The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled 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.

Conditions

• Cerebral Palsy Infantile
• Disabilities Multiple
• Pain

Interventions

BEHAVIORAL

PediQUEST ResPOND

PPC teams will have access to feedback reports and the PQ-ResPOND checklist (standardized framework to diagnosis and treatment of recurrent pain behaviors in children with severe neurologic impairment). Integration of the PPC team into care will be achieved through (i) initial consultation (goals: identify treatment goals, and address recurrent pain), and (ii) follow-up: the team will contact or visit the family in response to feedback reports or for treatment monitoring purposes.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Boston Children's Hospital

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Deakin University

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Joanne Wolfe, MD, MPH · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-08

Primary Completion

2025-07-15

Completion

2025-07-31

Countries

• United States
• Australia

Study Locations