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

Обзор

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.

Вмешательства

• Устройство TPS-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 dec
• Препарат Pharmacologic 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
• Процедура Interventional 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.
• Поведенческое Psychological 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 v
• Поведенческое Physical 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 parti

Первичные конечные точки

• Proportion of Patients With Chronic Post-Surgical Pain [Срок оценки: 90 days after date of surgery]

Вторичные конечные точки (3)

• Opioid Use After Surgery [Срок оценки: 30, 60, and 90 days after discharge from hospital]
• Pain Levels After Surgery [Срок оценки: 30, 60, and 90 days after discharge from the hospital]
• Healthcare Costs [Срок оценки: 30, 60, and 90 days after discharge from the hospital]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UCSF Hospitals — San Francisco

Идентификаторы

NCT: NCT07296770 · 24-42631

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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