PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,322
- 试验地点
- 1
- 主要终点
- WP 2 - Acute pain: Sensitivity to change
研究概览
简要总结
PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. These will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain. Results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.
详细描述
In order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of PROMs which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is of consenting age (>18 years old)
- •Elective surgery
- •Planned stay in hospital for the surgery
- •First contact with the patient before surgery
- •Patient agrees to participate
排除标准
- •Patient is unable to give consent
- •Cognitive impairment
- •Questionnaire is not available in a language the patient is fluent in
- •Patient not willing to answer the follow-up questionnaire
结局指标
主要结局
WP 2 - Acute pain: Sensitivity to change
时间窗: 2019 - 2022
For WP2, the primary endpoint will be pain intensity at day 3 (NRS Scale from 0 to 10, 0 being no pain, 10 being worst pain imaginable). This primary endpoint (PROMs) will be used to assess sensitivity to change from POD3 to POD1.
WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)
时间窗: 2019 - 2022
For WP3, the primary end point will be the incidence of moderate to severe CPSP (Numeric rating scale ≥ 3/10) at 6 months using the average pain on the Brief Pain Inventory Questionnaire.
次要结局
- Objective physical activity and sleep, measured with Actigraph devices(01/2020 to 12/2021)
- Association between other POD7 PROMs and activity/sleep(01/2020 to 12/2021)
- Association between peri-operative processes and activity/sleep(01/2020 to 12/2021)
- Is decreased activity a predictor for chronic postsurgical pain?(01/2020 to 12/2021)
- Do activity trajectories since surgery parallel trajectories of other outcomes?(01/2020 to 12/2021)
- Correlation of activity difference between POD5-7 and preop with POD7 oucomes(01/2020 to 12/2021)
- Association between ambient light intensity and outcomes on POD7(01/2020 to 12/2021)
研究者
Prof. Dr. Winfried Meissner
Study coordinator
University of Jena