Tele-Collaborative Outreach to Rural Patients With Chronic Pain

NCT06091202 | Recruiting Phase 3 DMC

• 3 other identifiers: 253841UG3AT012257-014UH3AT012257-02
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Pain

Keywords

Rural; Pain; CIH; Veteran

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain Intensity - Brief Pain Inventory (BPI)

  Baseline, 3-, 6-, 9-, and 12 Months

• Physical Functioning - PROMIS Physical Functioning Scale

  Baseline, 3-, 6-, 9-, and 12 Months

• Quality of Life - Veterans RAND-12 (VR-12)

  Baseline, 3-, 6-, 9-, and 12 Months

• Depressive Symptoms - Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 3-, 6-, 9-, and 12 Months

• Anxiety Symptoms - Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, 3-, 6-, 9-, and 12 Months

Study Arms (2)

CORPs Intervention

ACTIVE COMPARATOR

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

Minimally Enhanced Usual Care (MEUC)

PLACEBO COMPARATOR

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)

Interventions

CORPs Intervention BEHAVIORAL

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.

Also known as: Nurse-led collaborative care

CORPs Intervention

Minimally Enhanced Usual Care (MEUC) BEHAVIORAL

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.

Also known as: One-time Education Session

Minimally Enhanced Usual Care (MEUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Portland VA Medical Center: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator
• North Texas Veterans Healthcare System: collaborator
• VA Tennessee Valley Health Care System: collaborator

Study Sites (4)

VA Minneapolis Health Care System

Minneapolis, Minnesota, 55417, United States

RECRUITING

VA Portland Health Care System

Portland, Oregon, 97239, United States

RECRUITING

VA Tennessee Valley Health Care System

Nashville, Tennessee, 37212, United States

RECRUITING

VA North Texas Health Care System

Dallas, Texas, 75216, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natassja Pal, BS

CONTACT

503-220-8262; natassja.pal@va.gov

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: July 11, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)