Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,333
- 试验地点
- 8
- 主要终点
- Achieving minimal clinically important difference (MCID) in pain severity at 3 months (yes/no)
研究概览
简要总结
The RESOLVE study is a multicenter comparative effectiveness trial of two cognitive behavioral therapy-based chronic pain (CBT-CP) treatments delivered via telehealth modalities: 1) online program and 2) live, health coach-led, virtual sessions (telephone and/or video conference).
详细描述
Specific Aims Aim #1: Determine the effectiveness of an online, CBT-based pain management program and virtual coach-led (telephonic/video) CBT-CP on achieving clinically meaningful improvements in patients' pain severity (pain intensity + pain-related interference) relative to those receiving usual care at 3 months.
1a. Examine the impact of the active interventions on secondary pain outcomes and related quality of life outcomes (social role functioning, physical functioning, and patient global impression of change); as well as exploratory outcomes, which include long-term opioid use; comorbid symptomology (depression, anxiety, and sleep disturbance); and high impact chronic pain and graded chronic pain.
1b. Conduct subgroup analyses to determine the impact of the active interventions on specific populations and explore for potential heterogeneity of treatment effects by sex; rural/medically underserved residency; multiple pain conditions; mental health mood disorders; and negative social determinants of health.
1c. Examine the role of theory-based mediators, pain catastrophizing, pain-related self-efficacy, and perceived support, on pain-severity.
Aim #2: Assess the cost and incremental cost-effectiveness of the online and virtual coach-led CBT-CP interventions compared to each other and usual care.
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 (Outcomes Assessor)
盲法说明
Primary and secondary outcome assessors will be masked to treatment assignment. It is not feasible for participants to be masked to treatment arm assignment due to the type of intervention. The PI and select Co-Investigators and study staff who are involved in the oversight and delivery of the interventions will also be aware of treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Electronic Health Record-based inclusion criteria:
- •Active/enrolled in one of the 4 participating integrated health care systems at the time of query and for the prior 360 days
- •Age 18 years or older (based on date of birth documented in EHR)
- •English speaking or do not need interpreter services
- •Have at least one [at Essentia] or at least two which are >60 days apart [at KP sites] outpatient pain-related health care encounter with nonmalignant musculoskeletal pain diagnoses [as determined by ICD10 codes for any of the following: back-neck-, limb/extremity-, joint-pain, arthritic disorders, fibromyalgia, headache, orofacial/temporomandibular pain, or musculoskeletal pain] within the past 360 days
- •Do not have an encounter for surgery related to common musculoskeletal pain conditions (e.g., joint replacement, spinal fusion, carpal tunnel release surgery) [as determined by CPT and/or ICD-10 codes] within the past 60 days
- •Do not have two or more separate encounters with a malignant cancer diagnosis other than non-melanoma skin cancer [as determined by ICD-10 codes] within past 60 days
- •Do not have ICD-10 code(s), Current Procedural Terminology (CPT) code(s) or department/provider encounters indicating receipt of hospice or other palliative care within the past 360 days
- •Do not have ICD-10 codes indicating severe cognitive impairment precluding participation in a behavioral/ lifestyle change program
- •Note: At the KPWA site only, one additional EHR-based exclusion criterion will be applied, which is: Do not have ICD-10 codes indicating opioid use disorder (OUD). This criterion is being applied because there is another HEAL study being conducted at KPWA that focuses on treating individuals with pain and OUD specifically.]
- •Patient-reported inclusion criteria:
- •Have high-impact chronic pain (as indicated by self-report of having pain on most or every day in past 3 months and pain limiting life or work activities on most or every day in past 3 months)
- •Have persistent pain (as indicated by self-report Pain, Enjoyment of Life and General Activity (PEG) score of ≥ 12)
- •Be able to participate in either of the active interventions (i.e., have internet and phone access required for accessing treatments)
排除标准
- •(patient-reported):
- •Have received CBT for pain or pain-related psychoeducation or behavioral skills training within in the past 6 months (in-person, by phone or videoconference, or online)
- •Currently receiving or will be starting CBT for pain or pain-related psychoeducation or behavioral skills training in the next month (in-person, by phone or videoconference, or online)
- •Currently receiving or will be starting inpatient or intensive outpatient services for substance use disorder in the next month
- •Have a planned/scheduled surgery in next 12 months related to pain condition
结局指标
主要结局
Achieving minimal clinically important difference (MCID) in pain severity at 3 months (yes/no)
时间窗: Baseline to 3 months
Minimal clinically important difference (MCID) in pain severity is defined as a 30% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) guidelines) (binary). Range: 0 to 10. Higher score = worse pain severity.
次要结局
- Social role functioning(Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months)
- Physical functioning(Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months)
- Cost and incremental cost-effectiveness(Patient health care utilization costs from baseline to 12 months)
- Achieving MCID in pain severity at 6 and 12 months (yes / no)(Baseline to 6 and 12 months)
- Pain severity(Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months)
- Pain-related interference(Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months)
- Pain intensity(Baseline to 3, 6, and 12 months)
- Patient global impression of change (PGIC)(Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months)