To assess the feasibility of a novel care program 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 study objective is to assess the feasibility of the novel care
program. Feasibility is determined by, patient satisfaction and actual use of
the novel care program, for which the following parameters will be assessed:
Patient satisfaction:
- Satisfaction with overall care (from GE-ward admittance until discontinuation
of remote home monitoring)
- Satisfaction with smartphone app
- Satisfaction with wearable sensor (Rijnstate)
- Intent to participate in the care program again
Actual use of the novel care program:
- Proportion of patients willing and able to participate
- Time between discharge decision and actual hospital discharge
- Duration of remote home monitoring
- Number of contacts between patients and healthcare professionals
- Number of additional laboratory tests
- Smartphone app functionality (generated notifications, time between
notification and contact with VMC-nurse and questionnaire compliance)
- Wearable sensor functionality (missing data and accidental detachment)
(Rijnstate)
Secondary outcome
The secondary study objective is to describe clinical outcomes of patients in
the novel care program, for which the following parameters will be assessed:
- Utilization of analgesics and anti-emetics
- Pain scores
- Food tolerance
- Activity levels
- Time between GE ward admission and discharge decision
- Hospital readmissions within 30 days of hospital admission
- Emergency department (ED) revisits within 30 days of hospital admission
- Pancreatitis-related complications within 30 days of hospital admission
- Mortality within 30 days of hospital admission
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 patients with a mild acute pancreatitis
is mostly supportive, providing this care in the home environment may be
feasible with the use of remote 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 feasibility of a novel care program in which patients with a
predicted mild course of acute pancreatitis are discharged early with remote
home monitoring.
Study design
A single center feasibility study
Intervention
After at least 48 hours of hospital admission, patients are discharged early
with the use of remote home monitoring. At home, patients receive guidance for
the management of pain, nutrition and pancreatitis-related complaints by a
daily phone call from a nurse from the Virtual Monitoring Centre (VMC). The
pancreatitis-related complaints, intake of fluids and food, pain and the use of
analgesics are assessed using short questionnaires in a smartphone app. Core
temperature is monitored using an ear thermometer and a wearable sensor
measures heart rate, respiratory rate, posture and movement every 5 minutes (in
case of inclusion at Rijnstate Hospital). Remote home monitoring will continue
for at least 4 days.
Study burden and risks
During the patient's admission to the GE ward, where usual care is provided,
patients are not exposed to additional tests or risks. However, following
hospital discharge, the patient is required to provide multiple daily updates
on their health status, which demands extra effort. Moreover, wearing the
wearable sensor may cause minor discomfort. There might be a limited additional
risk associated with the patient being at home, as they are further removed
from immediate hospital care if necessary. Nevertheless, given the natural
course of a mild acute pancreatitis and the study's stringent eligibility
criteria, no medical emergencies related to early discharge are anticipated.
Upon completion of remote home monitoring, the patient is requested to complete
a satisfaction questionnaire, which will take approximately 10 minutes of their
time. The outpatient appointment is part of usual care.
On the positive side, patients will have the opportunity to recover in their
home environment, which is believed to have potential benefits for both their
physical and mental well-being. Additionally, early discharge may contribute to
reduced healthcare costs and alleviate the demand for hospital beds. This, in
turn, enables healthcare professionals to focus their attention on patients in
greater need of hospital care.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
• Acute pancreatitis according to the revised Atlanta criteria for pancreatiti.
Which is at least 2 of the following 3 criteria:
- 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 Dutch
• In possession of a working (smart)phone on which patient can be reached for
the duration of participation (30 days)
• <=1 SIRS criteria:
* temperature < 36*C or > 38*C
* heart rate > 90/min
* respiratory rate >20/min
* leucocytes < 4x/109l or > 12x109/l
• Serum CRP <= 150 mg/l on day of discharge and with a decreasing trend in days
before
• Pain score (NRS) <=6 with or without the use of pain medication
• Adequate intake of oral food and fluids (= >=2 small meals and >=1L fluids per
day)
• Stable serum creatinine and Ringer's lactate infusion reduced to <1L/24 hours
• Independent in performing general daily life activities
Exclusion criteria
• Chronic pancreatitis according to M-ANNHEIM criteria.
• Acute cholangitis
• Endoscopic retrograde cholangiopancreatography within the first 24 hours of
admission
• MEWS (Modified Early Warning Score) >=6 or in need of ICU admission
• Living in an institution (e.g. psychiatric ward or nursing home), or the
absence of a household member capable of alerting the hospital in case of an
emergency
• 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
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT06178172 |
| CCMO | NL84869.100.23 |