Back to resultsVirtual Pain Care Management (COVID-19) (VCPM)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VCPM
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Pain focused on measuring buprenorphine
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
Sites / Locations
- Rocky Mountain Regional VA Medical Center, Aurora, CO
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
VCPM
Arm Description
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).
Outcomes
Primary Outcome Measures
the percent of patients who agree to Buprenorphine transfer
Although the project will use shared decision-making with Veterans, the percent of patients who agree to transfer will provide a realistic indicator of overall feasibility/acceptability.
Secondary Outcome Measures
percent of complete tapering or BUP transition
overall measure of engagement
Full Information
NCT ID
NCT04539821
First Posted
September 3, 2020
Last Updated
August 13, 2021
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04539821
Brief Title
Virtual Pain Care Management (COVID-19)
Acronym
VCPM
Official Title
Virtual Pain Care for High Risk Veterans on Opioids During COVID19 (and Beyond)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
August 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
buprenorphine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This single-arm feasibility study will be conducted in two VA sites.
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VCPM
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
VCPM
Other Intervention Name(s)
Virtual Chronic Pain Management
Intervention Description
VCPM is a multi-component intervention consisting of already-established care processes and materials.
Primary Outcome Measure Information:
Title
the percent of patients who agree to Buprenorphine transfer
Description
Although the project will use shared decision-making with Veterans, the percent of patients who agree to transfer will provide a realistic indicator of overall feasibility/acceptability.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
percent of complete tapering or BUP transition
Description
overall measure of engagement
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Adams Moore, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Pain Care Management (COVID-19)
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