Transitional Pain Service for Opioid Addiction

(VATPS Trial)

Overseen By Michael J Buys, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Chronic opioids

Disqualifiers: Cognitive impairment, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does mention that participants should not be on chronic opioid therapy before surgery.

What data supports the effectiveness of the treatment Transitional Pain Service for opioid addiction?

Research shows that a Transitional Pain Service (TPS), which includes a team of healthcare professionals working together, can help reduce long-term opioid use and improve recovery after surgery. This approach has been effective in managing pain and reducing opioid dependence in patients undergoing various types of surgeries, including joint and trauma surgeries. ^{1 2 3 4 5}

Is the Transitional Pain Service safe for humans?

The Transitional Pain Service (TPS) has been used in various surgical settings to manage pain and reduce opioid use, with no specific safety concerns reported in the studies. It involves a team approach to pain management, which includes personalized care and support for reducing opioid dependence. ^{1 2 3 4 6}

How is the Transitional Pain Service treatment different from other treatments for opioid addiction?

The Transitional Pain Service (TPS) is unique because it offers a multidisciplinary approach that combines personalized pain management, opioid tapering plans, and psychological support, such as acceptance and commitment therapy (ACT). This integrated care model aims to reduce opioid use and improve recovery outcomes, which is different from standard treatments that may not address these aspects comprehensively. ^{1 2 3 4 5}

Research Team

Benjamin S Brooke, MD PhD

Principal Investigator

VA Salt Lake City Health Care System, Salt Lake City, UT

Eligibility Criteria

This trial is for Veterans who are at risk of chronic opioid use after orthopedic surgery. They must be using the VA Community Care Program and not receiving treatment directly from a VA Medical Center. Specific inclusion or exclusion criteria aren't provided, but typically participants would need to meet certain health standards.

Inclusion Criteria

Aim 2: Veterans who received TPS (Aim 1) and referring VA Primary Care Providers

Exclusion Criteria

I am a veteran not in the TPS Telehealth, had no major surgery issues, and wasn't discharged to a facility.

I am a veteran not on chronic opioids, not in hospice, cognitively sound, and can attend follow-ups.

Aim 2: Veterans not randomized to the TPS Telehealth intervention of Aim 1, Primary Care Providers who do not primarily work at the VA

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Care

Preoperative education and pain management planning, including referral for non-pharmacologic modalities

2 weeks

Surgery and Immediate Postoperative Care

Veterans undergo orthopedic surgery and receive immediate postoperative care

1 week

Telehealth Transitional Pain Service

Regular follow-up telehealth visits for pain management and opioid tapering

6 months

Regular telehealth visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of opioid use and pain management

3 months

Treatment Details

Interventions

• Transitional Pain Service

Trial Overview The study tests if a telehealth Transitional Pain Service (TPS) can help Veterans manage pain and reduce chronic opioid use after surgery, compared to standard care. Participants will be randomly assigned to either the TPS group or receive usual post-surgery care.

Participant Groups

Group I: Telehealth Transitional Pain Service + Standard Postoperative Follow-Up Care Experimental Treatment 1 Intervention

Telehealth Transitional Pain Service + Standard Postoperative Follow-Up Care

Group II: Standard Follow Up Care Active Control 1 Intervention

Standard Follow Up Care

Transitional Pain Service is already approved in United States for the following indications:

Approved in United States as Transitional Pain Service for:

• Perioperative pain management
• Prevention of chronic opioid use

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The implementation of a transitional pain service (TPS) significantly reduced the proportion of patients taking opioids 90 days after orthopedic surgeries, with only 13.4% of TPS patients using opioids compared to 27.3% before TPS implementation.

Patients in the TPS group had 69% lower odds of developing chronic opioid use after surgery, and those with prior opioid use were more likely to reduce or stop their opioid consumption post-surgery, indicating the TPS's effectiveness in managing pain and minimizing opioid dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid use among veterans undergoing major joint surgery managed by a multidisciplinary transitional pain service. Buys, MJ., Bayless, K., Romesser, J., et al.[2021]

The transitional pain service (TPS) did not significantly improve the quality of recovery on the third postoperative day compared to standard care, as measured by the QoR-15 questionnaire in a study of 176 patients.

However, TPS showed a notable reduction in opioid consumption among chronic opioid users over six months, suggesting potential long-term benefits in managing pain and improving daily functioning, although the study's small sample size limits the strength of these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a transitional pain service in patients undergoing surgery with an increased risk of developing chronic postsurgical pain (TRUSt study). A randomized clinical trial. Admiraal, M., Hermanides, J., Meinsma, SL., et al.[2023]

Patients receiving long-term coordinated multimodal pain care through a transitional pain service (TPS) after trauma surgery experienced significant reductions in opioid use, pain severity, and improved overall functioning over an average treatment duration of 2.8 years.

The inclusion of psychiatric care in the TPS helped address mental health issues that arose after trauma, suggesting that a multidisciplinary approach can enhance recovery and reduce the risk of long-term opioid dependence and disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidisciplinary transitional pain service to improve pain outcomes following trauma surgery: a preliminary report. Flynn, HK., Manoharan, D., Hsu, YJ., et al.[2023]

The Transitional Pain Service (TPS) program was successfully implemented for spine surgery patients, enrolling 83.3% of eligible participants and effectively tracking outcomes for over 80% of them.

Patients in the TPS program significantly reduced their opioid consumption, with all participants either maintaining or lowering their oral morphine equivalent intake, and reported improved perceptions of pain management and overall health after the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a multidisciplinary Transitional Pain Service in spine surgery patients to minimise opioid use and improve perioperative outcomes: a quality improvement study. Tierney, S., Magnan, MC., Zahrai, A., et al.[2023]

A 59-year-old male with a history of chronic pain and escalating opioid use experienced significant pain reduction and improved quality of life after receiving integrated care from a transitional pain service following emergency surgery for a bleeding duodenal ulcer.

The multidisciplinary approach included the use of buprenorphine combined with naloxone and acceptance and commitment therapy (ACT), demonstrating an effective strategy for managing complex postsurgical pain while addressing opioid dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case report on the treatment of complex chronic pain and opioid dependence by a multidisciplinary transitional pain service using the ACT Matrix and buprenorphine/naloxone. Weinrib, AZ., Burns, LC., Mu, A., et al.[2022]

The Transitional Pain Service (TPS) significantly reduced persistent opioid use in patients after total joint arthroplasty, with only 0.7% of patients using opioids at 90 days post-discharge compared to 9.9% in the control group.

The TPS also led to a 60% reduction in the number of opioid tablets prescribed, with median consumption of 20.5 tablets for total hip arthroplasty (THA) and 36.5 for total knee arthroplasty (TKA), indicating a successful shift towards nonopioid pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Transitional Pain Management Program Is Associated With Reduced Opioid Dependence After Primary Total Joint Arthroplasty. Featherall, J., Anderson, JT., Anderson, LA., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Opioid use among veterans undergoing major joint surgery managed by a multidisciplinary transitional pain service. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of a transitional pain service in patients undergoing surgery with an increased risk of developing chronic postsurgical pain (TRUSt study). A randomized clinical trial. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

A multidisciplinary transitional pain service to improve pain outcomes following trauma surgery: a preliminary report. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of a multidisciplinary Transitional Pain Service in spine surgery patients to minimise opioid use and improve perioperative outcomes: a quality improvement study. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A case report on the treatment of complex chronic pain and opioid dependence by a multidisciplinary transitional pain service using the ACT Matrix and buprenorphine/naloxone. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Transitional Pain Management Program Is Associated With Reduced Opioid Dependence After Primary Total Joint Arthroplasty. [2022]