Virtual Pain Care Management (COVID-19)

NCT04539821 | Completed Results

• 1 other identifier: C19 20-397
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain

Keywords

buprenorphine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants Retained in Care at End of Study

  60 days

Study Arms (1)

VCPM

OTHER

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

Interventions

VCPM OTHER

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

Also known as: Virtual Chronic Pain Management

VCPM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants must currently receive LTOT for chronic pain at 50 mg morphine equivalent daily dose

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Brent Moore
• Organization: VA Connecticut Healthcare System

brent.moore@va.gov

203-435-2243

Study Officials

• Brent Adams Moore, PhD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This single-arm feasibility study will be conducted in two VA sites.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 7, 2020
• Study Start: October 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: August 12, 2021
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)