Feasibility and Acceptability of a Telehealth Mindfulness Intervention to Improve Outcomes of Patients With an Acute Exacerbation of Chronic Back Pain Presenting to the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility - Retention
研究概览
简要总结
While guideline-directed nonpharmacological strategies for chronic low back pain are well established, optimal chronic pain management for emergency department patients has yet to be defined. Mindfulness interventions can be used for management of chronic conditions, yet are understudied as a primary approach for patients with chronic pain discharged from the emergency department. Currently, there is limited evidence examining whether an individual telehealth mindfulness intervention is a feasible and acceptable for these patients. This study will develop, pilot, and evaluate the feasibility and effects of an 8-session (12-week) telehealth mindfulness intervention for patients with an acute exacerbation of chronic low back pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years or older;
- •Presenting to the emergency department to address a chief complaint of an acute exacerbation of chronic low back pain;
- •Meets NIH-supported definition of chronic low back pain (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months); and
- •English-speaking due to feasibility of utilizing a telehealth mindfulness program developed in English
排除标准
- •Patients requiring hospitalization for a medical severe condition or comorbidity;
- •Patients with a severe psychiatric or behavioral diagnosis or presenting symptoms, including psychosis, delirium, active suicidal ideation, or who screen positive on the Columbia Suicide Screening;
- •Patients with a history of multiple substance use or abuse;
- •Patients involved in litigation related to the chronic pain condition; and
- •Patients who are unable to comply with the telehealth intervention (i.e., unable to provide stable home address or access telehealth link on a mobile device or computer).
结局指标
主要结局
Feasibility - Retention
时间窗: 3 months after discharge from the emergency department.
Proportion of enrolled participants who complete study.
Feasibility - Recruitment
时间窗: 3 months after discharge from emergency department
Proportion of eligible patients enrolled in study.
Feasibility - Session attendance
时间窗: 3 months after discharge from the emergency department.
Average number of sessions attended.
次要结局
- Self-reported return visits to the emergency department(3 months after discharge from the emergency department.)
- Patient Reported Outcomes Measurement Information System - Pain Interference Short Form(Baseline and 3 months after discharge from the emergency department.)
- Patient Reported Outcomes Measurement Information System - Physical Function Short Form(Baseline and 3 months after discharge from the emergency department.)
- Patient Reported Outcomes Measurement Information System - Pain Intensity(Baseline and 3 months after discharge from the emergency department.)
- Patient satisfaction with treatment(Baseline and 3 months after discharge from the emergency department.)
- Self-reported opioid medication use(Baseline and 3 months after discharge from the emergency department.)
研究者
Rogelio Coronado
Research Assistant Professor
Vanderbilt University Medical Center