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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04344964




Registration number
NCT04344964
Ethics application status
Date submitted
10/04/2020
Date registered
14/04/2020
Date last updated
9/07/2020

Titles & IDs
Public title
Endoscopy-related Phone Consultation During the COVID-19 Outbreak
Scientific title
Endoscopy-related Phone Consultation During the COVID-19 Outbreak: Impact on Attendance and Patient/Consultant Perspectives From a Tertiary Australian Hospital
Secondary ID [1] 0 0
38839
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon Polyp 0 0
Colon Disease 0 0
Reflux, Gastroesophageal 0 0
Varices, Esophageal 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - None - NA

Phone consult group - Information collected prospectively on FTA patients and questionnaire (satisfaction)

Face-to-face consult group - Information collected retrospectively on FTA patients


Other interventions: None - NA
Observational study

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Failed to attend patients - percentage of patients that did not answer phone calls (at least 3 calls) or with documented FTA for the retrospective group.
Timepoint [1] 0 0
2 months
Secondary outcome [1] 0 0
Patient satisfaction with the phone consult - Assessed through an online/hardcopy questionnaire based on previous studies on telehealth (adapted from Barsom et al. 2020 - MSF and PAT-VC questionnaires). These are mostly Likert-scale response mode statements.
Timepoint [1] 0 0
2 months
Secondary outcome [2] 0 0
Consultant satisfaction with the phone consult - Assessed through an online/hardcopy questionnaire based on previous studies on telehealth (adapted from Barsom et al. 2020). These are mostly Likert-scale response mode statements.
Timepoint [2] 0 0
2 months

Eligibility
Key inclusion criteria
- Patients booked for an outpatient consultation in the Post-Endoscopy clinic or
Advanced Endoscopy clinic

- Consultation determined to be held over the phone as per preventive measures due to
the COVID-19 outbreak

- Age > 18 years

- Ability to give informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Phone consultation done with a relative as per patient's preference or inability to
talk over the phone

- Patient that is deemed as confused/not able to understand

- Unwilling/unable to participate in the post-consultation survey

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to evaluate patient and consultant experiences with phone
consultations for endoscopy-related outpatient appointments during the COVID-19 outbreak.
Trial website
https://clinicaltrials.gov/show/NCT04344964
Trial related presentations / publications
Barsom EZ, Jansen M, Tanis PJ, van de Ven AWH, Blussé van Oud-Alblas M, Buskens CJ, Bemelman WA, Schijven MP. Video consultation during follow up care: effect on quality of care and patient- and provider attitude in patients with colorectal cancer. Surg Endosc. 2021 Mar;35(3):1278-1287. doi: 10.1007/s00464-020-07499-3. Epub 2020 Mar 20.
van Galen LS, Car J. Telephone consultations. BMJ. 2018 Mar 29;360:k1047. doi: 10.1136/bmj.k1047. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Sujievvan Chandran, MD
Address 0 0
Consultant Gastroenterologist
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications