Clinical trial NCT06091202: Tele-Collaborative Outreach to Rural Patients With Chronic Pain
Official title: Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Rural
Pain
CIH
Veteran
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Portland VA Medical Center
name: Minneapolis Veterans Affairs Medical Center
name: North Texas Veterans Healthcare System
name: VA Tennessee Valley Health Care System
First posted: 2023-10-19
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Pain Interference - Brief Pain Inventory (BPI)
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
Secondary outcomes:
measure: Pain Intensity - Brief Pain Inventory (BPI)
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
measure: Physical Functioning - PROMIS Physical Functioning Scale
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
measure: Quality of Life - Veterans RAND-12 (VR-12)
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
measure: Depressive Symptoms - Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
measure: Anxiety Symptoms - Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
measure: Suicidal Behavior - Electronic Health Record (EHR)
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
measure: Quality of Sleep - PROMIS Sleep Disturbance Scale
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
measure: Engagement in Non-Pharmacological Services/Treatments - Nonpharmacological Self-Care Approaches survey (NSCAP)
timeFrame: Baseline, 3-, 6-, 9-, and 12 Months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VA Minneapolis Health Care System
state: Minnesota
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
city: Nashville
country: United States
facility: VA Tennessee Valley Health Care System
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
Study officials:
affiliation: Oregon Health & Science University, VA Portland Health Care System
name: Travis Lovejoy, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health & Science University, VA Portland Health Care System
name: Benjamin Morasco, PhD
role: PRINCIPAL_INVESTIGATOR
References: