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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06075797




Registration number
NCT06075797
Ethics application status
Date submitted
26/09/2023
Date registered
10/10/2023

Titles & IDs
Public title
The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial
Scientific title
Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)
Secondary ID [1] 0 0
1R21NR020433
Secondary ID [2] 0 0
2023p002305
Universal Trial Number (UTN)
Trial acronym
PQ-ResPOND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy Infantile 0 0
Disabilities Multiple 0 0
Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - PediQUEST ResPOND

Experimental: PQ-ResPOND (Intervention) - Participants in the intervention arm will (i) answer weekly PQ-ResPOND Surveys over 12 weeks, (ii) receive feedback reports (generated by the PediQUEST system to summarize parents answers), and (iii) engage with the pediatric palliative care (PPC) team.

The interprofessional PPC team will focus on child's recurrent pain and related symptoms using a standardized approach and work on family activation strategies.

No intervention: Usual care (Control) - Participants randomized to the control arm will be assigned weekly PQ-ResPOND Surveys up to week 12. Participants in this arm will not have access to the full PediQUEST system, i.e. no reports will be generated. They will not meet the PPC team but can receive regular palliative care consultations following the site's usual referral procedures.

Children in the usual care arm will receive standard care, which at Boston Children's Hospital usually involves several primary clinicians (primarily neurologists or Complex Care Service attending physicians) and access to psychosocial clinician care throughout the illness course. PPC referrals are typically made at the discretion of the primary clinician, often for decision making reasons and/or closer to end-of-life. If a child presents persistent distress, they will be cared through the usual mechanisms. The rationale for collecting weekly surveys is to minimize reporting bias and may increase adherence and retention.


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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recruitment rate
Timepoint [1] 0 0
16 months
Primary outcome [2] 0 0
Recruitment/month
Timepoint [2] 0 0
16 months
Primary outcome [3] 0 0
Randomization rate
Timepoint [3] 0 0
16 months
Primary outcome [4] 0 0
Suitability of screening/tracking
Timepoint [4] 0 0
16 months
Primary outcome [5] 0 0
Sample diversity
Timepoint [5] 0 0
16 months
Primary outcome [6] 0 0
Refusal reasons
Timepoint [6] 0 0
16 months
Primary outcome [7] 0 0
Dropout rate
Timepoint [7] 0 0
16 months
Primary outcome [8] 0 0
Demographics of dropouts
Timepoint [8] 0 0
16 months
Primary outcome [9] 0 0
Dropout reasons
Timepoint [9] 0 0
16 months
Primary outcome [10] 0 0
Intermittent attrition
Timepoint [10] 0 0
16 months
Primary outcome [11] 0 0
Adherence with answering surveys
Timepoint [11] 0 0
16 months
Primary outcome [12] 0 0
Feasibility of intervention delivery
Timepoint [12] 0 0
16 months
Primary outcome [13] 0 0
Participant's acceptability of the intervention
Timepoint [13] 0 0
At week 12
Primary outcome [14] 0 0
Likelihood that participants would recommend study to others
Timepoint [14] 0 0
At week 12
Primary outcome [15] 0 0
Participant's acceptability of intervention (qualitative)
Timepoint [15] 0 0
At week 12
Primary outcome [16] 0 0
Clinician's acceptability of intervention (qualitative)
Timepoint [16] 0 0
16 months
Primary outcome [17] 0 0
Participant's overall satisfaction with the study
Timepoint [17] 0 0
At study exit
Secondary outcome [1] 0 0
Child pain
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Child symptom burden
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Parent Anxiety
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Parent Depression
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Parent Pain-related Stress
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Parent overall health quality
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Parent sleep quality - total sleep time
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Parent sleep quality - refreshing sleep
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Use of Complementary Therapies
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Parent Coping - Active coping
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Parent Coping - Planning
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Parent Coping - Instrumental support
Timepoint [12] 0 0
12 weeks
Secondary outcome [13] 0 0
Parent Coping - Acceptance
Timepoint [13] 0 0
12 weeks
Secondary outcome [14] 0 0
Parent Coping - Self-blame
Timepoint [14] 0 0
12 weeks

Eligibility
Key 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
Minimum age
1 Year
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/07/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Deakin University - Burwood
Recruitment postcode(s) [1] 0 0
3125 - Burwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Massachusetts General Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Nursing Research (NINR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Boston Children's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Dana-Farber Cancer Institute
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Alabama at Birmingham
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Deakin University
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanne Wolfe, MD, MPH
Address 0 0
Massachusetts General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Madeline E Avery, MPH
Address 0 0
Country 0 0
Phone 0 0
617 643 8846
Fax 0 0
Email 0 0
meavery@mgh.harvard.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06075797