with severe neurologic impairment (SNI). Over 60% of these children endure uncontrolled and often persistent pain, which frequently goes unrecognized and untreated. The impact extends to their parents who commonly experience unremitting physical and psychological distress. There has been a lack of rigorous studies that focus on interventions to alleviate recurrent pain in children with SNI. This gap might be attributed to the stigmatization of these children, who are often from historically marginalized backgrounds, resulting in a low prioritization in research endeavors. To address this inequity and using the ORBIT Model for intervention development, the investigators have adapted and are refining an intervention previously applied in children with cancer. The PediQUEST Response to Pain Of children with Neurologic Disability (PQ-ResPOND) will respond to child distress by using "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). The overall objective of the study is to evaluate the feasibility of running a full-scale RCT that compares the effect of the PediQUEST ResPOND intervention vs. usual care in children and AYA with SNI.

Specific Aims are to 1. assess study's feasibility and acceptability by evaluating recruitment (rates and suitability of screening/tracking), adherence to the intervention (by study participants and interventionists), and retention (dropout rates, reasons, and demographics); and, 2. explore potential for intervention's efficacy by estimating effect sizes and variability of the outcomes proposed for the full-scale RCT (child recurrent pain and symptom burden, and parent outcomes) and assessing intervention's acceptability through semi-structured interviews.

Methods: Researchers will conduct a single site Phase II Pilot 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 moderate to severe recurrent pain behaviors. After randomization, participants will answer weekly PQ-ResPOND surveys and monthly outcome surveys over 12 weeks via the PQ App, and a semi-structured exit interview. Intervention: participants assigned to this arm will receive the PQ-ResPOND intervention which combines (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-mediated activation of primary clinicians and parents: through PPC consultation, and (iii) PPC team activation through training in a standardized approach to recurrent pain using the PQ-ResPOND Checklist (adapted by the study's interprofessional expert panel). Usual care: participants in this arm will continue receiving care as usual.

Outcomes: Investigators will use quantitative and qualitative outcomes to study feasibility and acceptability including recruitment and retention rates, intermittent attrition, adherence to intervention delivery by clinicians, and participant and clinician's acceptability of the intervention. To preliminarily estimate effect sizes and variability, the corresponding scores for child's pain and symptom burden, and parent distress and activation measures will be estimated.

Analysis: For feasibility and acceptability quantitative outcomes investigators will use descriptive statistics. Demographics and reasons for attrition will be reported to explore potential for selection bias. A focused thematic analysis will be used to analyze qualitative variables. To estimate effect sizes and variability of trial outcomes, mixed linear regression models will be estimated. A predefined set of progression criteria are in place.

Discussion: Results will inform whether a full-scale Phase III RCT is warranted, and will help with study design and sample size calculation, development of a manual of procedures and fidelity monitoring strategies. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Infantile
• Disabilities Multiple
• Pain

• NCT number: NCT06075797
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Madeline E Avery, MPH
• Phone: 617 643 8846
• Email: meavery@mgh.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Completion date: July 15, 2025