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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06091202

Collaborator

Portland VA Medical Center (U.S. Fed), National Center for Complementary and Integrative Health (NCCIH) (NIH), Minneapolis Veterans Affairs Medical Center (U.S. Fed), North Texas Veterans Healthcare System (U.S. Fed), VA Tennessee Valley Health Care System (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: CORPs Intervention Behavioral: Minimally Enhanced Usual Care (MEUC)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CORPs Intervention The CORPs Intervention is a nurse-led intervention. During the pilot the CORPs intervention includes: 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. 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.

Arm

Intervention/Treatment

Active Comparator: CORPs Intervention

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

Outcome Measures

Primary Outcome Measures

Pain Interference [1 Month]
The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Minneapolis Health Care System	Minneapolis	Minnesota	United States	55417
2	VA Portland Health Care System	Portland	Oregon	United States	97239
3	VA Tennessee Valley Health Care System	Nashville	Tennessee	United States	37212
4	VA North Texas Health Care System	Dallas	Texas	United States	75216

Sponsors and Collaborators

Oregon Health and Science University
Portland VA Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Minneapolis Veterans Affairs Medical Center
North Texas Veterans Healthcare System
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT06091202

Other Study ID Numbers:

25384
1UG3AT012257-01

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Oct 19, 2023