PPRC-Prep: Ready for Change: A Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation

Sponsor
Boston Children's Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04093921
Collaborator
(none)
80
1
2
32.5
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MET-based therapy
  • Behavioral: Standard Care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Masking Description:
Those providing care at the PPRC will not know which study arm their patients were in.
Primary Purpose:
Treatment
Official Title:
Ready for Change: A Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation
Actual Study Start Date :
Jun 15, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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.

Behavioral: MET-based therapy
see previous

Behavioral: Standard Care
To include all recommended outpatient treatments

Active Comparator: Standard Care

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

Behavioral: Standard Care
To include all recommended outpatient treatments

Outcome Measures

Primary Outcome Measures

  1. Length of stay [PPRC discharge [within 6 months of baseline]]

    length of stay in PPRC program (in days)

  2. Functional disability inventory (FDI) total score [at PPRC discharge [within 6 months of baseline]]

    level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability

  3. Functional disability inventory (FDI) total score [at PPRC follow up (4-8 weeks post discharge)]

    level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability

  4. Functional disability inventory (FDI) total score [at PPRC follow up (1 year post discharge)]

    level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability

  5. Pain stages of change questionnaire for adolescents (PSOCQ-A) [PPRC admission (within 2 months of baseline)]

    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.

  6. Pain stages of change questionnaire for adolescents (PSOCQ-A) [PPRC discharge [within 6 months of baseline]]

    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.

  7. Pain stages of change questionnaire for adolescents (PSOCQ-A) [at PPRC follow up (4-8 weeks post discharge)]

    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.

  8. Pain stages of change questionnaire for adolescents (PSOCQ-A) [at PPRC follow up (1 year post discharge)]

    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.

  9. Modified Adolescent Treatment Engagement Questionnaire [At end of intervention, 4 weeks from baseline]

    Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.

  10. Treatment satisfaction inventory [At end of intervention, 4 weeks from baseline]

    Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction

Secondary Outcome Measures

  1. Pain intensity [At PPRC admission (4-6 weeks post baseline)]

    pain intensity on 0-10 numeric scale (10=worst pain)

  2. Pain intensity [At PPRC discharge [within 6 months of baseline]]

    pain intensity on 0-10 numeric scale (10=worst pain)

  3. Pain intensity [At first post-treatment follow up (4-8 weeks post discharge)]

    pain intensity on 0-10 numeric scale (10=worst pain)

  4. Pain intensity [1 year post-treatment]

    pain intensity on 0-10 numeric scale (10=worst pain)

  5. Chronic Pain Acceptance Questionnaire total score [At PPRC admission [typically within 3 months of baseline]]

    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.

  6. Chronic Pain Acceptance Questionnaire total score [At PPRC discharge [within 6 months of baseline]]

    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.

  7. Committed action questionnaire total score [At PPRC admission [typically within 3 months of baseline]]

    Secondary measure of readiness to change/engage in pain self-management. 8 item questionnaire with range 0-48. Higher scores indicate more committed action.

  8. Committed action questionnaire [At PPRC discharge [within 6 months of baseline]]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deirdre Logan, Director of psychology services in pain medicine, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT04093921
Other Study ID Numbers:
  • P00033150
First Posted:
Sep 18, 2019
Last Update Posted:
Nov 5, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Deirdre Logan, Director of psychology services in pain medicine, Boston Children's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2021