An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service (TPS-Select)

University of California San Francisco (UCSF)

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Postsurgical Pain, Chronic; Opioid Use After Surgery; Postsurgical Pain Management

Treatments: Procedure: Interventional Pain Procedures; Behavioral: Physical Therapy; Behavioral: Psychological Management and Pain Education; Device: TPS-Select; Drug: Pharmacologic Pain Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07296770

24-42631

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Transitional Pain Service

Experimental group

Description:

Patients assigned to the Transitional Pain Service group will receive extra support before and after surgery to help with pain and recovery. This may include educational videos, meetings with a pain pharmacist for safe medication use and tapering, mental health screening with referrals to supportive resources, and physical therapy. Patients may also be offered pain-relief procedures or treatments such as nerve blocks, injections, imaging, or other outpatient therapies provided by pain specialists. These services are meant to support recovery, and patients may choose how much to participate while remaining in the study even if all activities are not completed.

Treatment:

Drug: Pharmacologic Pain Management

Device: TPS-Select

Behavioral: Psychological Management and Pain Education

Behavioral: Physical Therapy

Procedure: Interventional Pain Procedures

Usual Care

No Intervention group

Description:

In this arm, patients will receive usual surgical care. However, patients will still complete the questionnaires and will also have the option of a pharmacist wellness check-in at 60 days after surgery.