Back to resultsTele-Collaborative Outreach to Rural Patients With Chronic Pain (CORPs)
Primary Purpose
Chronic Pain
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CORPs Intervention
Minimally Enhanced Usual Care (MEUC)
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- VA Minneapolis Health Care System
- VA Portland Health Care System
- VA Tennessee Valley Health Care System
- VA North Texas Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CORPs Intervention
Minimally Enhanced Usual Care (MEUC)
Arm Description
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.
The Minimally Enhanced Usual Care (MEUC) comparator during the pilot includes: 1) One-time consult placed to a VA pain team.
Outcomes
Primary Outcome Measures
Pain Interference
The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure.
Secondary Outcome Measures
Full Information
NCT ID
NCT06091202
First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
Oregon Health and Science University
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT06091202
Brief Title
Tele-Collaborative Outreach to Rural Patients With Chronic Pain
Acronym
CORPs
Official Title
Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CORPs Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimally Enhanced Usual Care (MEUC)
Arm Type
Placebo Comparator
Arm Description
The Minimally Enhanced Usual Care (MEUC) comparator during the pilot includes:
1) One-time consult placed to a VA pain team.
Intervention Type
Behavioral
Intervention Name(s)
CORPs Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Minimally Enhanced Usual Care (MEUC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Interference
Description
The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure.
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Travis Lovejoy, PhD, MPH
Organizational Affiliation
Oregon Health & Science University, VA Portland Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Morasco, PhD
Organizational Affiliation
Oregon Health & Science University, VA Portland Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Minneapolis Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
VA Tennessee Valley Health Care System
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tele-Collaborative Outreach to Rural Patients With Chronic Pain
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