Tele-Collaborative Outreach to Rural Patients With Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Behavioral: CORPs InterventionBehavioral: Minimally Enhanced Usual Care (MEUC)
- Registration Number
- NCT06091202
- Lead Sponsor
- Oregon Health and Science University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 608
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CORPs Intervention 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. Minimally Enhanced Usual Care (MEUC) 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.
- Primary Outcome Measures
Name Time Method Pain Interference - Brief Pain Inventory (BPI) 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 Outcome Measures
Name Time Method Quality of Life - Veterans RAND-12 (VR-12) Baseline, 3-, 6-, 9-, and 12 Months Quality of Life will be assessed with the Veterans RAND 12-item Health Survey (VR-12). VR-12 scores are summarized into two scores, a Physical Health component score and a Mental Health component score. Each component score is on a range of 0 - 100, with higher scores indicating more impairment in physical or mental health, respectively.
Quality of Sleep - PROMIS Sleep Disturbance Scale Baseline, 3-, 6-, 9-, and 12 Months Quality of sleep will be assessed with the PROMIS Sleep Disturbance 4-item short-form. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome.
Physical Functioning - PROMIS Physical Functioning Scale Baseline, 3-, 6-, 9-, and 12 Months Physical Functioning will be assessed with the 4-item PROMIS Physical Functioning scale. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with one representing a better outcome.
Anxiety Symptoms - Generalized Anxiety Disorder-7 (GAD-7) Baseline, 3-, 6-, 9-, and 12 Months Anxiety symptoms will be assessed with the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Scores on the PHQ-9 range from 0 - 24, with higher scores indicating more severe symptoms of depression. Scores on the GAD-7 range from 0 - 21, with higher scores indicating more severe symptoms of anxiety.
Engagement in Non-Pharmacological Services/Treatments - Nonpharmacological Self-Care Approaches survey (NSCAP) Baseline, 3-, 6-, 9-, and 12 Months Engagement in nonpharmacological pain treatment will be assess with the Use of Nonpharmacological Self-Care Approaches survey (NSCAP). This survey assesses the number of times each of 9 treatments were used in the past 3 months.
Pain Intensity - Brief Pain Inventory (BPI) Baseline, 3-, 6-, 9-, and 12 Months Scores are on a range of 0 - 10, with higher scores indicating more severe pain.
Depressive Symptoms - Patient Health Questionnaire-9 (PHQ-9) Baseline, 3-, 6-, 9-, and 12 Months Depressive symptoms will be assessed with the Patient Health Questionnaire-9 (PHQ-9). Scores on the PHQ-9 range from 0 - 24, with higher scores indicating more severe symptoms of depression.
Suicidal Behavior - Electronic Health Record (EHR) Baseline, 3-, 6-, 9-, and 12 Months Data on suicidal behaviors will be extracted from the electronic health record.
Trial Locations
- Locations (4)
VA Minneapolis Health Care System
🇺🇸Minneapolis, Minnesota, United States
VA Portland Health Care System
🇺🇸Portland, Oregon, United States
VA Tennessee Valley Health Care System
🇺🇸Nashville, Tennessee, United States
VA North Texas Health Care System
🇺🇸Dallas, Texas, United States