VA Transitional Pain Service Study
ConditionChronic Opioid Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
The VA Community Care Program has provided an important resource to improve access to surgical care for Veterans unable to have treatment at VA Medical Centers (VAMC). However, there is an increased risk of developing chronic opioid use when at-risk surgical patients receive opioids from non-VA providers. A multidisciplinary approach to perioperative pain management known as the Transitional Pain Service (TPS) has been shown to effectively reduce chronic opioid use among Veterans after surgery, but it is unknown whether it can be used to achieve the same outcomes for Veterans using Community Care for high-risk surgery. Through this project, the investigators will generate important data to establish whether a telehealth TPS approach can serve as a scalable and effective strategy to ensure safe opioid use among Veterans undergoing orthopedic surgery. The investigators will randomize Veterans using Community Care for orthopedic surgery to telehealth TPS versus standard of care. Finally, the investigators will interview patients using Community Care to better understand barriers and facilitators to telehealth TPS and Veteran satisfaction with the approach to pain management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The investigators will include Veterans who are referred to the Veteran Community Care Program (VCCP) for an orthopedic surgery procedure from any VA medical center throughout VISN-19.
Additionally, these Veterans must be 18+ years of age who are not on chronic opioids at the time of surgery, and who have a VA primary care provider (PCP).
Veterans who received TPS (Aim 1) and referring VA Primary Care Providers.
Disqualifiers
The investigators will exclude Veterans who are scheduled for other types of surgical procedures, are on chronic opioid therapy before surgery, are on hospice or end-of-life care, are cognitively impaired, or unable to complete the follow-up visits for any other reason.
The investigators will exclude Veterans not randomized to the TPS Telehealth intervention of Aim 1.
Primary Care Providers will be excluded if they do not primarily work at the VA.
The investigators will exclude Veterans who were not randomized to the TPS Telehealth intervention.
Trial design
Design model
Parallel
Treatments tested in this trial
Transitional Pain Service
BehavioralThe Transitional Pain Service (TPS) is a novel perioperative surgical home approach that consists of comprehensive pain management and care coordination before, during and for at least 6-months after surgery for Veterans at risk for chronic opioid use (COU).
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Telehealth Transitional Pain Service + Standard Postoperative Follow-Up CareExperimental treatment 1 intervention
Group B: Standard Follow Up CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Persistent post-surgical opioid use
The percentage of non-chronic opioid use Veterans who continue post-surgical use past 90 days after surgery.
Time frame
90 days after surgerySecondary outcomes
1
Quantity of opioids prescribed (MME/day)
Number of opioid tablets prescribed at discharge and in the first 90-days after surgery.
Time frame
90 days after surgery2
PROMIS Assessment of Pain Intensity and Pain Interference
Pain and functional patient reported outcomes using the NIH PROMIS Assessment of Pain Intensity (3a) and Pain Interference (6b). Reported as T-scores, where the average is a score of 50 and standard deviations are 10 points. A higher score represents worse pain/pain interference.
Time frame
7, 30, 60, and 90-days after surgery3
Assessment of Care Coordination
Assessment of care coordination during transitions using the Care Transitions Measure (CTM-15). All questions use a five-point Likert response scale comprising 'strongly disagree', 'disagree', 'neutral', 'agree' and 'strongly agree'. A single total score ranging from 0 to 100 is calculated from the CTM-15, with higher scores indicating better care transition.
Time frame
7 days after surgery4
Visit with Primary Care Provider within 30 days after surgery.
Determination of whether Veterans had a visit with their Primary Care Provider within 30 days after surgery. This is a yes/no outcome.
Time frame
30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov