Comparative Study Between Conventional and Telematic Patients Follow-up

Not Applicable

Completed

• Conditions: Telemedicine; General Surgery; Outpatients
• Interventions: Other: Telematic follow-up

• Registration Number: NCT03304509
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief Summary

This is a parallel group clinical trial comparing two types of follow-up in patients operated and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by using a platform that offers videoconferencing will be compared.

Patients will be included and assigned randomly to each group using an informatics program until 100 patients are reached in each arm of the study ("n" total = 200 patients) The main and secondary outcomes will be evaluated 30 days after the date of the follow-up.

Detailed Description

This is a parallel group clinical trial comparing two types of follow-up in patients operated and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by using a platform that offers videoconferencing will be compared.

The hypothesis is that a follow-up based on a telematic visit will no add extra comorbidities while could reduce costs and increase patients satisfaction.

Patients will be included and assigned randomly to each group using an informatics program until 100 patients are reached in each arm of the study ("n" total = 200 patients) Information regarding the type of follow-up and the instructions to perform the telematic visit will be provided to patients before discharge. The follow-up date will be set according to the established protocol for each type of pathology.

In case of clinical complications patients will be referred to the emergency department or will be visited in face-to-face basis.

The main and secondary outcomes will be evaluated 30 days after the date of the follow-up.

Study Timeline

• Study Start: 2017-03-19
• Study First Submitted: 2017-09-30
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-09
• Primary Completion: 2018-05-10
• Status Verified: 2018-08
• Study Completion: 2018-08-23
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients treated or operated in the General and GI Surgery department in "Hospital Germans Trias i Pujol"

Exclusion Criteria

• Proctological Surgery
• Personal conditions that not allow a correct comprehension or developement of the study
• Patients with postoperative complications greater than Clavien-Dindo grade II
• Not being in possession of the necessary informatic devices in case of telematic follow-up
• Not having a basic informatic knowledge in case of telematic follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telematic follow-up	Telematic follow-up	Telematic follow-up after hospital discharge

Primary Outcome Measures

Name	Time	Method
Follow-up accomplishment	From date of discharge until the date of follow-up, 30 days after discharge	Percentage of patients that can finish the follow-up in the assigned group

Secondary Outcome Measures

Name	Time	Method
Emergency department consultation	From discharge until 30 days after the follow-up date	Comparison between number of emergency department consultations in each group if related to the surgical procedure
Patient satisfaction	30 days after the follow-up date	Assessment of the patient satisfaction related to the follow-up using the NHS Outpatients Questionnaire. The results will be the comparision of percentage of each answer in each group.

Trial Locations

Locations (1)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain