Early Patient Identification and Care Pathway for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial of Informatics Enhanced Hospital Admission
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Use of evidence-based COPD order set
研究概览
简要总结
This is a fully automated randomized trial with two randomization branch-points. The first is inclusion of disease-specific orders in the admission orders based on a predictive model using real-time data. The second is the use of dynamic orders that are end-user tested rather than static orders designed by a committee. The primary hypothesis is that automatic inclusion of disease specific orders with admission orders will improve adherence to guidelines for patients with COPD. The secondary hypothesis is that clinical and operational outcomes will improve, thereby improving value.
详细描述
This is a single-center, single-blinded, 2x2 factorial randomized controlled trial to test both automated order set inclusion and evidence-based order set design with end user testing on order set use and clinical outcomes for adult patients admitted to the hospital with acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).
First, the investigators will develop a predictive model to identify patients admitted to the hospital with COPD exacerbations based on retrospective data, but limited to data that is available in real-time at admission.
Second, 1,000 admissions to UCSF Medical Center of adults predicted to have COPD by the predictive algorithm will be prospectively block randomized by encounter to automatic inclusion of a COPD order set in the admission orders or usual care. Providers caring for patients in both arms of the trial can independently search for and use a COPD order set. Any provider using a COPD order set in either arm will also be randomized to see two versions of the order set. The first is a static list of orders, and the second is dynamic, meaning that orders will display only when appropriate. For example, a patient who just had a chest x-ray does not need a routine repeat test. The dynamic order set will show the provider that the x-ray was completed at a specific time and will not display a prompt for a repeat test. Providers can, of course, still order anything they deem clinically appropriate, and may choose to order a repeat x-ray for a patient with a change in clinical status.
The components of the order set are based on international guidelines from the Global Initiative for Chronic Lung Disease (GOLD initiative, a collaboration between the National Heart, Lung, and Blood Institute and the World Health Organization) and a multi-stakeholder working group at UCSF including two hospitalists, two pulmonologists, two transitional care nurse specialists, one advanced practice nurse, one pharmacist, one respiratory therapist, one physical therapist, and one nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients 18 years old or greater admitted to the Hospital Medicine service at UCSF Medical Center who meet criteria as determined by predictive model to be likely admissions for COPD exacerbation.
排除标准
- •Patients admitted to other clinical services at UCSF Medical Center.
研究组 & 干预措施
Usual care and order set A
Usual care. Providers may still search for a COPD order set, and in this arm will see version A, the static list of orders, which is the current state.
Usual care and order set B
Usual care in the sense that COPD orders are not automatically included in admission orders despite likelihood of a COPD admission based on the predictive model. However, providers may still search for a COPD order set, and in this arm will see version B, the dynamic list of orders that has been end user tested prior to launch.
干预措施: Dynamic, end-user order set design (Other)
Automatic inclusion and order set A
COPD order set is automatically included in admission orders as a static list.
干预措施: Automatic inclusion of COPD orders in admission orders (Other)
Automatic inclusion and order set B
COPD order set is automatically included in admission orders as a dynamic and end user tested version.
干预措施: Automatic inclusion of COPD orders in admission orders (Other)
Automatic inclusion and order set B
COPD order set is automatically included in admission orders as a dynamic and end user tested version.
干预措施: Dynamic, end-user order set design (Other)
结局指标
主要结局
Use of evidence-based COPD order set
时间窗: one year
Proportion of admissions for COPD exacerbation that use the COPD order set
次要结局
- Average length of stay(one year)
- Number of inpatient encounters(one year)
- 30-day readmission rates(one year)
- Mortality(one year)
- Intubations(one year)
- Code blue events(one year)
- ICU admissions(one year)
- Outpatient utilization(one year)
- Proportion of enrolled patients billed for COPD related ICD-10 codes for primary or secondary diagnosis.(one year)
- Total costs of care(one year)
- Discharge Disposition(one year)
研究者
Ari Hoffman
Assistant Clinical Professor
University of California, San Francisco