Randomized Controlled Pilot Trial to Evaluate Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment
研究概览
简要总结
This study aims to investigate the feasibility and preliminary efficacy of an enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team, using a pilot randomized clinical trial format. Findings from this research may improve pain management and decrease risk of opioid-related adverse events among patients with chronic pain.
详细描述
The primary objective of this study is to determine whether an enhanced opioid stewardship program, tailored to the needs of patients with chronic pain, is feasible to implement in a hospital setting.
One secondary objective is to determine whether an enhanced opioid stewardship program increases use of guideline-based opioid care. The other secondary objective of this study is to determine whether an enhanced opioid stewardship program reduces pain frequency, intensity, and interference and decreases the risk for opioid-related adverse events among adult patients with chronic pain hospitalized on medical units at Yale-New Haven Hospital, York Street and Saint Raphael campuses.
This is a pilot randomized controlled trial of 100 adult participants. It is prospective and focus primarily on feasibility. There will be up to 3 study visits with each participant, which will take place during hospitalization or in the first week after hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •admitted at Yale New Haven Hospital (YSC and SRC) on medical units
- •identified as having chronic pain and prescribed opioids
- •have opioid dependence (evidenced by ongoing opioid prescription, meeting Diagnostic and Statistical Manual of Mental Disorders-5 criteria for Opioid Use Disorder, or clinical history)
排除标准
- •active cancer
- •current pregnancy
- •hospice care/comfort measures only
- •admission to inpatient psychiatry
- •completed or planned Addiction Medicine consult during hospitalization
研究组 & 干预措施
Standard of care
Enhanced Opioid Stewardship Program
Enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team
干预措施: Enhanced Opioid Stewardship Program (Other)
结局指标
主要结局
Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment
时间窗: approximately 3 months
Feasibility of recruitment will be determined by a count of the number of participants screened for the study compared to number of eligible participants.
Number of Participants in Control Group Who Complete the Peri-discharge Evaluation.
时间窗: approximately 3 months
Number of participants in the control group who were able to complete the peri-discharge evaluation to determine retention.
Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation.
时间窗: approximately 3 months
Number of participants in the intervention group who were able to complete the peri-discharge evaluation to determine retention.
Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment
时间窗: approximately 3 months
Feasibility of recruitment will be determined by a count of the number of participants eligible for the study compared to number of enrolled participants.
Days to Hospital Day of Enrollment
时间窗: approximately 3 months
Days to hospital day of enrollment in relation to admission and discharge dates
Number of Participants in the Intervention Group Who Were Able to Receive the Full Enhanced Opioid Stewardship Intervention
时间窗: approximately 3 months
Number of participants in the intervention group who were able to receive the full enhanced opioid stewardship intervention to determine retention
次要结局
- Change in Depression Measured by the Patient Health Questionnaire(Baseline and 48 hours prior to discharge from hospital)
- Patient Satisfaction Measured Using a Patient Satisfaction Survey(48 hours prior to discharge from hospital)
- Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization(up to 30 days post hospitalization)
- Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization(up to 30 days post hospitalization)
- Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.(approximately 4 months)
- Change in Pain Intensity Measured by the Brief Pain Inventory - Severity(Baseline and 48 hours prior to discharge from hospital)
- Change in Pain Intensity Measured by the Brief Pain Inventory - Interference(Baseline and 48 hours prior to discharge from hospital)