Remote Home Monitoring of Patients With a Predicted Mild Acute Pancreatitis - A Feasibility Study (REMAP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- 2. Incidence (%) of pancreatitis related complications. These complications include necrotizing pancreatitis, infection, pseudocysts, new onset diabetes, recurrence of pancreatitis, cholecystitis or cholangitis.
研究概览
简要总结
Acute pancreatitis is an inflammation of the pancreas which causes abdominal pain and is the most common gastro-intestinal reason for acute hospitalization in Western countries. Because care for a mild acute pancreatitis is supportive, early discharge of patients with a predicted mild course of acute pancreatitis might be safe with the use of remote home monitoring. This might reduce the demand for hospital beds and allow patients to benefit from recovering in their home environment. Therefore, the aim of this study is to assess the feasibility of a novel care pathway in which patients with a predicted mild course of acute pancreatitis are discharged early with remote home monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Have 2 out of 3 revised Atlanta criteria for pancreatitis:
- •Abdominal pain consistent with acute pancreatitis
- •Serum lipase ≥ 3x upper limit normal (> 159 U/l)
- •Typical pancreatic abnormalities on imaging (ultrasound, CT or MRI)
- •First episode of acute pancreatitis or a prior pancreatitis more than 3 months ago.
- •Age ≥18 years, both men and women.
- •Able and willing to provide written informed consent.
- •In possession of a working (smart)phone on which patient can be reached for the duration of participation (30 days).
排除标准
- •Chronic pancreatitis according to M-ANNHEIM criteria (20).
- •Signs of severe pancreatitis at the moment of admission to the GE ward:
- •Serum CRP > 150 mg/l
- •More than one SIRS criteria:
- •temperature < 36◦C or > 38◦C
- •heart rate > 90/min
- •respiratory rate >20/min
- •leucocytes < 4x/109l or > 12x109/l
- •MEWS (Modified Early Warning Score) ≥6 or in need of ICU admission
- •Living alone or in an institution (e.g. psychiatric ward or nursing home)
- •Known sensitivity to medical adhesives
- •Known pregnancy
- •Have one or more of the following comorbidities:
- •Heart failure (NYHA class III or IV)
- •COPD (Gold III-IV)
- •Kidney disease (>G3b) and/or kidney replacement therapy
- •Currently undergoing oncological treatment
- •Use of immunosuppressants
- •Dysregulated or poorly controlled insulin dependent diabetes
- •Morbid obesity (BMI>35 kg/m2)
- •Implantable Cardioverter Defibrillator (ICD) or Pacemaker
结局指标
主要结局
2. Incidence (%) of pancreatitis related complications. These complications include necrotizing pancreatitis, infection, pseudocysts, new onset diabetes, recurrence of pancreatitis, cholecystitis or cholangitis.
时间窗: Within 30 days of discharge
To determine the feasibility of novel care pathway
3. Mortality (%) of patients discharged home with remote monitoring.
时间窗: Within 30 days of discharge
To determine the feasibility of novel care pathway
Incidence (%) of unplanned hospital readmissions.
时间窗: Within 30 days of discharge
To determine the feasibility of novel care pathway
次要结局
- The amount of laboratory or imaging tests(Within 30 days of discharge)
- Length of stay in the hospital(Within 30 days of discharge.)
- Amount of adjustments in analgesics needed during home monitoring(Within 30 days of discharge)
- The amount of extra contacts between VMC-nurse or physician and the patient, in addition to the usual call once per day as documented in the smartphone app.(Within 30 days of discharge)