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NCT Number: NCT07783672

Prospective Randomized Study of TPS + CBT VS TPS Alone: Readmission, Opioid Use, and Chronic Pain

This study aims to evaluate the impact of a Transitional Pain Service (TPS) on hospital readmission rates, opioid consumption, and chronic post-surgical pain(CPSP), Despite increasing recognition of the benefits of integrated transitional pain care, there are limited prospective data evaluating its impact on 30-day readmissions, longitudinal opioid use, and CPSP. This protocol will systematically collect prospective patient data to assess these outcomes.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location contact

Lakshmi Koyyalagunta, MD

CONTACT

[email protected]

713-745-4939

Lakshmi Koyyalagunta, MD

PRINCIPAL_INVESTIGATOR

About this study

Primary Objective:

To compare the 30-day hospital readmission rate in patients seen by to the Transitional Pain Service.

Secondary Objectives:

  • To evaluate reduction in opioid use (MME) at 30, 60, 90, 180, and 365 days.
  • To evaluate patient reported outcomes using BPI, CAGE-AID, SOAPP-14, ESAS, PROMIS-29 at 30, 60, 90, 180, and 365 days to assess patient-reported quality of life and pain outcomes longitudinally.
  • To evaluate the incidence of CPSP
  • To assess demographic and clinical predictors of readmission and opioid reduction.
  • Compare outcomes between TPS patients who receive a brief, skills-based mini-CBT group intervention vs. TPS patients who do not receive mini-CBT, including:
  • Time trends across 30, 60, 90 days, and 6 and 12 months.
  • Opioid use (daily MME), and proportion achieving ≥30% MME reduction from baseline;
  • Pain intensity (NRS/10), BPI severity & interference, PROMIS-29 domains;
  • beyond 30-day hospital readmission rate

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic pain syndrome Patients with a h/o or current substance use Patients on a daily opioid dose (morphine equivalency) of ≥90 Consulted for transitional pain service

Exclusion criteria

Not seen by transitional pain service

Treatment and study plan

Transitional Pain Service

Behavioral

Participants will receive a brief, skills-based mini-CBT group intervention

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Lakshmi Koyyalagunta, MD

CONTACT

[email protected]

(713) 745-4939

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Prospective Randomized Study Of Transitional Pain Service (TPS) With Mini-Cognitive Behavioral Therapy (CBT) Versus TPS Alone For Evaluating Hospital Readmission, Opioid Outcomes, And Chronic Post-Surgical Pain

Important dates

Study start
2027
Primary completion
2029
Study completion
2031
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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