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

October 13, 2023 updated by: Oregon Health and Science University

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

The overall goal of this multisite pilot trial is to pilot test and refine recruitment, intervention, and data collection protocols at four VA study sites, in preparation for a larger-scale clinical trial.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • U.S. Veteran
  • Access to landline or cell phone
  • Internet Access
  • Rural Residence based on Rural Urban Commuting Area codes
  • High Impact Chronic pain, determined through a phone screening
  • 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
  • Inability, or unwillingness, to complete informed consent via DocuSign
  • Active participation in another pain intervention study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CORPs Intervention

The CORPs Intervention is a nurse-led intervention. During the pilot the CORPs intervention includes:

  1. 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.
  2. A check-in appointment with a Nurse Care Manager around 2-weeks by phone/video to follow-up on options and goals discussed during the intake appointment.
Behavioral: CORPs Intervention

Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 1 month. The primary outcome is a change in pain interference.

After the baseline assessment, participants will complete a masked telephone assessments with research staff at 1-month follow-up, and a qualitative interview at 1-month follow-up to help inform the larger clinical trial.
Placebo Comparator: Minimally Enhanced Usual Care (MEUC)

The Minimally Enhanced Usual Care (MEUC) comparator during the pilot includes:

1) One-time consult placed to a VA pain team.
Behavioral: Minimally Enhanced Usual Care (MEUC)
Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 1 month. The primary outcome is a change in pain interference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Interference
Time Frame: 1 Month
The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure.
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

September 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)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25384
  • 1UG3AT012257-01 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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