Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Oregon Health and Science University
- Enrollment
- 608
- Locations
- 4
- Primary Endpoint
- Pain Interference - Brief Pain Inventory (BPI)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Travis Lovejoy
Principal Investigator
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Pain Interference - Brief Pain Inventory (BPI)
Time Frame: 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.
Secondary Outcomes
- 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)