Chronic PainVCPMNCT04539821
Virtual Pain Care Management (COVID-19)
A study testing VCPM in people with Chronic Pain, run by VA Office of Research and Development at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- VCPM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2020to 12 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants must currently receive LTOT for chronic pain at 50 mg morphine equivalent daily dose
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
Official title: Virtual Pain Care for High Risk Veterans on Opioids During COVID19 (and Beyond)
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
- Being tested
- VCPM
- Keywords
- buprenorphine
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCPMOther
Also called Virtual Chronic Pain Management
VCPM is a multi-component intervention consisting of already-established care processes and materials.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: VCPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Oct 2020
- Primary completion31 May 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single-arm feasibility study will be conducted in two VA sites.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brent Adams Moore, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539821
- Sponsor's protocol ID
- C19 20-397
- Acronym
- VCPM
- Status last verified
- Jan 2024
- First submitted
- 3 Sep 2020
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Pain Care for High Risk Veterans on Opioids During COVID19 (and Beyond)
- ClinicalTrials.gov ID
- NCT04539821
- Acronym / sponsor ID
- VCPM / C19 20-397
- Conditions
- Chronic Pain
- Keywords
- buprenorphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 14 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-arm feasibility study will be conducted in two VA sites.
| Arm | Type | Receives |
|---|---|---|
| VCPM | Other | Other: VCPMVCPM 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants must currently receive LTOT for chronic pain at 50 mg morphine equivalent daily dose
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VCPMAlso: Virtual Chronic Pain ManagementVCPM is a multi-component intervention consisting of already-established care processes and materials. | Other | VCPM |
Primary outcome
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.
1 secondary outcome
Number of Participants Retained in Care at End of Study
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent Adams Moore, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VCPM in people with Chronic Pain, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.