Virtual Pain Care Management (COVID-19)

Chronic Pain Clinical Trial

— VCPM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539821
• Other study ID #: C19 20-397
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: August 12, 2021

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT04228250

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 12, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer	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.	30 days
Secondary	Number of Participants Retained in Care at End of Study	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	60 days