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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage pain after surgery for Veterans at risk of opioid dependence. The goal is to determine if the Transitional Pain Service, delivered through telehealth, can help Veterans use opioids safely after orthopedic surgery. Participants will either receive this new telehealth program along with their usual care or just the standard follow-up care. Veterans planning to undergo orthopedic surgery and not currently using opioids regularly might be suitable for this trial. The trial will also collect feedback from participants to understand their experiences and satisfaction with the telehealth program. As an unphased trial, this study offers Veterans a unique opportunity to contribute to innovative pain management strategies and improve future care.

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 prior data suggests that the Transitional Pain Service is safe for Veterans undergoing orthopedic surgery?

Research has shown that the Transitional Pain Service (TPS) is generally safe and manageable for patients. In previous studies, patients using TPS after surgery significantly reduced their opioid use. For instance, one study found a 93% drop in opioid dependence among veterans new to these medications, meaning fewer veterans needed opioids long-term after surgery. Another study found that many patients required 60% fewer opioid pills.

These results suggest that TPS can manage pain effectively without causing additional harm. No major safety issues have been reported with TPS in these situations. Overall, the evidence indicates that TPS is a promising method to reduce opioid use after surgery while ensuring patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transitional Pain Service for opioid addiction because it offers a new approach to managing pain post-surgery, potentially reducing reliance on opioids. Unlike traditional methods that primarily involve in-person follow-ups, this service incorporates telehealth, making it more accessible and convenient for patients. This combination of telehealth and standard postoperative care aims to provide continuous support and guidance, which could improve pain management outcomes and reduce the risk of addiction. By integrating technology into pain management, this service has the potential to personalize care and offer timely interventions, which is a significant step forward in opioid addiction prevention.

What evidence suggests that the Telehealth Transitional Pain Service is effective for reducing chronic opioid use among Veterans?

Research has shown that the Transitional Pain Service (TPS), which participants in this trial may receive, can help reduce opioid use after surgery. In one study, TPS led to a 93% decrease in opioid dependence among veterans who underwent joint replacement surgery. Another study found a 60% drop in opioid prescriptions due to TPS. Early results from online TPS programs also suggest they help prevent new and ongoing opioid use after spine surgery. These findings highlight TPS's potential to manage pain safely and reduce opioid use in patients at risk. In this trial, some participants will receive Telehealth TPS alongside standard postoperative follow-up care, while others will receive standard follow-up care alone. ^{1 2 3 6 7}

Who Is on the Research Team?

Benjamin S Brooke, MD PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11156754/

Transitional Pain Service: An Update - PMC - PubMed Central In most of these studies, the main outcome measured was the reduction in postoperative opioid use in surgical patients. In one of the first such ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540322001838

A Multidisciplinary Transitional Pain Management Program ... In opioid-naïve veterans undergoing TJA, the TPS was associated with a 93% reduction in opioid dependence and a 60% reduction in opioid tablet prescriptions at ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03675386

Reducing Opioid Use for Chronic Pain Patients Following ... The Transitional Pain Service Program enables targeted, mechanism-based, treatment innovations aimed at reducing the incidence and severity of chronic post- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10462235/

Virtual transitional pain service delivered via telehealth is ... Virtual transitional pain service delivered via telehealth is effective in preventing new and persistent opioid use amongst post-surgical spine patients.

5. rapm.bmj.com rapm.bmj.com/content/50/2/188

Ten years of transitional pain service research and practice Preliminary results suggest that TPS treatment is associated with better opioid use outcomes, including fewer opioid tablets prescribed at discharge, better ...

6. michigan-open.org michigan-open.org/resource/transitional-pain-service-financial-tool/

Transitional Pain Service Financial Tool Approximately five to ten percent of patients undergoing surgery are considered high risk for poor pain-related and opiate-related outcomes. Patients with high ...

7. hsrd.research.va.gov hsrd.research.va.gov/research/search.cfm?ProjKeyword=Opioid%20Use

Search Results for "Opioid Use" - VA Health Systems Research Search Results for "Opioid Use" ; IIR 22-062. Reducing Chronic Opioid Use Among Veterans Undergoing Community Care Surgery Using a Transitional Pain Service.