Trial Outcomes & Findings for Virtual Pain Care Management (COVID-19) (NCT NCT04539821)

Last Updated: 2024-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

30 days

Results posted on

2024-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm for this single arm all participants receive VCPM
Overall Study STARTED	44
Overall Study Engaged in CPS Care	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm for this single arm all participants receive VCPM
Overall Study Withdrawal by Subject	2
Overall Study continued care with their physician	20
Overall Study treatment needs outside scope of VCPM	3

Baseline Characteristics

Virtual Pain Care Management (COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VCPN Single Arm n=44 Participants for this single arm all participants receive VCPM
Age, Continuous	63.5 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All participants who completed the initial CPS visit

Outcome measures

Outcome measures
Measure	VCPM n=44 Participants 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.
The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer	19 Participants

SECONDARY outcome

Timeframe: 60 days

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

Outcome measures

Outcome measures
Measure	VCPM n=19 Participants 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.
Number of Participants Retained in Care at End of Study	17 participants

Adverse Events

VCPM

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VCPM n=44 participants at risk 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.
Gastrointestinal disorders Discontinuation of Buprenorphine	4.5% 2/44 • Number of events 2 • 6 months

Additional Information

Dr. Brent Moore

VA Connecticut Healthcare System

Phone: 203-435-2243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place