Colon PolypNCT04344964
Endoscopy-related Phone Consultation During the COVID-19 Outbreak
An observational study of Colon Polyp and Colon Disease, run by Austin Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Polyp, Colon Disease, Reflux, Gastroesophageal
- What is being tested?
- None - NA
- How many people
- 186 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Apr 2020to 3 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that have been submitted or were ordered any endoscopic procedure (e.g. capsule endoscopy, enteroscopy, endoscopic mucosal resection) within Austin Health - Victoria - Australia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopy-related Phone Consultation During the COVID-19 Outbreak: Impact on Attendance and Patient/Consultant Perspectives From a Tertiary Australian Hospital
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.
Read the detailed description
Telephone consultations as a method for telehealth do not provide visual cues and limit interpretation of visual signs such as visualization of skin lesions. However, the need of such feedback is almost non-existent for endoscopy-related consultations as their purpose is focused. The main foci of endoscopy-related outpatient clinics are two: 1 - inform and consent the patient for an endoscopic procedure that is to be done in the near future; 2 - explain the results of a recent procedure already performed and which has a copy provided to the patient. Therefore, phone consultations might be a good fit for endoscopy-related outpatient clinics. The practicalities and indications for the use of phone consults has been described by van Galen \& Car (2018) and fit the above description.
Patients will be invited to participate only after the consultation have been finalised and all questions regarding the endoscopic procedure to be done/that was done have been clarified. Patients and consultants will fill questionnaires to evaluate the phone consultation.
The primary outcome will the the comparison of "failed to attend" (FTA) occurrences compared to a similar period of the past year. Secondary outcomes will be patients' and consultants' satisfaction with the phone consultation.
- Being tested
- None - NA
- Medical subject headings
- Colonic Polyps, Colonic Diseases, Gastroesophageal Reflux, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - NAOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Phone consult group | Information collected prospectively on FTA patients and questionnaire (satisfaction) Receives: Other: None - NA | |
| Face-to-face consult group | Information collected retrospectively on FTA patients Receives: Other: None - NA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (2)
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start15 Apr 2020
- Primary completion29 May 2020
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Leonardo Zorron Cheng Tao Pu, Austin Health
- Investigators
- Sujievvan Chandran, MD, Principal investigator, Consultant Gastroenterologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344964
- Sponsor's protocol ID
- 38839
- Status last verified
- Jul 2020
- First submitted
- 10 Apr 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For ethical purposes as per the approval of this study as a quality improvement study (and hence exempted of formal HREC evaluation). Data should be shared outside Austin Health only through grouped data in conferences and journal papers.
Publications
Barsom EZ, Jansen M, Tanis PJ, van de Ven AWH, Blusse 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.
PubMed 32198552van Galen LS, Car J. Telephone consultations. BMJ. 2018 Mar 29;360:k1047. doi: 10.1136/bmj.k1047. No abstract available.
PubMed 29599197
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopy-related Phone Consultation During the COVID-19 Outbreak: Impact on Attendance and Patient/Consultant Perspectives From a Tertiary Australian Hospital
- ClinicalTrials.gov ID
- NCT04344964
- Acronym / sponsor ID
- 38839
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Telephone consultations as a method for telehealth do not provide visual cues and limit interpretation of visual signs such as visualization of skin lesions. However, the need of such feedback is almost non-existent for endoscopy-related consultations as their purpose is focused. The main foci of endoscopy-related outpatient clinics are two: 1 - inform and consent the patient for an endoscopic procedure that is to be done in the near future; 2 - explain the results of a recent procedure already performed and which has a copy provided to the patient. Therefore, phone consultations might be a good fit for endoscopy-related outpatient clinics. The practicalities and indications for the use of phone consults has been described by van Galen \& Car (2018) and fit the above description.
Patients will be invited to participate only after the consultation have been finalised and all questions regarding the endoscopic procedure to be done/that was done have been clarified. Patients and consultants will fill questionnaires to evaluate the phone consultation.
The primary outcome will the the comparison of "failed to attend" (FTA) occurrences compared to a similar period of the past year. Secondary outcomes will be patients' and consultants' satisfaction with the phone consultation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone consult group | – | Other: None - NAInformation collected prospectively on FTA patients and questionnaire (satisfaction) |
| Face-to-face consult group | – | Other: None - NAInformation collected retrospectively on FTA patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have been submitted or were ordered any endoscopic procedure (e.g. capsule endoscopy, enteroscopy, endoscopic mucosal resection) within Austin Health - Victoria - Australia.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - NAObservational study | Other | Face-to-face consult group, Phone consult group |
Primary outcome
Failed to attend patients
Time frame: 2 months
percentage of patients that did not answer phone calls (at least 3 calls) or with documented FTA for the retrospective group.
2 secondary outcomes
Patient satisfaction with the phone consult
Time frame: 2 months
Consultant satisfaction with the phone consult
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Background: PubMed 32198552Barsom EZ, Jansen M, Tanis PJ, van de Ven AWH, Blusse 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.
- Background: PubMed 29599197van Galen LS, Car J. Telephone consultations. BMJ. 2018 Mar 29;360:k1047. doi: 10.1136/bmj.k1047. No abstract available.
- Individual participant dataSharing planned: No. For ethical purposes as per the approval of this study as a quality improvement study (and hence exempted of formal HREC evaluation). Data should be shared outside Austin Health only through grouped data in conferences and journal papers.
Related trials for Colon Polyp
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sujievvan Chandran, MD principal investigator
Consultant Gastroenterologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Polyp and Colon Disease, run by Austin Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failed to attend patients (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344964, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.