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Ready for Change: Enhancing Motivational Engagement Prior to IIPT (PREPaRe)

Primary Purpose

Chronic Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MET-based therapy
Standard Care
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, pediatric

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient age 8-18 at enrollment
  • Presence of chronic pain condition for > 3 months with moderate or severe disability
  • Accepts referral to PPRC and awaiting admission

Exclusion Criteria:

  • Non-English speaking
  • No access to device with telehealth capability

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Standard Care

Arm Description

Receive motivational enhancement training based, telehealth-delivered 6-8 session intervention aimed at increasing readiness to engage in pain self-management, in addition to all recommended outpatient treatments.

Participate in all recommended outpatient pain treatments while awaiting PPRC admission.

Outcomes

Primary Outcome Measures

Length of stay
length of stay in PPRC program (in days)
Functional disability inventory (FDI) total score
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Functional disability inventory (FDI) total score
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Functional disability inventory (FDI) total score
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Pain stages of change questionnaire for adolescents (PSOCQ-A)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Modified Adolescent Treatment Engagement Questionnaire
Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.
Treatment satisfaction inventory
Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction

Secondary Outcome Measures

Pain intensity
pain intensity on 0-10 numeric scale (10=worst pain)
Pain intensity
pain intensity on 0-10 numeric scale (10=worst pain)
Pain intensity
pain intensity on 0-10 numeric scale (10=worst pain)
Pain intensity
pain intensity on 0-10 numeric scale (10=worst pain)
Chronic Pain Acceptance Questionnaire total score
Secondary measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.
Chronic Pain Acceptance Questionnaire total score
Secondary measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.
Committed action questionnaire total score
Secondary measure of readiness to change/engage in pain self-management. 8 item questionnaire with range 0-48. Higher scores indicate more committed action.
Committed action questionnaire
Secondary measure of readiness to change/engage in pain self-management. 8 item questionnaire with range 0-48. Higher scores indicate more committed action/readiness.

Full Information

First Posted
September 10, 2019
Last Updated
October 9, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04093921
Brief Title
Ready for Change: Enhancing Motivational Engagement Prior to IIPT
Acronym
PREPaRe
Official Title
Ready for Change: A Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program.
Detailed Description
Readiness to change, or willingness to engage in a self-management approach to chronic pain and disability, is the most powerful predictor of children's success in intensive pediatric pain rehabilitation. Motivational Enhancement Therapy (MET) is an approach that has been effective in increasing readiness to change and treatment engagement for other behaviorally-oriented health interventions. However, MET has never been systemically employed in the context of treating pediatric chronic pain and disability. This demonstration project seeks to test the effects of a novel telehealth intervention using motivation enhancement therapy to improve patient and parent engagement in, and outcomes of, an intensive interdisciplinary day hospital program for children with complex chronic pain conditions and associated disability, the Pediatric Pain Rehabilitation Center (PPRC). The intervention, PPRC-Prep, is a 4 week MET-based telehealth intervention that will be offered to families of children with refractory chronic pain conditions awaiting admission to the PPRC at Boston Children's Hospital at Waltham. Families approved for and awaiting PPRC admission will be randomized to receive PPRC-Prep along with usual care or to a comparison group receiving treatment as usual. Study aims include assessing the feasibility and acceptability of the intervention along with measuring its potential to increase readiness to engage in a self-management approach assessed at time of admission to the PPRC using established measures of readiness to change, pain acceptance, and committed action. Investigators will also evaluate the effects of PPRC-Prep on program length of stay and on reductions of disability and pain at PPRC discharge and short-term (8-week) follow up through comparison of families who undergo PPRC-prep with families who do not undergo PPRC-prep. Demonstrating the feasibility and preliminary effectiveness of PPRC-Prep will enable the study team to establish this as a routine component of our approach to care for children with complex, refractory chronic pain and disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Those providing care at the PPRC will not know which study arm their patients were in.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receive motivational enhancement training based, telehealth-delivered 6-8 session intervention aimed at increasing readiness to engage in pain self-management, in addition to all recommended outpatient treatments.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Participate in all recommended outpatient pain treatments while awaiting PPRC admission.
Intervention Type
Behavioral
Intervention Name(s)
MET-based therapy
Intervention Description
see previous
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
To include all recommended outpatient treatments
Primary Outcome Measure Information:
Title
Length of stay
Description
length of stay in PPRC program (in days)
Time Frame
PPRC discharge [within 6 months of baseline]
Title
Functional disability inventory (FDI) total score
Description
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Time Frame
at PPRC discharge [within 6 months of baseline]
Title
Functional disability inventory (FDI) total score
Description
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Time Frame
at PPRC follow up (4-8 weeks post discharge)
Title
Functional disability inventory (FDI) total score
Description
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Time Frame
at PPRC follow up (1 year post discharge)
Title
Pain stages of change questionnaire for adolescents (PSOCQ-A)
Description
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Time Frame
PPRC admission (within 2 months of baseline)
Title
Pain stages of change questionnaire for adolescents (PSOCQ-A)
Description
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Time Frame
PPRC discharge [within 6 months of baseline]
Title
Pain stages of change questionnaire for adolescents (PSOCQ-A)
Description
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Time Frame
at PPRC follow up (4-8 weeks post discharge)
Title
Pain stages of change questionnaire for adolescents (PSOCQ-A)
Description
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Time Frame
at PPRC follow up (1 year post discharge)
Title
Modified Adolescent Treatment Engagement Questionnaire
Description
Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.
Time Frame
At end of intervention, 4 weeks from baseline
Title
Treatment satisfaction inventory
Description
Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction
Time Frame
At end of intervention, 4 weeks from baseline
Secondary Outcome Measure Information:
Title
Pain intensity
Description
pain intensity on 0-10 numeric scale (10=worst pain)
Time Frame
At PPRC admission (4-6 weeks post baseline)
Title
Pain intensity
Description
pain intensity on 0-10 numeric scale (10=worst pain)
Time Frame
At PPRC discharge [within 6 months of baseline]
Title
Pain intensity
Description
pain intensity on 0-10 numeric scale (10=worst pain)
Time Frame
At first post-treatment follow up (4-8 weeks post discharge)
Title
Pain intensity
Description
pain intensity on 0-10 numeric scale (10=worst pain)
Time Frame
1 year post-treatment
Title
Chronic Pain Acceptance Questionnaire total score
Description
Secondary measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.
Time Frame
At PPRC admission [typically within 3 months of baseline]
Title
Chronic Pain Acceptance Questionnaire total score
Description
Secondary measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.
Time Frame
At PPRC discharge [within 6 months of baseline]
Title
Committed action questionnaire total score
Description
Secondary measure of readiness to change/engage in pain self-management. 8 item questionnaire with range 0-48. Higher scores indicate more committed action.
Time Frame
At PPRC admission [typically within 3 months of baseline]
Title
Committed action questionnaire
Description
Secondary measure of readiness to change/engage in pain self-management. 8 item questionnaire with range 0-48. Higher scores indicate more committed action/readiness.
Time Frame
At PPRC discharge [within 6 months of baseline]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient age 8-18 at enrollment Presence of chronic pain condition for > 3 months with moderate or severe disability Accepts referral to PPRC and awaiting admission Exclusion Criteria: Non-English speaking No access to device with telehealth capability
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a pilot study and we do not think the data should be shared.
Citations:
PubMed Identifier
36188162
Citation
Smith AM, Logan DE. Promoting readiness and engagement in pain rehabilitation for youth and families: Developing a pediatric telehealth motivational interviewing protocol. Paediatr Neonatal Pain. 2021 Oct 28;4(3):125-135. doi: 10.1002/pne2.12063. eCollection 2022 Sep.
Results Reference
derived

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Ready for Change: Enhancing Motivational Engagement Prior to IIPT

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