Developing and Pilot Testing an Intervention to Increase Opioid Tapering in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in opioid dose over six months
研究概览
简要总结
This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage patients. In a pilot randomized controlled trial (RCT), the study will examine the preliminary efficacy and feasibility of the manualized, protocol-based tapering intervention ("TapPro") compared to usual care. As there is no standard definition or outcome for tapering, the primary efficacy outcome is a decrease in OPR dose over six months. Separately, the study proposes a clinically meaningful dose reduction (greater than or equal to 30 percent) as a secondary outcome. The central hypotheses' are that a tapering intervention with patient and provider support is feasible in a primary care setting and can result in greater dose reduction when compared to usual care.
详细描述
In a 12-week randomized controlled trial based in a primary care outpatient clinic, the study will recruit 60 patients on moderate to high dose chronic opioid therapy for whom providers recommend opioid tapering and randomize 1:1 to an opioid tapering protocolized intervention (TapPro) or to usual care. Over three months, participants in the TapPro arm will visit with a clinician on the telephone on a biweekly basis in order to facilitate opioid prescribing and tapering and a pain self-care and coping curriculum. In the control arm, participants will see their primary care providers as per usual and decisions on opioid prescribing and tapering will be made by the primary care providers. Participants will be assessed throughout the study with questionnaires, urine drug screens, prescription database review, and medical record review.
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
- 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
- •chronic prescription opioid use (>3 monthly prescriptions from the clinic within prior 6 months)
- •morphine milligram equivalents (MME) ≥50
- •poorly controlled pain (PEG pain score ≥ 5/10)
- •providers considering opioid taper but no reductions in opioid dose over the past 6 months.
排除标准
- •Active cancer or other serious progressive illness, by medical review and by self-report
- •Moderate or severe opioid use disorder, as per DSM-V
- •Inability to give informed consent
- •Active suicidal ideation.
结局指标
主要结局
Change in opioid dose over six months
时间窗: Up to six months
Repeated measure analysis of opioid dosage over six months
次要结局
- Anxiety symptoms(Up to six months)
- Opioid dose reduction(Up to six months)
- Patient reported pain score(Up to six months)
- Pain interference(Up to six months)
- Pain related self-efficacy(Up to six months)
- Change in Quality of life score(Up to six months)
- Depressive symptoms(Up to six months)
- Opioid Misuse(Up to six months)
- Pain catastrophizing(Up to six months)
- Sleep quality(Up to six months)
- Opioid Knowledge(Up to six months)
研究者
Hector Perez
Principal Investigator
Albert Einstein College of Medicine