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Clinical Trials/NCT04539821
NCT04539821
Completed
Not Applicable

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

VA Office of Research and Development2 sites in 1 country44 target enrollmentOctober 1, 2020
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
VA Office of Research and Development
Enrollment
44
Locations
2
Primary Endpoint
The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
August 12, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer

Time Frame: 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 Outcomes

  • Number of Participants Retained in Care at End of Study(60 days)

Study Sites (2)

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