Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary opioid outcome: percent of patients at or below their pre-trauma opioid daily dose
研究概览
简要总结
The investigators will enroll 100 participants using a randomized control trial design to implement and evaluate an individualized opioid taper program supporting rural Primary Care Physicians (PCPs) caring for patients with moderate to severe trauma discharged on opioids. This study will link a trauma center Physician Assistant (PA) with rural PCPs to facilitate pain care and the individualized opioid taper. The investigators seek to improve patient's pain and opioid outcomes and support the PCPs who assume care for these complex patients after hospital discharge.
Our long term goal is to provide a service that will help trauma patients as they go back into primary care and into pain- and opioid-free living.
详细描述
This study explores the feasibility, efficacy, and potential sustainability of a collaborative pain care/opioid taper strategy for patients discharged to a rural PCP practice on opioids after hospitalization for moderate to severe traumatic injury.
The randomized control study design will provide important pilot data on the efficacy of opioid taper in the context of engaged pain management care at the PCP level when the PCP is supported by expert consultation and has broad implications for patient and clinician education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The team member that coordinates subject's follow-up survey completion after hospital discharge will be masked.
Team members involved with outcome analysis will be masked.
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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
- •Must be at least 18 years old
- •Injury Severity Score of 9 or greater
- •Resident of Washington state
- •Will be discharged to a rural zip code outside of king county.
- •Glasgow Coma Score of 15
- •Able to read, speak, and write English or Spanish.
- •Has an identifiable PCP or willing to accept referral to a local Federally Qualified Health Center (FQHC)
- •Has an insurer included in the All Payer Claims Database
- •Planned to be discharged on opioid medication
- •Planned to be discharged back to the community
排除标准
- •Less than 18 years old
- •Injury Severity Score less than 9
- •Patient is in judicial custody
- •Resident of a state other than Washington
- •Will not be discharged to a rural zip code outside of king county.
- •Evidence of OUD diagnosis (including using heroin or other illicit opioids in the past month, a DSM-5 OUD diagnosis, or evidence of taking methadone, buprenorphine, or naltrexone).
- •Currently in cancer treatment or enrolled in palliative or hospice care
- •Residing in a nursing home or assisted living facility
- •Using any implanted device for pain control
- •Self-report of heroin or other illicit opioid use in the past month
- •Psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year (including current admission).
结局指标
主要结局
Primary opioid outcome: percent of patients at or below their pre-trauma opioid daily dose
时间窗: 24 weeks
Percent of patients at or below pre-trauma opioid dose
Primary pain outcome: Pain, Enjoyment, General Activity (PEG)
时间窗: 24 weeks
Patient reported 0-10 pain severity, enjoyment of life interference, general activity interference total score
次要结局
- PROMIS-29 health status(24 weeks)
- Past-month cannabis use(24 weeks)
- satisfaction with pain care(24 weeks)
- Illicit drug use(24 weeks)
- Problem alcohol use(24 weeks)
研究者
Mark Sullivan
Professor, School of Medicine
University of Washington