An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Chronic Post-Surgical Pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Transitional Pain Service
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.
干预措施: Physical Therapy (Behavioral)
Transitional Pain Service
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.
干预措施: TPS-Select (Device)
Transitional Pain Service
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.
干预措施: Pharmacologic Pain Management (Drug)
Transitional Pain Service
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.
干预措施: Interventional Pain Procedures (Procedure)
Transitional Pain Service
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.
干预措施: Psychological Management and Pain Education (Behavioral)
Usual Care
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.
结局指标
主要结局
Proportion of Patients With Chronic Post-Surgical Pain
时间窗: 90 days after date of surgery
This 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.
次要结局
- Opioid Use After Surgery(30, 60, and 90 days after discharge from hospital)
- Pain Levels After Surgery(30, 60, and 90 days after discharge from the hospital)
- Healthcare Costs(30, 60, and 90 days after discharge from the hospital)