Virtual Pain Care Management (COVID-19)

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT04539821
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-07
• Study Start: 2020-10-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-08-12
• Results First Submitted: 2022-06-08
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Results First Posted: 2024-06-14
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer	30 days	Using shared decision-making with Veterans, we will based the measure on clinical reports of patient change in opioid regimen. This would be tapering (reducing opioid dose), discontinuation, or transfer to buprenorphine. Any reduction or change was considered positive for change, even if the patients returned to their initial dose. The number of patients who agree to change their opioid regimen provides a realistic indicator of overall feasibility/acceptability.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Retained in Care at End of Study	60 days	Of participants who engaged in initial treatment the number who completed or were retained in care at the end of the study provides a outcome measure of engagement

Trial Locations

Locations (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO; 🇺🇸 Aurora, Colorado, United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States