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Virtual Care of Acute Diverticulitis

A prospective, multi-centre phase I/II trial investigating the safety and patient-reported outcomes of patients with acute uncomplicated diverticulitis through rpavirtual

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000692831
Acronym
iCAD Trial
Enrollment
50
Registered
2021-06-07
Start date
2022-08-18
Completion date
2024-05-11
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study investigates the feasibility and safety of managing acute uncomplicated diverticulitis using remote virtual monitoring and treatments, as opposed to standard inpatient care. Acute diverticulitis is a common condition; in 2019, almost 5,000 bed days were recorded across the Sydney Local Health District for this condition alone. There is some evidence that certain cases (primarily those with uncomplicated diverticulitis) may be managed entirely in the community with oral antibiotics, but there is apprehension amongst surgeons to use this treatment approach because of challenges in patient monitoring and early detection of clinical deterioration. One strategy to circumvent these challenges is to use virtual healthcare which allows the remote monitoring and treatment of patients, whereby current standard care may be translocated to the patient's home. This study will investigate the safety and feasibility of this approach, on the belief that such a treatment strategy may also improve patient-reported outcomes and experiences.

Interventions

Intervention: Using 'Virtual Healthcare' for the out-of-hospital management of acute uncomplicated diverticulitis Patients who meet selection criteria and who are allocated to the intervention group will be managed out-of-hospital, with their healthcare delivered by rpavirtual, a virtual hospital recently established at the Sydney Local Health District. This management includes the use of wearable technologies for remote monitoring, videoconferencing for regular patient reviews, and community-b

Intervention: Using 'Virtual Healthcare' for the out-of-hospital management of acute uncomplicated diverticulitis Patients who meet selection criteria and who are allocated to the intervention group will be managed out-of-hospital, with their healthcare delivered by rpavirtual, a virtual hospital recently established at the Sydney Local Health District. This management includes the use of wearable technologies for remote monitoring, videoconferencing for regular patient reviews, and community-based administration of intravenous antibiotics and blood tests at the patient's home. Remote monitoring will be provided 24/7 via the rpavirtual care centre, and videoconferencing of patients (approximately 15 minutes per videoconference) will be conducted by rpavirtual doctors and nurses four times per day. Intravenous antibiotics will be administered for 48 hours, after which patients will be switched to oral antibiotic therapy. Blood tests will be performed second daily. Adherence to the intervention will be monitored in real time by the rpavirtual care centre, as this intervention requires patients to participate in all their virtual reviews at pre-allocated times. The overall duration for virtual healthcare will depend on the resolution of symptoms; patients will be discharged from rpavirtual based on predefined discharge criteria. It is anticipated that most patients will receive between 3 and 7 days of virtual healthcare.

Sponsors

Surgical Outcomes Research Centre, Royal Prince Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

To be considered for this trial, patients must: 1. be diagnosed with CT-proven acute uncomplicated diverticulitis; 2. have access to a telephone, computer, or smart device with videoconferencing capabilities; 3. reside within the SLHD catchment area during the time of admission to iCAD.

Exclusion criteria

The following patient scenarios are excluded: 1. generalised peritonitis 2. temperature > 38°C 3. heart rate > 100, or evidence of haemodynamic instability 4. white cell count (WCC) >20, C reactive protein (CRP) >150, or acute renal impairment 5. other signs or symptoms concerning for systemic sepsis 6. pregnancy 7. immunosuppressed 8. cognitive impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026