Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06075797
Registration number
NCT06075797
Ethics application status
Date submitted
26/09/2023
Date registered
10/10/2023
Date last updated
21/05/2024
Titles & IDs
Public title
The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial
Query!
Scientific title
Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)
Query!
Secondary ID [1]
0
0
1R21NR020433
Query!
Secondary ID [2]
0
0
2023p002305
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PQ-ResPOND
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy Infantile
0
0
Query!
Disabilities Multiple
0
0
Query!
Pain
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Behaviour - 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.
Behaviour: 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.
Query!
Intervention code [1]
0
0
Behaviour
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Recruitment rate
Query!
Assessment method [1]
0
0
Proportion of contacted potential participants meeting initial inclusion criteria who consent to participate
Query!
Timepoint [1]
0
0
16 months
Query!
Primary outcome [2]
0
0
Recruitment/month
Query!
Assessment method [2]
0
0
Number of participants recruited per month
Query!
Timepoint [2]
0
0
16 months
Query!
Primary outcome [3]
0
0
Randomization rate
Query!
Assessment method [3]
0
0
Proportion of enrolled participants who meet randomization criteria (moderate to severe pain)
Query!
Timepoint [3]
0
0
16 months
Query!
Primary outcome [4]
0
0
Suitability of screening/tracking
Query!
Assessment method [4]
0
0
Qualitative outcome: As reported by research staff and site investigators involved in patient validation
Query!
Timepoint [4]
0
0
16 months
Query!
Primary outcome [5]
0
0
Sample diversity
Query!
Assessment method [5]
0
0
Proportion of enrolled participants by race/ ethnicity
Query!
Timepoint [5]
0
0
16 months
Query!
Primary outcome [6]
0
0
Refusal reasons
Query!
Assessment method [6]
0
0
Qualitative: Description of reasons for refusal mentioned in the consent conversation or non-participation survey
Query!
Timepoint [6]
0
0
16 months
Query!
Primary outcome [7]
0
0
Dropout rate
Query!
Assessment method [7]
0
0
Proportion of enrolled participants who dropout from the study
Query!
Timepoint [7]
0
0
16 months
Query!
Primary outcome [8]
0
0
Demographics of dropouts
Query!
Assessment method [8]
0
0
Proportion of dropout participants by race/ ethnicity
Query!
Timepoint [8]
0
0
16 months
Query!
Primary outcome [9]
0
0
Dropout reasons
Query!
Assessment method [9]
0
0
Description of dropout reasons referred by participants during exit interview or dropout conversation
Query!
Timepoint [9]
0
0
16 months
Query!
Primary outcome [10]
0
0
Intermittent attrition
Query!
Assessment method [10]
0
0
Surveys' response rates and distribution of non-responses will be used to determine participant's adherence with study data collection procedures
Query!
Timepoint [10]
0
0
16 months
Query!
Primary outcome [11]
0
0
Adherence with answering surveys
Query!
Assessment method [11]
0
0
Qualitative: Parent perspectives on survey frequency, length, relevance, and burden
Query!
Timepoint [11]
0
0
16 months
Query!
Primary outcome [12]
0
0
Feasibility of intervention delivery
Query!
Assessment method [12]
0
0
Qualitative: Using information from the PQ system, medical records, and exit interviews we will assess how feasible it is to deliver the different intervention components.
Query!
Timepoint [12]
0
0
16 months
Query!
Primary outcome [13]
0
0
Participant's acceptability of the intervention
Query!
Assessment method [13]
0
0
Satisfaction with the intervention measured through a numerical 0-10 rating score
Query!
Timepoint [13]
0
0
At week 12
Query!
Primary outcome [14]
0
0
Likelihood that participants would recommend study to others
Query!
Assessment method [14]
0
0
Agreement with recommending the study to others using a numeric 0-10 rating score
Query!
Timepoint [14]
0
0
At week 12
Query!
Primary outcome [15]
0
0
Participant's acceptability of intervention (qualitative)
Query!
Assessment method [15]
0
0
Qualitative: We will explore participant's views on the intervention during exit interviews
Query!
Timepoint [15]
0
0
At week 12
Query!
Primary outcome [16]
0
0
Clinician's acceptability of intervention (qualitative)
Query!
Assessment method [16]
0
0
Qualitative: Clinicians views on the intervention will be explored during semi-structured clinician interviews (these will be conducted every 6 months with a subset of clinicians)
Query!
Timepoint [16]
0
0
16 months
Query!
Primary outcome [17]
0
0
Participant's overall satisfaction with the study
Query!
Assessment method [17]
0
0
We will analyze participant's overall satisfaction with the study on a 0 to 10 numeric scale
Query!
Timepoint [17]
0
0
At study exit
Query!
Secondary outcome [1]
0
0
Child pain
Query!
Assessment method [1]
0
0
This is the proposed primary outcome for future Phase III trial. All secondary outcomes will be used to preliminarily estimate effect sizes and help with sample size calculations. We will present estimates of effect, variability, and intraclass correlation coefficients with their 95% Confidence Intervals (95%CI).
Difference between intervention and control arms of the average Pediatric Pain Profile (PPP) most difficult day of last week scores over 12 weeks, measured monthly, as reported by the parent for all enrolled children. Score range: 0-60, higher scores indicate more pain. Cut off point for pain: 14 (>14 indicates pain)
Query!
Timepoint [1]
0
0
12 weeks
Query!
Secondary outcome [2]
0
0
Child symptom burden
Query!
Assessment method [2]
0
0
Difference between intervention and control arms of the average (PediQUEST ResPOND Memorial Symptom Assessment Scale, PQ-ResPOND MSAS) total scores over 12 weeks, as reported weekly by the parent. PQ-ResPOND MSAS total scores are calculated as the average of the 21 individual symptom scores. Individual symptom scores are calculated as the average of the three symptom questions. Individual symptom scores and total scores range from 0-100, 100 indicates higher symptom burden.
Query!
Timepoint [2]
0
0
12 weeks
Query!
Secondary outcome [3]
0
0
Parent Anxiety
Query!
Assessment method [3]
0
0
Difference between trial arms of the average Spielberger's-State Anxiety Inventory-State scores over 12 weeks, measured monthly. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Query!
Timepoint [3]
0
0
12 weeks
Query!
Secondary outcome [4]
0
0
Parent Depression
Query!
Assessment method [4]
0
0
Difference between trial arms of the mean Center for Epidemiologic Studies Short Depression Scale (CES-D-10) scores over 12 weeks. Scores range from 0 to 30 (Score of 10 or higher indicates the presence of significant depressive symptoms).
Query!
Timepoint [4]
0
0
12 weeks
Query!
Secondary outcome [5]
0
0
Parent Pain-related Stress
Query!
Assessment method [5]
0
0
Difference between trial arms of the mean pain-related stress scores measured with an adapted version of the stress-portion of the Response to Stress Questionnaire-Pain, measured monthly. The tool assesses 12 potential stress sources. Scores range from 1-4 (higher means more stress). Symptom-related stress score calculated as the sum of the 12 item scores.
Query!
Timepoint [5]
0
0
12 weeks
Query!
Secondary outcome [6]
0
0
Parent overall health quality
Query!
Assessment method [6]
0
0
Difference between trial arms of the mean overall health quality score measured monthly with one item of the Short Form (12) Health Survey (SF-12). Uses a 5 point Likert type scale and is scored 0-100, where 100 is excellent overall health.
Query!
Timepoint [6]
0
0
12 weeks
Query!
Secondary outcome [7]
0
0
Parent sleep quality - total sleep time
Query!
Assessment method [7]
0
0
Parent sleep quality will be measured with an adapted version of the Consensus Sleep Diary. Difference between trial arms of the mean overall score of the weekly average total sleep time (in hours), measured monthly. More hours of sleep is better.
Query!
Timepoint [7]
0
0
12 weeks
Query!
Secondary outcome [8]
0
0
Parent sleep quality - refreshing sleep
Query!
Assessment method [8]
0
0
Measured with an adapted version of the Consensus Sleep Diary. Difference between trial arms of the mean overall weekly score of the refreshing sleep item, measured monthly. Response options 1 to 5, where 5 is extremely refreshing.
Query!
Timepoint [8]
0
0
12 weeks
Query!
Secondary outcome [9]
0
0
Use of Complementary Therapies
Query!
Assessment method [9]
0
0
Difference between trial arms of the No. of complementary therapies used measured monthly with the Use of Complementary therapies checklist (developed ad hoc). Continuous variable, where higher numbers indicates more use of complementary therapies.
Query!
Timepoint [9]
0
0
12 weeks
Query!
Secondary outcome [10]
0
0
Parent Coping - Active coping
Query!
Assessment method [10]
0
0
Difference between trial arms of the mean overall active coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE).
Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Query!
Timepoint [10]
0
0
12 weeks
Query!
Secondary outcome [11]
0
0
Parent Coping - Planning
Query!
Assessment method [11]
0
0
Difference between trial arms of the mean planning coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE). Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Query!
Timepoint [11]
0
0
12 weeks
Query!
Secondary outcome [12]
0
0
Parent Coping - Instrumental support
Query!
Assessment method [12]
0
0
Difference between trial arms of the mean instrumental support coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE). Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Query!
Timepoint [12]
0
0
12 weeks
Query!
Secondary outcome [13]
0
0
Parent Coping - Acceptance
Query!
Assessment method [13]
0
0
Difference between trial arms of the mean acceptance coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE).
Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Query!
Timepoint [13]
0
0
12 weeks
Query!
Secondary outcome [14]
0
0
Parent Coping - Self-blame
Query!
Assessment method [14]
0
0
Difference between trial arms of the mean self-blame coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE). Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Query!
Timepoint [14]
0
0
12 weeks
Query!
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
Query!
Minimum age
1
Year
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/03/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
15/07/2025
Query!
Actual
Query!
Sample size
Target
60
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Deakin University - Burwood
Query!
Recruitment postcode(s) [1]
0
0
3125 - Burwood
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Massachusetts
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Massachusetts General Hospital
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Government body
Query!
Name [1]
0
0
National Institute of Nursing Research (NINR)
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Boston Children's Hospital
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Dana-Farber Cancer Institute
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
University of Alabama at Birmingham
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Other
Query!
Name [5]
0
0
Deakin University
Query!
Address [5]
0
0
Query!
Country [5]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06075797
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Joanne Wolfe, MD, MPH
Query!
Address
0
0
Massachusetts General Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Madeline E Avery, MPH
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
617 643 8846
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06075797
Download to PDF