Tele-Collaborative Outreach to Rural Patients With Chronic Pain (CORPs)

Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: CORPs Intervention; Behavioral: Minimally Enhanced Usual Care (MEUC)

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 Type: Interventional
• Enrollment (Estimated): 608
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • VA Minneapolis Health Care System
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • VA Tennessee Valley Health Care System
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: CORPs Intervention; Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months. A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up.; Other Names: Nurse-led collaborative care
Placebo Comparator: 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.	Behavioral: Minimally Enhanced Usual Care (MEUC); Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months. A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up.; Other Names: One-time Education Session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference - Brief Pain Inventory (BPI)	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.	Baseline, 3-, 6-, 9-, and 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity - Brief Pain Inventory (BPI)	Scores are on a range of 0 - 10, with higher scores indicating more severe pain.	Baseline, 3-, 6-, 9-, and 12 Months
Physical Functioning - PROMIS Physical Functioning Scale	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.	Baseline, 3-, 6-, 9-, and 12 Months
Quality of Life - Veterans RAND-12 (VR-12)	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.	Baseline, 3-, 6-, 9-, and 12 Months
Depressive Symptoms - Patient Health Questionnaire-9 (PHQ-9)	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.	Baseline, 3-, 6-, 9-, and 12 Months
Anxiety Symptoms - Generalized Anxiety Disorder-7 (GAD-7)	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.	Baseline, 3-, 6-, 9-, and 12 Months
Suicidal Behavior - Electronic Health Record (EHR)	Data on suicidal behaviors will be extracted from the electronic health record.	Baseline, 3-, 6-, 9-, and 12 Months
Quality of Sleep - PROMIS Sleep Disturbance Scale	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.	Baseline, 3-, 6-, 9-, and 12 Months
Engagement in Non-Pharmacological Services/Treatments - Nonpharmacological Self-Care Approaches survey (NSCAP)	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.	Baseline, 3-, 6-, 9-, and 12 Months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Minneapolis Veterans Affairs Medical Center; National Center for Complementary and Integrative Health (NCCIH); North Texas Veterans Healthcare System; Portland VA Medical Center; VA Tennessee Valley Health Care System
• Investigators: Principal Investigator: Travis Lovejoy, PhD, MPH, Oregon Health & Science University, VA Portland Health Care System; Principal Investigator: Benjamin Morasco, PhD, Oregon Health & Science University, VA Portland Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Veteran; Rural; CIH
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain
• Other Study ID Numbers: 25384; 1UG3AT012257-01 (U.S. NIH Grant/Contract); 4UH3AT012257-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No