REMAP: Remote Home Monitoring Acute Pancreatitis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early discharge with remote home monitoring. Patients are discharged early Patients receive remote home monitoring using a wearable sensor and a smartphone app. Patients fill in a satisfaction questionnaire |
Other: Early discharge with remote home monitoring.
After at least 48 hours of hospital admission, patients are discharged early with the use of remote home monitoring. During home monitoring, heartrate, respiratory rate, posture and movement are monitored every 5 minutes for at least 4 days, using a wearable sensor. Core temperature is monitored using an ear thermometer. Patients are contacted once per day by a nurse from the Virtual Monitoring Centre (VMC) to assess pancreatitis related complaints, intake of fluids and food, pain and the use of analgesics. Patients are asked to provide information to the hospital using a smartphone app.
|
Outcome Measures
Primary Outcome Measures
- Incidence (%) of unplanned hospital readmissions. [Within 30 days of discharge]
To determine the feasibility of novel care pathway
- 2. Incidence (%) of pancreatitis related complications. These complications include necrotizing pancreatitis, infection, pseudocysts, new onset diabetes, recurrence of pancreatitis, cholecystitis or cholangitis. [Within 30 days of discharge]
To determine the feasibility of novel care pathway
- 3. Mortality (%) of patients discharged home with remote monitoring. [Within 30 days of discharge]
To determine the feasibility of novel care pathway
Secondary Outcome Measures
- Length of stay in the hospital [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]
- The amount of laboratory or imaging tests [Within 30 days of discharge]
All bloodtests and imaging tests (US, MRI and CT-scan will be documented)
- Amount of adjustments in analgesics needed during home monitoring [Within 30 days of discharge]
Other Outcome Measures
- Patient satisfaction is assessed using a satisfaction questionnaire [After 14 days of discharge.]
Using a combination of two validated questionnaires
- Overall costs of treatment [Within 30 days of discharge]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have 2 out of 3 revised Atlanta criteria for pancreatitis:
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Abdominal pain consistent with acute pancreatitis
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Serum lipase ≥ 3x upper limit normal (> 159 U/l)
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Typical pancreatic abnormalities on imaging (ultrasound, CT or MRI)
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First episode of acute pancreatitis or a prior pancreatitis more than 3 months ago.
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Age ≥18 years, both men and women.
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Able and willing to provide written informed consent.
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In possession of a working (smart)phone on which patient can be reached for the duration of participation (30 days).
Exclusion Criteria:
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Chronic pancreatitis according to M-ANNHEIM criteria (20).
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Signs of severe pancreatitis at the moment of admission to the GE ward:
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Serum CRP > 150 mg/l
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More than one SIRS criteria:
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temperature < 36◦C or > 38◦C
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heart rate > 90/min
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respiratory rate >20/min
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leucocytes < 4x/109l or > 12x109/l
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MEWS (Modified Early Warning Score) ≥6 or in need of ICU admission
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Living alone or in an institution (e.g. psychiatric ward or nursing home)
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Known sensitivity to medical adhesives
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Known pregnancy
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Have one or more of the following comorbidities:
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Heart failure (NYHA class III or IV)
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COPD (Gold III-IV)
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Kidney disease (>G3b) and/or kidney replacement therapy
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Currently undergoing oncological treatment
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Use of immunosuppressants
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Dysregulated or poorly controlled insulin dependent diabetes
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Morbid obesity (BMI>35 kg/m2)
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Implantable Cardioverter Defibrillator (ICD) or Pacemaker
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rijnstate Hospital | Arnhem | Gelderland | Netherlands | 6815 AD |
Sponsors and Collaborators
- Rijnstate Hospital
- University of Twente
- Philips Research Eindhoven
Investigators
- Principal Investigator: C.M.J. Doggen, prof. dr., Rijnstate Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL81630.091.22