Tele-Collaborative Outreach to Rural Patients With Chronic Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: CORPs Intervention
* Behavioral: Minimally Enhanced Usual Care (MEUC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CORPs Intervention<br>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<br>* 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.<br>|
| Placebo Comparator: Minimally Enhanced Usual Care (MEUC)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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