Comparative Study Between Conventional and Telematic Patients Follow-up

Telemedicine Clinical Trial

— TLM-CGD  

Official title:

Comparative Study Between Conventional and Telematic Follow-up of Patient Treated in a General Ang GI Surgery Department (TLM-CGD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304509
• Other study ID #: GermansTIPH
• Status: Completed
• Phase: N/A
• Start date: March 19, 2017
• Est. completion date: August 23, 2018

Study information

• Verified date: August 2018
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 23, 2018
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• General Surgery
• Outpatients
• Telemedicine

Intervention

Other:
• Telematic follow-up
Telematic follow-up by using a platform with videoconference

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (19)

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Charles BL. Telemedicine can lower costs and improve access. Healthc Financ Manage. 2000 Apr;54(4):66-9. — View Citation

Dobke MK, Bhavsar D, Gosman A, De Neve J, De Neve B. Pilot trial of telemedicine as a decision aid for patients with chronic wounds. Telemed J E Health. 2008 Apr;14(3):245-9. doi: 10.1089/tmj.2007.0038. — View Citation

Eisenberg D, Hwa K, Wren SM. Telephone follow-up by a midlevel provider after laparoscopic inguinal hernia repair instead of face-to-face clinic visit. JSLS. 2015 Jan-Mar;19(1):e2014.00205. doi: 10.4293/JSLS.2014.00205. — View Citation

Fallaize RC, Tinline-Purvis C, Dixon AR, Pullyblank AM. Telephone follow-up following office anorectal surgery. Ann R Coll Surg Engl. 2008 Sep;90(6):464-6. doi: 10.1308/003588408X300975. Epub 2008 Jul 2. — View Citation

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Khanna V, Sambandam SN, Gul A, Mounasamy V. "WhatsApp"ening in orthopedic care: a concise report from a 300-bedded tertiary care teaching center. Eur J Orthop Surg Traumatol. 2015 Jul;25(5):821-6. doi: 10.1007/s00590-015-1600-y. Epub 2015 Jan 30. — View Citation

Kvedar J, Coye MJ, Everett W. Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth. Health Aff (Millwood). 2014 Feb;33(2):194-9. doi: 10.1377/hlthaff.2013.0992. Review. — View Citation

Pericás JM, Aibar J, Soler N, López-Soto A, Sanclemente-Ansó C, Bosch X. Should alternatives to conventional hospitalisation be promoted in an era of financial constraint? Eur J Clin Invest. 2013 Jun;43(6):602-15. doi: 10.1111/eci.12087. Epub 2013 Apr 17. Review. — View Citation

Piqueras M, Marco E, Coll M, Escalada F, Ballester A, Cinca C, Belmonte R, Muniesa JM. Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. J Rehabil Med. 2013 Apr;45(4):392-6. doi: 10.2340/16501977-1119. — View Citation

Rasmussen BS, Froekjaer J, Bjerregaard MR, Lauritsen J, Hangaard J, Henriksen CW, Halekoh U, Yderstraede KB. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care. 2015 Sep;38(9):1723-9. doi: 10.2337/dc15-0332. Epub 2015 Jun 26. — View Citation

Robaldo A, Rousas N, Pane B, Spinella G, Palombo D. Telemedicine in vascular surgery: clinical experience in a single centre. J Telemed Telecare. 2010;16(7):374-7. doi: 10.1258/jtt.2010.091011. Epub 2010 Aug 2. — View Citation

Sathiyakumar V, Apfeld JC, Obremskey WT, Thakore RV, Sethi MK. Prospective randomized controlled trial using telemedicine for follow-ups in an orthopedic trauma population: a pilot study. J Orthop Trauma. 2015 Mar;29(3):e139-45. doi: 10.1097/BOT.0000000000000189. — View Citation

Shah MN, Wasserman EB, Gillespie SM, Wood NE, Wang H, Noyes K, Nelson D, Dozier A, McConnochie KM. High-Intensity Telemedicine Decreases Emergency Department Use for Ambulatory Care Sensitive Conditions by Older Adult Senior Living Community Residents. J Am Med Dir Assoc. 2015 Dec;16(12):1077-81. doi: 10.1016/j.jamda.2015.07.009. Epub 2015 Aug 17. — View Citation

Sharareh B, Schwarzkopf R. Effectiveness of telemedical applications in postoperative follow-up after total joint arthroplasty. J Arthroplasty. 2014 May;29(5):918-922.e1. doi: 10.1016/j.arth.2013.09.019. Epub 2013 Dec 15. — View Citation

Wallace P, Haines A, Harrison R, Barber J, Thompson S, Jacklin P, Roberts J, Lewis L, Wainwright P; Virtual Outreach Project Group. Joint teleconsultations (virtual outreach) versus standard outpatient appointments for patients referred by their general practitioner for a specialist opinion: a randomised trial. Lancet. 2002 Jun 8;359(9322):1961-8. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follow-up accomplishment	Percentage of patients that can finish the follow-up in the assigned group	From date of discharge until the date of follow-up, 30 days after discharge
Secondary	Emergency department consultation	Comparison between number of emergency department consultations in each group if related to the surgical procedure	From discharge until 30 days after the follow-up date
Secondary	Patient satisfaction	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.	30 days after the follow-up date