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Endoscopy-related Phone Consultation During the COVID-19 Outbreak

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04344964
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : July 9, 2020
Information provided by (Responsible Party):
Leonardo Zorron Cheng Tao Pu, Austin Health

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.

Condition or disease Intervention/treatment
Colon Polyp Colon Disease Reflux, Gastroesophageal Varices, Esophageal Other: None - NA

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.

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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Endoscopy-related Phone Consultation During the COVID-19 Outbreak: Impact on Attendance and Patient/Consultant Perspectives From a Tertiary Australian Hospital
Actual Study Start Date : April 15, 2020
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : July 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
Phone consult group
Information collected prospectively on FTA patients and questionnaire (satisfaction)
Other: None - NA
Observational study

Face-to-face consult group
Information collected retrospectively on FTA patients
Other: None - NA
Observational study

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Patient satisfaction with the phone consult [ Time Frame: 2 months ]
    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.

  2. Consultant satisfaction with the phone consult [ Time Frame: 2 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04344964

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Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
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Principal Investigator: Sujievvan Chandran, MD Consultant Gastroenterologist
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Responsible Party: Leonardo Zorron Cheng Tao Pu, Endoscopy Fellow, Austin Health Identifier: NCT04344964    
Other Study ID Numbers: 38839
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Diseases
Gastroesophageal Reflux
Esophageal and Gastric Varices
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Hypertension, Portal
Liver Diseases