Ready for Change: a Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Treatment satisfaction inventory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Those providing care at the PPRC will not know which study arm their patients were in.
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-English speaking
- •No access to device with telehealth capability
研究组 & 干预措施
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.
干预措施: MET-based therapy (Behavioral)
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.
干预措施: Standard Care (Behavioral)
Standard Care
Participate in all recommended outpatient pain treatments while awaiting PPRC admission.
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Treatment satisfaction inventory
时间窗: At end of intervention, 4 weeks from baseline
Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction
Length of stay
时间窗: PPRC discharge [within 6 months of baseline]
length of stay in PPRC program (in weeks)
Pain stages of change questionnaire for adolescents (PSOCQ-A)
时间窗: 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.
Chronic Pain Acceptance Questionnaire total score
时间窗: At PPRC admission [typically within 3 months of baseline]
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.
Functional disability inventory (FDI) total score
时间窗: 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
Readiness Rulers
时间窗: During and at end of the intervention, for the treatment group only
Motivational interviewing based ratings of willingness, importance, awareness and confidence related to adopting a self-management approach to pain
Modified Adolescent Treatment Engagement Questionnaire
时间窗: At end of intervention, 4 weeks from baseline
Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
时间窗: 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.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
时间窗: 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.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
时间窗: 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.
Chronic Pain Acceptance Questionnaire total score
时间窗: At PPRC discharge [within 6 months of baseline]
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.
次要结局
- Pain intensity(1 year post-treatment)
- Functional disability inventory (FDI) total score(at PPRC follow up (1 year post discharge))
- Committed action questionnaire total score(At PPRC admission [typically within 3 months of baseline])
- Committed action questionnaire(At PPRC discharge [within 6 months of baseline])
- Parental pain catastrophizing(At treatment admission and discharge, following intervention/control period)
- Adult responses to child pain - protect subscale(At treatment admission and discharge, following intervention/control period)
- Parental fear of pain questionnaire(At treatment admission and discharge, following intervention/control period)
- Pain intensity(At PPRC admission (4-6 weeks post baseline))
- Pain intensity(At PPRC discharge [within 6 months of baseline])
- Functional disability inventory (FDI) total score(at PPRC discharge [within 6 months of baseline])
- Pain intensity(At first post-treatment follow up (4-8 weeks post discharge))
研究者
Deirdre Logan
Director of psychology services in pain medicine
Boston Children's Hospital