Evaluation of a Complex Interdisciplinary Pain Assessment Program Linked to Primary Care to Improve Clinical Outcomes and Reduce Health Care Utilization Among Patients With Chronic Pain and Frequent Emergency Department Visits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 12-months post-study enrollment
研究概览
简要总结
While significant advances in pain management have occurred in the last 20 years, the majority of patients with chronic pain (CP) are unable to access evidence-based treatment at either the primary or tertiary care level.
Moreover, research has shown that unrelieved CP and the lack of available expertise contribute to emergency department (ED) visits and hospital admissions. At The Ottawa Hospital (TOH), close to 18,000 ED visits per year are related to CP (12.9%). Among high frequency visitors (HFV; >= 8 visits per year), a small number of patients with CP use an inordinate amount of acute care resources. The investigators study will use a randomized controlled (RCT) design to conduct a pilot evaluation of the impact of a Complex Interdisciplinary Pain Assessment Program (CIPAP) linked with primary care physicians (PCP) compared to a treatment as usual (TAU) control arm.
The investigators hypothesis is that implementing a CIPAP will increase health care value through improved patient outcomes and reduced costs in HFV with chronic pain (CP-HFV). The investigators believe that a CIPAP will provide CP-HFV patients long-term pain management solutions, ED visits for CP will be reduced, and hospital admissions for CP will be prevented. This pilot RCT study will inform a larger-scale RCT study to be conducted in the future.
详细描述
As this is a phase 2 trial, the sample size is primarily determined by logistical constraints; however, as this trial will yield valuable information about the preliminary impact of the program for planning a larger, more definitive trial in the future, we determined the maximum width of a two-sided 95% confidence interval around the differences between the arms at 12 months. For self-report measures, 18 patients per arm would yield a margin of error of 0.65 standard deviations (total width of confidence interval = 1.3 on the standard deviation unit scale), which is considered acceptable for the self-report measures. For number of visits over 3 months, we assumed a standard deviation of 3 (based on our preliminary data). Assuming approximate normality, our sample size of 18 patients per arm would yield a margin of error of 2 visits (total width of confidence interval = 4 visits) which is adequate to yield preliminary evidence of change. These are conservative estimates as our analyses will include repeated measures, and adjust for baseline measures of response in addition to other demographic and clinical covariates. To account for 20% attrition, we will plan to enrol 23 participants per arm (total number of participants =46).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Adult (18+ years old)
- •Working knowledge of English or French
- •Presented to The Ottawa Hospital Emergency Department (TOH ED) with a primary complaint of chronic or recurrent pain a minimum of 8 times over the last 12 months, with 3 of the visits occurring in the 3 months prior to study enrollment.
- •Patients fit criteria for chronic pain (CP) if they have had "pain that has lasted longer than three months." As per the International Association for the Study of Pain (IASP) taxonomy of CP syndromes, this includes: "relatively generalized syndromes," "relatively localized syndromes of the head and neck," "spine and radicular pain syndromes," "local syndromes of the upper limbs," and "visceral pain syndromes."
排除标准
- •Malignant pain - patients will be referred to our complex cancer pain program
- •Canadian Triage and Acuity Scale Level 1 and Level 2; Level 3 will be assessed on a case-by-case basis and we will document reason for exclusion
- •Refusal or inability to provide consent
结局指标
主要结局
Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 12-months post-study enrollment
时间窗: Baseline and 12 months post-enrollment
The primary outcome is pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale. The Brief Pain Inventory (BPI) - Pain Interference consists of 7 numerical scales (0 to 10) rating pain interference with general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life.
次要结局
- Change from baseline in self-reported anxiety, as measured by the Generalized Anxiety Disorder Scale - 7, at 12-months post-study enrollment(Baseline and 12 months post-enrollment)
- Change from baseline in self-reported sleep problems, as measured by the Insomnia Severity Index, at 12-months post-study enrollment(Baseline and 12 months post-enrollment)
- Change from baseline in self-reported traumatic stress, as measured by the PTSD Checklist for DSM - 5, at 12-months post-study enrollment(Baseline and 12 months post-enrollment)
- Change from baseline in self-reported quality of life, as measured by The Quality of Life Questionnaire EuroQol, at 12-months post-study enrollment(Baseline and 12 months post-enrollment)
- Change from 3-months pre-study enrollment in healthcare utilization, as measured by participant Ministry of Health and Long-Term Care Personal Claims History Information, at 12-months post-study enrollment(3 months pre-study and 12 months post-enrollment)
- Change from baseline in risk for opioid abuse, as measured by the Screener and Opioid Assessment for Patients with Pain, at 12-months post-study enrollment(Baseline and 12 months post-enrollment)
- Change from 3-months pre-study enrollment in opioid usage, as measured by morphine equivalents, at 12-months post-study enrollment(3 months pre-study and 12 months post-enrollment)
- Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 12-months post-study enrollment(Baseline and 12 months post-enrollment)
- Change from baseline in self-reported depressive symptoms, as measured by the Patient Health Questionnaire - 9, at 12-months post-study enrollment(Baseline and 12 months post-enrollment)
- Change from 3-months pre-study enrollment in healthcare utilization, as measured by the Pain Economics Questionnaire, at 12-months post-study enrollment(3 months pre-study and 12 months post-enrollment)