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Chronic Opioid UseVATPSNCT06223503

VA Transitional Pain Service Study

A study testing Transitional Pain Service in people with Chronic Opioid Use, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Opioid Use
What is being tested?
Transitional Pain Service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
1 Mar 2024to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148-0001

    Amyanne Wuthrich, MS BS, (801) 582-1565 ext. 4169, Amyanne.Wuthrich@va.gov

    Lisa A O'Hara, (801) 582-1565, lisa.o'hara@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Reducing Chronic Opioid Use Among Veterans Undergoing Community Care Surgery Using a Transitional Pain Service

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.

Read the detailed description

The Transitional Pain Service (TPS) is a novel perioperative surgical home approach that consists of comprehensive nurse care coordination before, during and for at least 6-months after surgery for Veterans at risk for chronic opioid use (COU). This program is specifically focused on 1) reducing suffering from pain and improving functional recovery after surgery; 2) preventing the development of new COU after surgery; and 3) assisting patients already on chronic opioids to taper and completely transition off narcotics during their recovery from surgery. Veterans on chronic opioids, or those identified to be at risk for persistent opioid use after surgery, are enrolled into TPS where a personalized pain management plan is developed and followed until opioid tapering is complete, or until a warm handoff can be made to their VA Primary Care Provider (PCP) to ensure continuity of care. Each Veteran's individualized pain management plan can be viewed on a SharePoint health information technology dashboard that provides clinical decision support to all VA health care providers (i.e., TPS nurse care coordinators, surgeons, VA PCPs, etc.) who provide care before and after surgery (Figure 1). Pain management and opioid use for all patients enrolled into TPS is assessed at baseline and after surgery using morphine equivalent daily dose (MEDD), and patient-reported outcomes using measures from the Patient-Reported Outcome Measurement System (PROMIS) for pain intensity (PROMIS 3a), pain interference (PROMIS 6b), and a pain catastrophizing scale (PCS) score. The TPS approach utilizes numerous evidence-based strategies that can be applied during the preoperative and postoperative period as a means to reduce opioid use and prevent CPSP among Veterans undergoing surgery at non-VA community hospitals. This includes individually tailored programs for preoperative education or pain management planning; referral for non-pharmacologic modalities such as cognitive based intervention; as well as a coordinated approach to post-discharge instructions and transitions of care. Each of these individual strategies by themselves has been shown to have an effect on improving postoperative pain management, and each is supported by current professional guidelines for the management of postoperative pain.

For Aim 1, the investigators will use claims data for opioid prescriptions submitted by non-VA surgeons across nationwide hospitals captured using the Program Integrity Tools (PIT) system for Office of Community Care data (2018-2020), and compare to pharmacy claims data for opioids prescribed to Veterans who underwent orthopedic surgery at VAMC. A risk-adjusted analysis will help determine whether non-VA surgeons are prescribing a higher quantity of opioids after surgery than VA providers. For Aim 2, the investigators will randomize Veterans from two VA medical centers who are referred for orthopedic surgery using Community Care to a transitional pain service with regular follow-up telehealth visits after surgery versus standard care. For Aim 3, the investigators will perform a qualitative study to determine what components of the telehealth TPS intervention have the greatest impact on reducing opioid use and increasing tapering after surgery at non-VA hospitals, and how often are these interventions being used as part of standard post-operative care? Semi-structured interviews will be conducted among Veterans who underwent orthopedic joint surgery at non-VA hospitals, both with and without the telehealth TPS intervention, to examined post-operative opioid usage and identify specific factors that facilitated or impeded opioid tapering.

Being tested
Transitional Pain Service
Keywords
Post-operative pain, Opioid use disorder, Opioid misuse, MISSION Act, Community Care, Transitional Care Coordination
Medical subject headings
Pain, Postoperative, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transitional Pain ServiceBehavioural

    The 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).

Study groups in NCT06223503
Study groupRoleWhat they receive
Telehealth Transitional Pain Service + Standard Postoperative Follow-Up CareExperimentalTelehealth Transitional Pain Service + Standard Postoperative Follow-Up Care
Receives: Behavioral: Transitional Pain Service
Standard Follow Up CareActive comparatorStandard Follow Up Care
Receives: Behavioral: Transitional Pain Service

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Persistent post-surgical opioid use

    The percentage of non-chronic opioid use Veterans who continue post-surgical use past 90 days after surgery.

    Measured: 90 days after surgery

Secondary outcomes (7)
  1. Quantity of opioids prescribed (MME/day)

    Number of opioid tablets prescribed at discharge and in the first 90-days after surgery.

    Measured: 90 days after surgery

  2. 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.

    Measured: 7, 30, 60, and 90-days after surgery

  3. 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.

    Measured: 7 days after surgery

  4. 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.

    Measured: 30 days after surgery

  5. Number of opioid refills after discharge from surgery

    The number of opioid prescription refills received after discharge from surgery and by 90-days after surgery.

    Measured: Between discharge from surgery and 90-days after surgery

  6. Number of opioid tablets used in the 90 days after surgery

    The difference between the number of tablets prescribed and the number of tablets left over as reported by the patient at 90 days after surgery.

    Measured: 90 days after surgery

  7. Date of last opioid use

    The date that the patient last used an opioid medication after surgery, as reported by the patient. This will be asked at days 7, 30, 60, and 90 after surgery.

    Measured: 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Veterans will be randomized to either be enrolled into the Salt Lake City VAMC transitional pain service or to receive only the usual care through the community care surgeon.
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06223503
Sponsor's protocol ID
IIR 22-062
Acronym
VATPS
Status last verified
Apr 2026
First submitted
11 Jan 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yoo M, Buys MJ, Nelson RE, Patel S, Bayless KM, Anderson Z, Hales JB, Brooke BS. Effect of Multidisciplinary Transitional Pain Service on Health Care Use and Costs Following Orthopedic Surgery. Fed Pract. 2023 Dec;40(12):418-425. doi: 10.12788/fp.0438. Epub 2023 Dec 12.

    PubMed 38812900
  • Buys MJ, Anderson Z, Bayless K, Zhang C, Presson AP, Hales J, Brooke BS. Postsurgical opioid prescribing among veterans using community care for orthopedic surgery at non-VA hospitals compared to a VA hospital with a transitional pain service: a retrospective cohort study. Reg Anesth Pain Med. 2025 Jul 4;50(7):531-537. doi: 10.1136/rapm-2023-105162.

    PubMed 38677883
  • Arnaoutakis DJ, Nguyen T, Zheng X, Mao J, Patel S, Matar AH, Brooke BS, Bismuth J, Stone DH, Scali ST. Large endograft diameter is associated with poor outcomes following thoracic endovascular aortic aneurysm repair in Medicare beneficiaries. J Vasc Surg. 2025 Dec;82(6):1947-1956.e3. doi: 10.1016/j.jvs.2025.06.030. Epub 2025 Jun 26.

    PubMed 40581193
  • Brooke BS, Bayless K, Anderson Z, Holeman TA, Zhang C, Hales J, Buys MJ. Opioid tapering after surgery and its association with patient-reported outcomes and behavioral changes: a mixed-methods analysis. Reg Anesth Pain Med. 2024 Oct 8;49(10):699-707. doi: 10.1136/rapm-2023-104807.

    PubMed 37865394

Questions about this trial

What is this clinical trial studying?

A study testing Transitional Pain Service in people with Chronic Opioid Use, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Benjamin S Brooke, MD PhD ((801) 582-1565 ext. 4169, Benjamin.Brooke@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Persistent post-surgical opioid use (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06223503, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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