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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Standard Care | Active Comparator | Participate in all recommended outpatient pain treatments while awaiting PPRC admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MET-based therapy | Behavioral | see previous |
| |
| Standard Care |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | length of stay in PPRC program (in weeks) | PPRC discharge [within 6 months of baseline] |
| Functional disability inventory (FDI) total score | level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability | at PPRC follow up (4-8 weeks post discharge) |
| 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. | PPRC admission (within 2 months of baseline) |
| 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. | PPRC discharge [within 6 months of baseline] |
| 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. | at PPRC follow up (4-8 weeks post discharge) |
| 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. | at PPRC follow up (1 year post discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | pain intensity on 0-10 numeric scale (10=worst pain) | At PPRC admission (4-6 weeks post baseline) |
| Pain intensity | pain intensity on 0-10 numeric scale (10=worst pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36188162 | Derived | 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. |
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THis is a very small, early phase RCT. There may be specific circumstances in which it would be appropriate to share our data. We welcome contact from investigators in the area of pediatric pain and would work to determine best sharing practices if relevant. All data would be de-identified.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Those providing care at the PPRC will not know which study arm their patients were in.
| Behavioral |
To include all recommended outpatient treatments |
|
| Modified Adolescent Treatment Engagement Questionnaire | Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement. | At end of intervention, 4 weeks from baseline |
| Chronic Pain Acceptance Questionnaire total score | 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. | At PPRC discharge [within 6 months of baseline] |
| Chronic Pain Acceptance Questionnaire total score | 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. | At PPRC admission [typically within 3 months of baseline] |
| Treatment satisfaction inventory | Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction | At end of intervention, 4 weeks from baseline |
| Readiness Rulers | Motivational interviewing based ratings of willingness, importance, awareness and confidence related to adopting a self-management approach to pain | During and at end of the intervention, for the treatment group only |
| At PPRC discharge [within 6 months of baseline] |
| Functional disability inventory (FDI) total score | level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability | at PPRC discharge [within 6 months of baseline] |
| Functional disability inventory (FDI) total score | level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability | at PPRC follow up (1 year post discharge) |
| Pain intensity | pain intensity on 0-10 numeric scale (10=worst pain) | At first post-treatment follow up (4-8 weeks post discharge) |
| Pain intensity | pain intensity on 0-10 numeric scale (10=worst pain) | 1 year post-treatment |
| 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. | At PPRC admission [typically within 3 months of baseline] |
| 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. | At PPRC discharge [within 6 months of baseline] |
| Parental pain catastrophizing | Measure of parents' negative thoughts related to child's pain | At treatment admission and discharge, following intervention/control period |
| Adult responses to child pain - protect subscale | Parental protective responses to child pain behaviors | At treatment admission and discharge, following intervention/control period |
| Parental fear of pain questionnaire | Parent report of pain related fears/worries | At treatment admission and discharge, following intervention/control period |