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

Completed · Not applicable

Conditions studied: Cerebral Palsy Infantile, Disabilities Multiple, Pain

In brief

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.

Key facts

Study ID

NCT06075797

Run by

Massachusetts General Hospital

People needed

54

Starts

2024-05-08

Expected to finish

2025-07-31

Last updated by the study team

2026-01-21

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parent-child dyads will be included based on the following criteria:
• Child participants will be selected from the base population of patients who are:
• ≥ 1 year old,
• receiving routine (ongoing) care at Boston Children's Hospital, AND
• followed by the Neurology, Cerebral Palsy or Complex Care services.
• All patients from the base population will be screened to include any patient who:
• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Deakin University — Burwood, Victoria, Australia

Full record on ClinicalTrials.gov

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