Improving pain management in children with severe neurologic impairment
Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)
This study is testing a new online program to help parents and doctors manage pain better in children and young adults with severe neurologic impairment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT06075797 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the feasibility of the PQ-ResPOND intervention compared to usual care for managing recurrent pain in children, adolescents, and young adults with severe neurologic impairment. Participants will complete surveys regarding their pain and symptoms, while a subset will receive the PQ-ResPOND intervention, which utilizes a web platform to engage parents and providers in addressing the child's pain. The study seeks to determine both the feasibility of conducting a larger trial and the potential effectiveness of the intervention in alleviating pain.
Who should consider this trial
Good fit: Ideal candidates include children aged 1 year and older with severe neurologic impairment who are receiving ongoing care at Boston Children's Hospital.
Not a fit: Patients who are already under the care of a palliative care team or are not expected to survive at least two months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for children with severe neurologic impairment, enhancing their quality of life.
How similar studies have performed: While there is limited research specifically targeting pain management in this population, similar interventions in children with cancer have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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, and speak English OR Spanish
* are unable to understand and complete surveys.
Where this trial is running
Birmingham, Alabama and 3 other locations
- University of Alabama, Birmingham — Birmingham, Alabama, United States (Active_not_recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Active_not_recruiting)
- Deakin University — Burwood, Victoria, Australia (Active_not_recruiting)
Study contacts
- Principal investigator: Joanne Wolfe, MD, MPH — Massachusetts General Hospital
- Study coordinator: Madeline E Avery, MPH
- Email: meavery@mgh.harvard.edu
- Phone: 617 643 8846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.