Tele-Collaborative Outreach to Rural Patients With Chronic Pain

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

Interventions

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.

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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Portland VA Medical Center

  collaborator FED

• Minneapolis Veterans Affairs Medical Center

  collaborator FED

• North Texas Veterans Healthcare System

  collaborator FED

• VA Tennessee Valley Health Care System

  collaborator FED

• Oregon Health and Science University

  lead OTHER

Principal Investigators

• Travis Lovejoy, PhD, MPH · Oregon Health & Science University, VA Portland Health Care System

• Benjamin Morasco, PhD · Oregon Health & Science University, VA Portland Health Care System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-11

Primary Completion

2027-05-01

Completion

2027-06-01

Countries

• United States

Study Locations