Clinical trial NCT05501314: Remote Home Monitoring Acute Pancreatitis
Official title: Remote Home Monitoring of Patients With a Predicted Mild Acute Pancreatitis - A Feasibility Study (REMAP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Telemedicine
Healthdot
Patient Discharge
Monitoring
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Philips Research Eindhoven
First posted: 2022-08-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: OTHER

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.


Eligibility criteria: 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 (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

Primary outcomes:
measure: Incidence (%) of unplanned hospital readmissions.
timeFrame: Within 30 days of discharge
measure: 2. Incidence (%) of pancreatitis related complications. These complications include necrotizing pancreatitis, infection, pseudocysts, new onset diabetes, recurrence of pancreatitis, cholecystitis or cholangitis.
timeFrame: Within 30 days of discharge
measure: 3. Mortality (%) of patients discharged home with remote monitoring.
timeFrame: Within 30 days of discharge
Secondary outcomes:
measure: Length of stay in the hospital
timeFrame: Within 30 days of discharge.
measure: 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.
timeFrame: Within 30 days of discharge
measure: The amount of laboratory or imaging tests
timeFrame: Within 30 days of discharge
measure: Amount of adjustments in analgesics needed during home monitoring
timeFrame: Within 30 days of discharge
Other outcomes:
measure: Patient satisfaction is assessed using a satisfaction questionnaire
timeFrame: After 14 days of discharge.
measure: Overall costs of treatment
timeFrame: Within 30 days of discharge
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital
name: C.M.J. Doggen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: