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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04344964
Other study ID # 38839
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date July 3, 2020

Study information

Verified date July 2020
Source Austin Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date July 3, 2020
Est. primary completion date May 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
None - NA
Observational study

Locations

Country Name City State
Australia Austin Health Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Austin Health

Country where clinical trial is conducted

Australia, 

References & Publications (2)

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. 2020 Mar 20. doi: 10.1007/s00464-020-07499-3. [Epub ahead of print] — View Citation

van Galen LS, Car J. Telephone consultations. BMJ. 2018 Mar 29;360:k1047. doi: 10.1136/bmj.k1047. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 months
Secondary 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. 2 months
Secondary 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. 2 months
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