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The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial
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.
Study details:
Background: In the US, tens of thousands of children, adolescents, and young adults (AYA) are estimated to live with severe neurologic impairment (SNI). Over 60% of these children endure uncontrolled and often persistent pain, which frequently goes unrecognized and untreated. The impact extends to their parents who commonly experience unremitting physical and psychological distress.
There has been a lack of rigorous studies that focus on interventions to alleviate recurrent pain in children with SNI. This gap might be attributed to the stigmatization of these children, who are often from historically marginalized backgrounds, resulting in a low prioritization in research endeavors. To address this inequity and using the ORBIT Model for intervention development, the investigators have adapted and are refining an intervention previously applied in children with cancer.
The PediQUEST Response to Pain Of children with Neurologic Disability (PQ-ResPOND) will respond to child distress by using "reciprocal activation" strategies to overcome normalization-the acceptance among parents and clinicians that symptom distress is an unavoidable outcome of serious illness-and integration of a specialty pediatric palliative care team (PPC). The overall objective of the study is to evaluate the feasibility of running a full-scale RCT that compares the effect of the PediQUEST ResPOND intervention vs. usual care in children and AYA with SNI.
Specific Aims are to 1. assess study's feasibility and acceptability by evaluating recruitment (rates and suitability of screening/tracking), adherence to the intervention (by study participants and interventionists), and retention (dropout rates, reasons, and demographics); and, 2. explore potential for intervention's efficacy by estimating effect sizes and variability of the outcomes proposed for the full-scale RCT (child recurrent pain and symptom burden, and parent outcomes) and assessing intervention's acceptability through semi-structured interviews.
Methods: Researchers will conduct a single site Phase II Pilot 2:1 RCT of PQ-ResPOND (intervention, n=30) vs. usual care (control, n=15) in 45 children ≥1 year-old \& AYA with SNI and moderate to severe recurrent pain behaviors. After randomization, participants will answer weekly PQ-ResPOND surveys and monthly outcome surveys over 12 weeks via the PQ App, and a semi-structured exit interview.
Intervention: participants assigned to this arm will receive the PQ-ResPOND intervention which combines (i) parent-mediated activation through weekly collection and feedback to parents and clinicians, via our PQ App, of parent reported child pain (Non-Communicating Children's Pain Checklist-Revised scale (NCCPC-R)) and other symptoms (PediQUEST-Memorial Symptom Assessment Scale adapted for children with SNI), with (ii) PPC team-mediated activation of primary clinicians and parents: through PPC consultation, and (iii) PPC team activation through training in a standardized approach to recurrent pain using the PQ-ResPOND Checklist (adapted by the study's interprofessional expert panel). Usual care: participants in this arm will continue receiving care as usual. Outcomes: Investigators will use quantitative and qualitative outcomes to study feasibility and acceptability including recruitment and retention rates, intermittent attrition, adherence to intervention delivery by clinicians, and participant and clinician's acceptability of the intervention.
To preliminarily estimate effect sizes and variability, the corresponding scores for child's pain and symptom burden, and parent distress and activation measures will be estimated. Analysis: For feasibility and acceptability quantitative outcomes investigators will use descriptive statistics. Demographics and reasons for attrition will be reported to explore potential for selection bias.
A focused thematic analysis will be used to analyze qualitative variables. To estimate effect sizes and variability of trial outcomes, mixed linear regression models will be estimated. A predefined set of progression criteria are in place.
Discussion: Results will inform whether a full-scale Phase III RCT is warranted, and will help with study design and sample size calculation, development of a manual of procedures and fidelity monitoring strategies.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 1 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-05-08
Primary completion: 2025-05-30
Study completion finish: 2025-07-15
Study type
OTHER
Phase
NA
Trial ID
NCT06075797
Intervention or treatment
BEHAVIORAL: PediQUEST ResPOND
Conditions
- • Cerebral Palsy Infantile
- • Disabilities Multiple
- • Pain
Find a site
Closest Location:
Deakin University
Research sites nearby
Select from list below to view details:
Deakin University
Burwood, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: PQ-ResPOND (Intervention)
| BEHAVIORAL: PediQUEST ResPOND
|
NO_INTERVENTION: Usual care (Control)
| Not specified |
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Recruitment rate | Proportion of contacted potential participants meeting initial inclusion criteria who consent to participate | 16 months |
| Recruitment/month | Number of participants recruited per month | 16 months |
| Randomization rate | Proportion of enrolled participants who meet randomization criteria (moderate to severe pain) | 16 months |
| Suitability of screening/tracking | Qualitative outcome: As reported by research staff and site investigators involved in patient validation | 16 months |
| Sample diversity | Proportion of enrolled participants by race/ ethnicity | 16 months |
| Refusal reasons | Qualitative: Description of reasons for refusal mentioned in the consent conversation or non-participation survey | 16 months |
| Dropout rate | Proportion of enrolled participants who dropout from the study | 16 months |
| Demographics of dropouts | Proportion of dropout participants by race/ ethnicity | 16 months |
| Dropout reasons | Description of dropout reasons referred by participants during exit interview or dropout conversation | 16 months |
| Intermittent attrition | Surveys' response rates and distribution of non-responses will be used to determine participant's adherence with study data collection procedures | 16 months |
| Adherence with answering surveys | Qualitative: Parent perspectives on survey frequency, length, relevance, and burden | 16 months |
| Feasibility of intervention delivery | 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. | 16 months |
| Participant's acceptability of the intervention | Satisfaction with the intervention measured through a numerical 0-10 rating score | At week 12 |
| Likelihood that participants would recommend study to others | Agreement with recommending the study to others using a numeric 0-10 rating score | At week 12 |
| Participant's acceptability of intervention (qualitative) | Qualitative: We will explore participant's views on the intervention during exit interviews | At week 12 |
| Clinician's acceptability of intervention (qualitative) | 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) | 16 months |
| Participant's overall satisfaction with the study | We will analyze participant's overall satisfaction with the study on a 0 to 10 numeric scale | At study exit |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Child pain | 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) | 12 weeks |
| Child symptom burden | 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. | 12 weeks |
| Parent Anxiety | 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. | 12 weeks |
| Parent Depression | 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). | 12 weeks |
| Parent Pain-related Stress | 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. | 12 weeks |
| Parent overall health quality | 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. | 12 weeks |
| Parent sleep quality - total sleep time | 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. | 12 weeks |
| Parent sleep quality - refreshing sleep | 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. | 12 weeks |
| Use of Complementary Therapies | 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. | 12 weeks |
| Parent Coping - Active coping | 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. | 12 weeks |
| Parent Coping - Planning | 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. | 12 weeks |
| Parent Coping - Instrumental support | 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. | 12 weeks |
| Parent Coping - Acceptance | 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. | 12 weeks |
| Parent Coping - Self-blame | 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. | 12 weeks |
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