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Virtual Pain Care Management (COVID-19) (VCPM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04539821
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: VCPM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This single-arm feasibility study will be conducted in two VA sites.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Virtual Pain Care for High Risk Veterans on Opioids During COVID19 (and Beyond)
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
VCPM
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
VCPM is a multi-component intervention consisting of already-established care processes and materials.
Other Name: Virtual Chronic Pain Management




Primary Outcome Measures :
  1. the percent of patients who agree to Buprenorphine transfer [ Time Frame: 30 days ]
    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 :
  1. percent of complete tapering or BUP transition [ Time Frame: 60 days ]
    overall measure of engagement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539821


Contacts
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Contact: Samara Zuniga, BA (203) 932-5711 Samara.Zuniga@va.gov
Contact: Brent A Moore, PhD (203) 932-5711 ext 2587 brent.moore@va.gov

Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Joseph W Frank, MD MPH    720-857-2784    joseph.frank2@va.gov   
Sub-Investigator: Joseph W Frank, MD MPH         
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Samara Zuniga, BA    (203) 932-5711    Samara.Zuniga@va.gov   
Principal Investigator: Brent Adams Moore, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Brent Adams Moore, PhD VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04539821    
Other Study ID Numbers: C19 20-397
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
buprenorphine
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations