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OpenTrials
Completed

NCT Number: NCT04539821

Virtual Pain Care Management (COVID-19)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VCPM

Other

VCPM is a multi-component intervention consisting of already-established care processes and materials.

Other names: Virtual Chronic Pain Management

Primary outcomes

  1. 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

  1. Number of Participants Retained in Care at End of Study

    Time frame: 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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: VCPM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2020
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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