To assess the safety of a novel care pathway in which patients, with a predicted mild course of acute pancreatitis, are discharged early with remote home monitoring.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is the safety of early discharge with remote
monitoring. Safety is defined by the incidence of unplanned hospital
readmissions, the incidence of acute pancreatitis related complications and
mortality, all within 30 days of hospital admission.
Secondary outcome
The secundary parameters of the study are length of stay in the hospital,
duration of home monitoring, the amount of extra contacts between the nurse and
patient, the amount of laboratory of imaging tests, adjustments in pain
medication, patient satisfaction and overall costs.
Background 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.
Study objective
To assess the safety of a novel care pathway in which patients, with a
predicted mild course of acute pancreatitis, are discharged early with remote
home monitoring.
Study design
A safety study.
Intervention
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.
Study burden and risks
Patients are asked to wear a wearable sensor for the duration of the remote
home monitoring, which might cause minor discomfort. In addition, the patient
is asked to provide information about intake of fluids and food and possible
complaints and have phone contact with the VMC-nurse once per day. Additional
blood tests are only taken if necessary, which is expected to be less than the
usual tests once per day during hospital admission. After discontinuation of
the remote home monitoring, patients are asked to fill in a questionnaire to
assess patient satisfaction. This novel care pathway might be associated with a
small additional risk because patients are discharged early and are therefore
not in close proximity of healthcare professionals in case of an emergency.
However, early deterioration is expected to be detected by the remote
monitoring of vital signs and the daily contact with the VMC-nurse.
Furthermore, patients are able to contact the hospital 24 hours per day in case
of an emergency and are provided with direct contact information of a
healthcare professional to prevent delays.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
• 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).
Exclusion criteria
• Chronic pancreatitis according to M-ANNHEIM criteria.
• 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81630.091.22 |