Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000692831
Ethics application status
Approved
Date submitted
26/03/2021
Date registered
7/06/2021
Date last updated
11/05/2022
Date data sharing statement initially provided
7/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Care of Acute Diverticulitis
Scientific title
A prospective, multi-centre phase I/II trial investigating the safety and patient-reported outcomes of patients with acute uncomplicated diverticulitis through rpavirtual
Secondary ID [1] 303810 0
None
Universal Trial Number (UTN)
Trial acronym
iCAD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute diverticulitis 321314 0
Condition category
Condition code
Oral and Gastrointestinal 319103 319103 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 319595 319595 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320112 0
Treatment: Other
Intervention code [2] 320113 0
Treatment: Devices
Comparator / control treatment
The control group will be standard 'conventional' care of acute uncomplicated diverticulitis, namely, hospital admission and inpatient administration of intravenous antibiotics, bowel rest, and inpatient analgesia.
Control group
Active

Outcomes
Primary outcome [1] 326991 0
Clavien Dindo grade 3 or greater surgical complication
Timepoint [1] 326991 0
Daily for 30 days post admission to hospital or virtual healthcare
Primary outcome [2] 327453 0
Feasibility
Timepoint [2] 327453 0
Treatment retention, defined as the proportion of patients of each arm who self-decide to cross over to the other arm in the absence of any clinical indication, as well as those who cross-over for clinical indications (specifically, failure of out-of-hospital management requiring inpatient therapy), measured daily for 30 days post admission to hospital or virtual healthcare.
Secondary outcome [1] 393364 0
Hospital readmission rate, as determined by patient medical records review.
Timepoint [1] 393364 0
Daily for 30 days post discharge from hospital or virtual healthcare
Secondary outcome [2] 393367 0
Patient reported experience measures (measured using a survey which has been designed with reference to the Australian Commission on Safety and Quality in Health Care Patient Reported Experience Measure question set and the NSW Bureau of Health Information outpatient survey)
Timepoint [2] 393367 0
Measured once within 30 days after hospital discharge
Secondary outcome [3] 393368 0
Patient reported outcome measures (measured using the SF-36v2 survey)
Timepoint [3] 393368 0
Measured once within 30 days after hospital discharge

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be performed by central randomisation using REDCap software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using REDCap computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size:
This study focuses on the feasibility and safety of the iCAD model of care. No formal sample size calculation was performed for this phase I/II trial; rather, the proposed sample size is based on that which is estimated to be sufficient to obtain first data on the feasibility and safety of the intervention. For the phase I study, there will be no comparison group. 10 consecutive patients who meet inclusion criteria and provide consent to the study will be recruited to the iCAD arm. The phase II study will then help determine the logistics and feasibility of conducting a large scale phase III trial. There will be two arms to this phase II study: the intervention (iCAD pathway) and control (conventional inpatient treatment) arms. 40 consecutive patients will be 1:1 randomised to these two arms (i.e. 20 patients to each arm). A subsequent phase III randomised controlled trial is planned with further sample size calculation based on the results of this phase I/II study.

Statistical analysis:
The proportion of patients who consent to the study and the reasons for non-consent will be summarised. Following the Phase II study, characteristics of patients randomised to each group will be compared. The empirical distribution of all endpoints will be calculated, including mean, standard deviation and quartiles in case of continuous variables and scores, and with absolute and relative frequencies in case of categorical data. Two-sided 95% confidence intervals will be calculated. Endpoints between the two groups will be compared on an intention-to-treat basis, and descriptive P-values of the corresponding statistical tests comparing the two trial arms will be reported. P-values <0.05 will be considered statistically significant. Whenever appropriate, statistical graphics will be used to visualise the findings. Statistical analyses will be performed using Stata version 15 (StataCorp, College Station, Texas, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/07/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19024 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 19025 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 19026 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 33571 0
2050 - Camperdown
Recruitment postcode(s) [2] 33572 0
2139 - Concord
Recruitment postcode(s) [3] 33573 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 308208 0
Government body
Name [1] 308208 0
Sydney Local Health District
Country [1] 308208 0
Australia
Primary sponsor type
Hospital
Name
Surgical Outcomes Research Centre, Royal Prince Alfred Hospital
Address
Level 9, Royal Prince Alfred Hospital
50 Missenden Road
Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 308990 0
None
Name [1] 308990 0
Address [1] 308990 0
Country [1] 308990 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308189 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 308189 0
Level 11, KGV Building Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 308189 0
Australia
Date submitted for ethics approval [1] 308189 0
30/03/2021
Approval date [1] 308189 0
24/05/2021
Ethics approval number [1] 308189 0
2021/ETH00465

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109862 0
Dr Kheng-Seong Ng
Address 109862 0
Surgical Outcomes Research Centre
Level 9, Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW, 2050
Country 109862 0
Australia
Phone 109862 0
+61 02 9515 3200
Fax 109862 0
Email 109862 0
k.s.ng@sydney.edu.au
Contact person for public queries
Name 109863 0
Dr Kheng-Seong Ng
Address 109863 0
Surgical Outcomes Research Centre
Level 9, Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW, 2050
Country 109863 0
Australia
Phone 109863 0
+61 02 9515 3200
Fax 109863 0
Email 109863 0
k.s.ng@sydney.edu.au
Contact person for scientific queries
Name 109864 0
Dr Kheng-Seong Ng
Address 109864 0
Surgical Outcomes Research Centre
Level 9, Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW, 2050
Country 109864 0
Australia
Phone 109864 0
+61 02 9515 3200
Fax 109864 0
Email 109864 0
k.s.ng@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be made available to maintain patient privacy and confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.