Evaluating the Outcomes and Experiences of Chronic Pain Self-Management Support with an Opioid De-prescribing Intervention: a Mixed Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes in Opioid Use
研究概览
简要总结
This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach
详细描述
Chronic pain is a burden on individuals, the health system, and society. Opioid prescriptions have increased over three decades with the aim of reducing the burden of chronic pain. Unfortunately, increases in opioids have not improved functional outcomes for people with pain and opioid related side-effects and deaths have accompanied the rise in use. Opioid deprescribing (reducing the dose or transitioning off of opioids) has the potential to improve health outcomes for people on opioids for chronic pain. One of the evidence based approaches to deprescribing includes providing an interdisciplinary pain program for individuals to help manage their pain as they reduce their dose or transition off of opioids.
Unfortunately, the inability to access multidisciplinary pain programs is a barrier faced by most people living with pain and their primary care providers. Self-management support has been shown to improve pain and function for people with chronic pain and may be more feasible to offer in primary care to support people as they try to reduce their dose or transition off of opioids. Evidence on the outcomes of pairing self-management support with opioid deprescribing is lacking, however. This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach. If effective, this approach could be implemented more widely. The results of this study, therefore, have the potential to improve health outcomes for people taking opioid medications for chronic 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
- 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
- •Chronic pain for >3months
- •On opioid medications with a dose of at least 50 milligram morphine equivalents per day
- •Ability to communicate effectively using the English language, including reading and writing
排除标准
- •Chronic pain due to cancer
结局指标
主要结局
Changes in Opioid Use
时间窗: Every 2 weeks for 36 weeks
Changes in opioid use will be measured using milligram morphine equivalents per day. This will be collected every two weeks throughout the 36-week study period.
Changes in Pain Severity: Pain Severity Scale of the Brief Pain Inventory (BPI)
时间窗: Every 2 weeks for 36 weeks
Changes in pain severity will be measured using the Pain Severity Scale of the Brief Pain Inventory (BPI), which asks about the participant's pain at its worst, at its best, on overage and right now. It uses an 11-point scale ranging from 0 to 10, where 0 indicates no pain at all and 10 indicates the worst pain imaginable. The mean severity of all four individual scores will be used for the main analysis (total of all four scores divided by four). Pain severity will be assessed every two weeks, measuring the change across the course of the study.
Changes in Pain Interference: Pain Interference Scale of the Brief Pain Inventory (BPI)
时间窗: Every 2 weeks for 36 weeks
Changes in pain interference will be measured with the Pain Interference Scale of the Brief Pain Inventory (BPI), which uses an 11-point scale to measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. On the scale, 0 indicates that pain has not interfered with the activity at all and 10 indicates that pain has completely interfered with the activity. BPI Pain Interference will scored as the mean of the scores on seven interference items (total of all seven scores divided by seven). Pain interference will be assessed every two weeks, measuring the change across the course of the study.
Occurrence of Adverse Events
时间窗: Every 2 weeks for 36 weeks
Occurrence adverse events over a 36 week period will be recorded using an adverse events questionnaire that is consistent with reporting guidelines and asks: 1) if the patient has experienced any events as a result of any of the treatments received (yes/no); 2) what adverse events were experienced (choose from a drop-down list or 'other'); 3) how long the event lasted (hours or days); 4) How severe the adverse event was (0-10 scale, where 0 indicates not severe at all and 10 indicates very severe). Each occurrence (the type of adverse event and duration and severity) will be recorded individually for reporting purposes as well as descriptive purposes.
次要结局
- Adverse Childhood Experiences (ACE) Questionnaire(Baseline)
- 9-item Patient Health Questionnaire (PHQ-9)(Baseline)
- Post-traumatic Stress Disorder (PTSD) Checklist - Civilian Version(Baseline)
- Health-related Quality of Life: EuroQOL-5D (EQ-5D-5L)(Baseline)
- Global Rating of Change in function (12-weeks)(12-weeks)
- Global Rating of Change in function (36-weeks)(36 weeks)
- Goal Attainment Scale (12-weeks)(12-weeks)
- Goal Attainment Scale (36-weeks)(12-weeks and 36 weeks)
- Satisfaction with care (12-weeks): 11-point scale(12-weeks)
- Satisfaction with care (36-weeks): 11-point scale(36-weeks)
- Change in patient specific functional scale (PSFS)(Baseline, 12 weeks, 36 weeks)
研究者
Jordan Miller, PT, PhD
Assistant Professor
Queen's University