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An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service

An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07296770
Acronym
TPS-Select
Enrollment
126
Registered
2025-12-22
Start date
2026-10-01
Completion date
2028-07-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use After Surgery, Postsurgical Pain, Chronic, Postsurgical Pain Management

Keywords

Pain, Transitional Pain Service, Postsurgical Pain, Postoperative Opioid Use

Brief summary

The goal of this clinical trial is to learn whether a pain-management program called a Transitional Pain Service can help prevent long-term pain and reduce opioid needs after surgery in adult surgical patients who may be at higher risk for developing persistent pain. The main questions this trial aims to answer are: 1) Does the Transitional Pain Service help high-risk surgical patients manage pain better after surgery? 2) Can a computer tool (an algorithm) improve screening of patients for long-lasting pain after surgery? The investigators will compare patients who continue with their usual care to patients who receive support from the Transitional Pain Service to see if the program leads to better pain control and lower opioid use. Participants will share information about their pain levels and the pain-relief treatments they are using before and after surgery so researchers can better understand how the program affects recovery. Patients assigned to the Transitional Pain Service will also be offered additional coordinated support before and after their surgery to help optimize their pain control and overall recovery.

Interventions

DEVICETPS-Select

TPS-Select is a computer-based tool that helps the research team identify patients who may be eligible for this study. It uses information that already exists in the medical record at the time a surgery is scheduled to estimate the chance of developing ongoing pain after surgery. This information can include details about the planned surgery, prior medical conditions, past surgeries, and previous use of pain medications. The tool runs automatically and is used only to help the research team decide whom to contact about possible participation in the study. The risk estimate created by this tool is not added to the medical record and is not seen by the patient's care team. Only approved members of the research team can see this information through a secure research system.

DRUGPharmacologic Pain Management

A pharmacist will meet with patients as part of the Transitional Pain Service before and after surgery. During this visit, the pharmacist will work with patients to create a personalized pain management plan, using the medications stated in this intervention to help safely and effectively control pain. This will guide patients on the proper use of opioid analgesics and non-opioid analgesics, including acetaminophen, non-steroid anti-inflammatory drugs, gabapentinoids, and topical medications to manage surgical pain.

PROCEDUREInterventional Pain Procedures

If a patient has significant pain after their surgery, the care team may evaluate the patient for additional pain-relief options, such as the interventional pain procedures listed above. Local numbing medication or imaging studies may also be used to ensure the treatment is safe and appropriate. All anesthesiologists on the pain service are specially trained to perform these procedures. Only approved procedures will be offered, along with any imaging needed for evaluation.

BEHAVIORALPsychological Management and Pain Education

Patients will be asked to complete short online pain education modules to help set expectations and prepare for pain after surgery. These materials are available at https://www.transitionalpainservice.ca/learn. Each patient will also be screened for mood-related concerns, including symptoms of depression, using a brief questionnaire. If a patient has significant symptoms of depression, they may be referred to a pain psychologist and, if needed, a UCSF psychiatrist for additional support. These visits may include proven approaches such as cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based strategies to help patients manage pain, cope with stress, and improve daily functioning. Patients with milder symptoms may be referred to group-based pain psychology sessions led by a pain psychologist.

BEHAVIORALPhysical Therapy

Patients will be assessed for their physical function and ability to carry out daily activities. If a patient has difficulty with mobility, strength, or endurance, they may be referred to physical or occupational therapy before surgery to help improve overall conditioning. Pre-surgery therapy may include exercises to strengthen the core, arms, and legs, improve balance, and build stamina, as well as an overall fitness assessment. Referrals will only be made if it is safe for the patient to participate, and standard safety checks-such as heart health and fall risk-will be completed beforehand. All therapy will be provided by a licensed physical therapist using established, evidence-based treatment plans.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

After a patient joins the study, they will be randomly assigned to either the standard care group or the Transitional Pain Service (TPS) group. The assignment will be done by the study coordinator using a process that makes sure patients are evenly matched based on their level of risk. All patients in the study are considered high-risk, but the investigators will sort them into three groups-mildly severe, moderately severe, and extremely severe-to help ensure that similar patients are compared fairly across both study arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients may take part in this study if they: * Are 18 years or older * Are having a planned (elective) surgery at UCSF * Are identified as higher risk for chronic pain after surgery by a computer model * Agree to join the study and sign consent Patients cannot take part if they: * Have too much missing information in their medical record (more than 75%) * Have a surgery scheduled less than 1 month away * Have serious memory or thinking problems that make participation difficult * Are in another clinical study that would interfere with this one * Do not live in California * Choose not to participate or sign consent * Have severe depression with suicidal thoughts that requires urgent care * Are pregnant or breastfeeding A patient who has already joined may be removed from the study if they: * Cannot complete most of the scheduled follow-up phone calls or pre-surgery recommendations (up to 6 months after discharge) * Pass away between the surgery booking date and 6 months after leaving the hospital * Become pregnant in the 6 months after discharge Patients may remain enrolled but their data may not be used in the main study results if they experience: * A long-lasting infection after surgery * Hardware problems related to their surgery (for example, issues with implanted devices) * A major injury or life event that affects their pain levels, such as a significant fall or an emergency surgery * Difficulty completing the planned follow-up phone calls up to 6 months after discharge

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients With Chronic Post-Surgical Pain90 days after date of surgeryThis outcome measures how many patients in each group (Standard of Care vs. Transitional Pain Service) have chronic post-surgical pain 90 days after date of surgery. Chronic post-surgical pain refers to pain that starts after surgery and lasts longer than 3 months, gets worse after 3 months, or spreads to nearby nerves or areas connected to the surgical site. To make this diagnosis, other causes-such as infection, cancer, or pain conditions from before surgery-must be ruled out.

Secondary

MeasureTime frameDescription
Opioid Use After Surgery30, 60, and 90 days after discharge from hospitalThis measures the amount of opioid medication patients are using after surgery, recorded as morphine milligram equivalents (MMEs). Average MMEs will be compared between groups to see whether the program helps reduce opioid needs.
Pain Levels After Surgery30, 60, and 90 days after discharge from the hospitalThis outcome looks at patients' reported pain scores over time. The study will compare average pain levels between the two groups to understand how the program affects recovery.
Healthcare Costs30, 60, and 90 days after discharge from the hospitalThis measures costs to the hospital related to pain care and recovery after surgery. Average costs will be compared between groups to evaluate whether the Transitional Pain Service may reduce overall costs.

Countries

United States

Contacts

CONTACTAkash Shanmugam, BS
akash.shanmugam@ucsf.edu408-242-3095
CONTACTMadeline Holt, BS
madeline.holt@ucsf.edu978-317-9071
PRINCIPAL_INVESTIGATORAndrew Bishara, MD

UCSF Department of Anesthesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026