An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT07296770
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Opioid Use After Surgery
- Postsurgical Pain Management
- Postsurgical Pain, Chronic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TPS-Select — DEVICETPS-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.
- Pharmacologic Pain Management — DRUGA 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.
- Interventional Pain Procedures — PROCEDUREIf 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.
- Psychological Management and Pain Education — BEHAVIORALPatients 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.
- Physical Therapy — BEHAVIORALPatients 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.
Study Details
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.
Key Dates
- Start date
- May 1, 2026
- Status verified
- Dec 2025
- Primary completion
- Dec 1, 2027
- Completion
- Jul 1, 2028
Study Design
- Enrollment
- 126 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Transitional Pain ServicePatients 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.
- No Intervention: Usual CareIn 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.
Primary Outcome Measure
Proportion of Patients With Chronic Post-Surgical Pain [ Time Frame: 90 days after date of surgery ]
Central Contacts
- Akash Shanmugam, BS408-242-3095
- Madeline Holt, BS978-317-9071
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Hospitals | San Francisco | California | 94131 |
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