Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 608
- 试验地点
- 8
- 主要终点
- Pain Interference - Brief Pain Inventory (BPI)
研究概览
简要总结
This is a randomized controlled trial comparing the effectiveness of a remotely delivered collaborative care intervention for chronic pain versus a minimally enhanced control group. The specific aims of the study are: (1) compare the effectiveness of tele-collaborative pain care vs. minimally enhanced usual care to improve pain interference over 12 months of follow-up, and (2) oversample women and rural veterans of minoritized race/ethnicity to test heterogeneity of treatment effects across birth sex and race/ethnicity.
详细描述
The CORPs trial is a multisite pragmatic effectiveness trial taking place at four geographically diverse VA sites. The CORPs trial will assess the effectiveness of a nurse-led tele-collaborative pain care intervention (CORPs) compared to a one-time education session with a nurse (minimally enhanced usual care, or MEUC) at improving pain and health outcomes for Veterans living in rural areas. This study focuses on management of pain with non-medication services and therapies.
Veterans who enroll will participate for 12-months and will be randomized to one of 2 groups: 1) CORPs (with access to a nurse by phone/video for the duration of the study), or 2) One-time education session with the nurse by phone/video to review resources for pain. All participants complete research assessments at the start of the study, and at 3-, 6-, 9-, and 12-months by phone.
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)
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
- •U.S. Veteran
- •Rural Residence based on Rural Urban Commuting Area codes
- •High Impact Chronic pain, determined through a phone screening
- •Access to landline or cell phone
- •English Speaking
排除标准
- •Cognitive impairment that would impact participation in the study
- •Plans to move in the next 3 months
- •Surgery in the past 3 months
- •In long-term inpatient or hospice care
- •Terminal illness (defined as life expectancy of less than 12 months)
- •Active participation in another pain intervention study
研究组 & 干预措施
CORPs Intervention
The CORPs Intervention is a nurse-led intervention.
A) An intake assessment with a Nurse Care Manager at the start of the study by phone or video to discuss the patient's pain experience, care options, and goals. Resources are provided and focus on non-medication options at the VA, and as appropriate, in the community.
B) 5 Check-in phone/video appointments with a Nurse Care Manager, scheduled to take place near 2-, 4-, 8-, 12-, and 16-weeks. These visits will provide further assistance with goal planning and care coordination for pain management.
C) Optional 6-week virtual group education class covering topics like complementary and integrative approaches to pain, sleep and pain, and the neurobiology of pain.
D) Patients in this arm can contact their nurse with questions for the full 12 months of participation.
干预措施: CORPs Intervention (Behavioral)
Minimally Enhanced Usual Care (MEUC)
The minimally enhanced usual care arm is a one-time education session.
A) One-time education session with a Nurse Care Manager by phone/video to review pain resources. These resources focus on non-medication options at the VA, and as appropriate, in the community.
干预措施: Minimally Enhanced Usual Care (MEUC) (Behavioral)
结局指标
主要结局
Pain Interference - Brief Pain Inventory (BPI)
时间窗: Baseline, 3-, 6-, 9-, and 12 Months
Pain Interference subscale from the Brief Pain Inventory. Scores are reported on a range of 0 - 10, with higher scores indicating more impairment due to pain.
次要结局
- Quality of Life - Veterans RAND-12 (VR-12)(Baseline, 3-, 6-, 9-, and 12 Months)
- Quality of Sleep - PROMIS Sleep Disturbance Scale(Baseline, 3-, 6-, 9-, and 12 Months)
- Physical Functioning - PROMIS Physical Functioning Scale(Baseline, 3-, 6-, 9-, and 12 Months)
- Anxiety Symptoms - Generalized Anxiety Disorder-7 (GAD-7)(Baseline, 3-, 6-, 9-, and 12 Months)
- Engagement in Non-Pharmacological Services/Treatments - Nonpharmacological Self-Care Approaches survey (NSCAP)(Baseline, 3-, 6-, 9-, and 12 Months)
- Pain Intensity - Brief Pain Inventory (BPI)(Baseline, 3-, 6-, 9-, and 12 Months)
- Depressive Symptoms - Patient Health Questionnaire-9 (PHQ-9)(Baseline, 3-, 6-, 9-, and 12 Months)
- Suicidal Behavior - Electronic Health Record (EHR)(Baseline, 3-, 6-, 9-, and 12 Months)
研究者
Travis Lovejoy
Principal Investigator
Oregon Health and Science University