NCT06223503

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Mar 2024Jul 2027

First Submitted

Initial submission to the registry

January 11, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

January 11, 2024

Last Update Submit

April 29, 2026

Conditions

Keywords

Post-operative painOpioid use disorderOpioid misuseMISSION ActCommunity CareTransitional Care Coordination

Outcome Measures

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.

    90 days after surgery

Secondary Outcomes (7)

  • Quantity of opioids prescribed (MME/day)

    90 days after surgery

  • PROMIS Assessment of Pain Intensity and Pain Interference

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

  • Assessment of Care Coordination

    7 days after surgery

  • Visit with Primary Care Provider within 30 days after surgery.

    30 days after surgery

  • Number of opioid refills after discharge from surgery

    Between discharge from surgery and 90-days after surgery

  • +2 more secondary outcomes

Study Arms (2)

Telehealth Transitional Pain Service + Standard Postoperative Follow-Up Care

EXPERIMENTAL

Telehealth Transitional Pain Service + Standard Postoperative Follow-Up Care

Behavioral: Transitional Pain Service

Standard Follow Up Care

ACTIVE COMPARATOR

Standard Follow Up Care

Behavioral: Transitional Pain Service

Interventions

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).

Standard Follow Up CareTelehealth Transitional Pain Service + Standard Postoperative Follow-Up Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Salt Lake City, Utah, 84148-0001, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 38812900BACKGROUND
  • 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.

    PMID: 38677883BACKGROUND
  • 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.

    PMID: 40581193BACKGROUND
  • 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.

    PMID: 37865394BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Benjamin S Brooke, MD PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin S Brooke, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 25, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations