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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCPM | Other | VCPM is a multi-component intervention consisting of already-established care processes and materials. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria at baseline are:
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| Name | Affiliation | Role |
|---|---|---|
| Brent Adams Moore, PhD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045 | United States | ||
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | for this single arm all participants receive VCPM |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | VCPN Single Arm | for this single arm all participants receive VCPM |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who completed the initial CPS visit | Posted | Count of Participants | Participants | 30 days |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). VCPM: VCPM is a multi-component intervention consisting of already-established care processes and materials. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discontinuation of Buprenorphine | Gastrointestinal disorders | Non-systematic Assessment | expected side effects of Buprenorphine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brent Moore | VA Connecticut Healthcare System | 203-435-2243 | brent.moore@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2020 | Jan 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This single-arm feasibility study will be conducted in two VA sites.
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| West Haven |
| Connecticut |
| 06516 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Posted | Number | participants | 60 days |
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| 1 |
| 44 |
| 0 |
| 44 |
| 2 |
| 44 |
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