Tele-Collaborative Outreach to Rural Patients With Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Pain

• 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.

Study Timeline

• Study Start: 2023-10-02
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-02
• Primary Completion: 2027-05-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 608

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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