| NCT ID | NCT06223503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Chronic Opioid Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: Aims 1 \& 3: * 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). Aim 2: * Veterans who received TPS (Aim 1) and referring VA Primary Care Providers. Exclusion Criteria: Aim 1: * 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. Aim 2: * 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. Aim 3: * The investigators will exclude Veterans who were not randomized to the TPS Telehealth intervention. * Veterans who experienced a major complication during the perioperative period or experienced an extended length of stay (LOS) based on exceeding the upper interquartile range of median LOS. * Exclusion criteria for this aim also include patients on hospice care, individuals discharged to a care facility, and those with scheduled readmissions for follow up procedure(s) within 90-days.
Contact & Investigator
Benjamin S Brooke, MD PhD
PRINCIPAL INVESTIGATOR
VA Salt Lake City Health Care System, Salt Lake City, UT
Frequently Asked Questions
Who can join the NCT06223503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Opioid Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06223503 currently recruiting?
Yes, NCT06223503 is actively recruiting participants. Contact the research team at Benjamin.Brooke@hsc.utah.edu for enrollment information.
Where is the NCT06223503 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06223503 clinical trial?
NCT06223503 is sponsored by VA Office of Research and Development. The principal investigator is Benjamin S Brooke, MD PhD at VA Salt Lake City Health Care System, Salt Lake City, UT. The trial plans to enroll 400 participants.