Remote Home Monitoring in Mild Acute Pancreatitis (INTERACT)

Implementation of a Remote Home Monitoring Program for Patients With a Mild Acute Pancreatitis - A Single Center Feasibility Study

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. Therefore, the objective of this single center study is 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.

Patients, with a predicted mild course of acute pancreatitis. Patients with prior acute pancreatitis within 3 months or a chronic pancreatitis are excluded from participation. Patients should be ≥18 years of age. The goal is to include a total of 70 patients. 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. Remote home monitoring will continue for at least 4 days.

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. The secondary study objective is to describe clinical outcomes of patients in the novel care program.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatitis, Acute; Early Discharge; Remote Home Monitoring
• Intervention / Treatment: Other: Remote home monitoring

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Hospital
    • Contact: C.J.M. Doggen, prof.dr.; Phone Number: 0880556042; Email: cdoggen@rijnstate.nl
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Acute pancreatitis according to the revised Atlanta criteria for pancreatitis(23). 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/109/L 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(24).
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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. 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. Remote home monitoring will continue for at least 4 days.

Other: Remote home monitoring; 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. Remote home monitoring will continue for at least 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with overall care, based on satisfaction questionnaire	Overall care from GE-ward admittance until discontinuation of remote home monitoring.	Within 30 days of hospital admission
Patient satisfaction with smartphone app (Luscii), based on satisfaction questionnaire		Within 30 days of hospital admission
Patient satisfaction with wearable sensor (Healthdot), based on satisfaction questionnaire		Within 30 days of hospital admission
Patient intent to participate in the care program again	Based on satisfaction questionnaire	Within 30 days of hospital admission
Proportion of patients willing and able to participate		Within 30 days of hospital admission
Time between discharge decision and actual hospital discharge in days		Within 30 days of hospital admission
Duration of remote home monitoring in days		Within 30 days of hospital admission
Number of contacts between patients and healthcare professionals		Within 30 days of hospital admission
Number of additional laboratory tests (during home monitoring)		Within 30 days of hospital admission
Smartphone app functionality, determined by generated notifications, time between notification and contact with VMC-nurse and questionnaire compliance		Within 30 days of hospital admission
Wearable sensor functionality, determined by the amount of missing data and accidental detachments		Within 30 days of hospital admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of analgesics and anti-emetics, described as the number of days used		Within 30 days of hospital admission
Pain scores, based on NRS (0-10)		Within 30 days of hospital admission
Intake of food and fluids, described as number of meals and liters of fluid intake		Within 30 days of hospital admission
Activity levels, as measured by the wearable sensor (0-10)		Within 30 days of hospital admission
Time between GE ward admission and discharge decision in days		Within 30 days of hospital admission
Hospital readmissions		Within 30 days of hospital admission
Emergency department (ED) revisits	An ED revisit followed by a hospital readmission will be documented as a hospital readmission	Within 30 days of hospital admission
Pancreatitis-related complications	Pseudocysts, necrosis, etc.	Within 30 days of hospital admission

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: University of Twente; Philips Research Eindhoven

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2024
• Primary Completion (Estimated): June 2, 2025
• Study Completion (Estimated): October 2, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: NL84869.100.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No