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临床试验/NCT03082417
NCT03082417已完成不适用

Improving PAIN Control Following FRactures; Towards an Elder-friendly Emergency Department

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 1,375 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,375
试验地点
1
主要终点
Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients.

研究概览

简要总结

The PAINFREE (Improving PAIN control following FRactures; towards an Elder-friendly Emergency department) Initiative is a patient-centered multifaceted intervention which aims to improve pain management in patients 75 years and older presenting with a fracture at 7 Emergency Department of participating Montreal hospitals:

  1. Montreal General Hospital
  2. Royal Victoria Hospital
  3. Ste Mary's Hospital
  4. Hôpital de Verdun
  5. Hôpital du Sacré-Coeur de Montréal
  6. Jewish General Hospital
  7. Lakeshore General Hospital

详细描述

Using a stepped-wedge cluster randomized trial design, we will implement PAINFREE sequentially in 7 Emergency Departments (EDs) in the greater Montreal area where as each ED site acts as its own control and provides data in both pre- and post-implementation periods. Mixed methods analysis will be used to link quantitative (pain management indicators pre- and post-implementation) to qualitative (feasibility, fidelity and acceptability of implementation) data sets to facilitate data triangulation to evaluate the effects of PAINFREE in real world settings.

PAINFREE Initiative at each site includes 3 phases: pre-implementation, implementation, and post-implementation. The approach is patient-centered and is composed of three complementary components: a patient component, a physician component, and a nursing component.

Each program phases include the following steps:

  1. Pre-implementation (2 months):

  2. In all study sites, distribution and analysis of a web-based survey for nurses to document factors that can impact PAINFREE implementation in their environment

  3. Review of medical records of the target population for extraction of selected variables

  4. PAINFREE implementation (6 months):

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 75 years old or older
  • •Visiting Emergency Departments for a fracture

排除标准

  • •Having a skull fracture
  • •Having only fingers or toes fractures

研究组 & 干预措施

Pre-Implementation

No Intervention

Medical records of patients with a fracture visiting the Emergency departments will be reviewed.

Data will be collected as a baseline prior to the intervention regarding how nurses and physicians working at Emergency Departments manage acute pain in targeted population.

Implementation

Experimental

In this stepped-wedge trial design, the experimental arm refers to the time period during patients advertising and educational interventions. It consists in:

Informing patients visiting Emergency department for fracture about Pain Management Nurses and physicians working at the Emergency Departments will receive an educational interventions focused on optimal acute pain management in older adults with fracture.

干预措施: Implementation (Other)

Post-Implementation

No Intervention

Data will be collected after the intervention regarding how the intervention impacted nurses' and physicians' work in the pain management in older adults with fracture visiting Emergency Departments manage acute pain in older adults.

结局指标

主要结局

Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients.

时间窗: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)

次要结局

  • Documentation of pain score(Pre-implementation (baseline) and at 6 to 8 months (post-implementation))
  • Time to first pain score documentation(Pre-implementation (baseline) and at 6 to 8 months (post-implementation))
  • Type of analgesia used(Pre-implementation (baseline) and at 6 to 8 months (post-implementation))
  • Effectiveness of analgesia(Pre-implementation (baseline) and at 6 to 8 months (post-implementation))
  • Mean length of stay in Emergency Department(Pre-implementation (baseline) and at 6 to 8 months (post-implementation))
  • Return to the Emergency Department within 7 days after the first Visit with an uncontrolled pain due to the fracture(Pre-implementation (baseline) and at 6 to 8 months (post-implementation))
  • Evidence of worsening of Patients mental status while in Emergency Department(Pre-implementation (baseline) and at 6 to 8 months (post-implementation))

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne Morin

Associate Professor, Department of Medicine, McGill University Montreal General Hospital-McGill University Health Centre

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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