Virtual Pain Care Management (COVID-19)

Study Overview
=================
Brief Summary
-----------------
The COVID-19 pandemic is exacerbating the challenges faced by Veterans at risk of opioid overdose including Veterans prescribed moderate-to-high dose long-term opioid therapy (LTOT) whose usual treatment resources and coping strategies may be inaccessible. This project combines established VA care components to deploy and evaluate virtual models of care for Veterans on high-risk LTOT to meet the dual challenges of maintaining social distancing and delivery high quality care.

Official Title
-----------------
Virtual Pain Care for High Risk Veterans on Opioids During COVID19 (and Beyond)

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: VCPM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants must currently receive LTOT for chronic pain at 50 mg morphine equivalent daily dose Exclusion Criteria: Exclusion criteria at baseline are: dementia diagnosis or moderate-severe cognitive impairment unstable or severe untreated psychiatric disorder or medical disease that requires hospitalization documentation of suspected controlled substance diversion inability to communicate by phone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: This single-arm feasibility study will be conducted in two VA sites.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VCPM<br>VCPM is a multi-component intervention consisting of already-established care processes and materials. First, the patient is mailed or emailed (based on their preference) an informational packet prior to intake appointment. Second, using the collaborative medication management model established in VHA,3 the intake appointment is led by the CPS using a standardized intake evaluation. The CPS and physician design a plan presented to the patient. If BUP switch is offered and accepted, the physician completes additional brief evaluations, including a history, medication review, treatment planning, and discussion of other VCPM components, using two-way audio-video visits (with telephone as a back-up). | Other: VCPM<br>* VCPM is a multi-component intervention consisting of already-established care processes and materials.<br>* Other names: Virtual Chronic Pain Management;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percent of patients who agree to Buprenorphine transfer | Although the project will use shared decision-making with Veterans, the percent of patients who agree to transfer will provide a realistic indicator of overall feasibility/acceptability. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of complete tapering or BUP transition | overall measure of engagement | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
buprenorphine