CompletedNot Applicable

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

United States, Australia54 participantsStarted 2024-05-08

Plain-language 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.

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment rate

Timeframe: 16 months

Recruitment/month

Timeframe: 16 months

Randomization rate

Timeframe: 16 months

Suitability of screening/tracking

Timeframe: 16 months

Sample diversity

Timeframe: 16 months

Refusal reasons

Timeframe: 16 months

Dropout rate

Timeframe: 16 months

Demographics of dropouts

Timeframe: 16 months

Trial details

NCT IDNCT06075797

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-15

View on ClinicalTrials.gov More Cerebral Palsy Infantile trials

Plain-language summary

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Recruitment rate

Timeframe: 16 months

Recruitment/month

Timeframe: 16 months

Randomization rate

Timeframe: 16 months

Suitability of screening/tracking

Timeframe: 16 months

Sample diversity

Timeframe: 16 months

Refusal reasons

Timeframe: 16 months

Dropout rate

Timeframe: 16 months

Demographics of dropouts

Timeframe: 16 months