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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cerebral Palsy Infantile
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Birmingham, Alabama, United States, 35294

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Parent-child dyads will be included based on the following criteria:
  • * ≥ 1 year old,
  • * receiving routine (ongoing) care at Boston Children's Hospital, AND
  • * followed by the Neurology, Cerebral Palsy or Complex Care services.
  • * has severe neurological impairment, defined as:
  • * a Central Nervous System disorder resulting in motor and cognitive impairment and an inability to communicate either verbally or through sign language, AND
  • * has complete caregiver dependency for activities of daily living AND
  • * date of diagnosis of SNI is ≥ 4 months prior to the date of screening
  • * Parent-child dyads will be excluded if any of the following apply:
  • * the child,
  • * is already followed by the palliative care team, OR
  • * is not expected to survive at least 2 months after enrollment; OR
  • * does not have "moderate to severe recurrent pain", as measured through the baseline Child Pain Survey (PPP). Specifically, we will exclude participants whose:
  • * "Good days" AND "Difficult days" PPP scores are \<14, AND
  • * "Most troublesome pain" PPP score is \<30, AND
  • * Number of "difficult days" are \<8 in past month, AND
  • * Number of days with "most troublesome pain" are \<4 in past month; OR • both parents,
  • * do not have legal guardianship, OR
  • * are unable to read, write, and speak English OR Spanish
  • * are unable to understand and complete surveys.

Ages Eligible for Study

1 Year to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Joanne Wolfe, MD, MPH, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2025-07-15