Virtual Pain Care Management (COVID-19)

NCT ID: NCT04539821

Last Updated: 2024-06-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-08-12

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This single-arm feasibility study will be conducted in two VA sites.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

VCPM

Intervention Type OTHER

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

Interventions

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VCPM

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

Intervention Type OTHER

Other Intervention Names

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Virtual Chronic Pain Management

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brent Adams Moore, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status

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

West Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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C19 20-397

Identifier Type: -

Identifier Source: org_study_id

NCT04228250

Identifier Type: -

Identifier Source: nct_alias

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