The Effect of Mobile App Home Monitoring on the Number of In-Person Visits Following Ambulatory Surgery
NCT ID: NCT02318953
Last Updated: 2015-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2015-01-31
2015-08-31
Brief Summary
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Detailed Description
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Most patients receiving ambulatory breast reconstruction have a low rate of postoperative events necessitating clinic visits. However, regular follow-up is still considered important in the early post-operative phase. Increasingly, telemedicine is used to overcome the distance patients must travel to receive specialized care. Telemedicine data suggests that mobile monitoring and follow-up care is valued by patients and can reduce costs to society (1-3).
Currently, Women's College Hospital is using a mobile application (QoC Health Inc., Toronto) to complement in-person postoperative follow-up care for breast reconstruction patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Mobile app follow-up care
The mobile app follow-up group will have no planned in-person follow-up at one- and four weeks postoperative. However, these visits will be replaced with surgical site examination via submitted photos, visual analog scale (VAS) to assess pain, and the quality of recovery-9 (QoR9) questionnaire monitoring. All of this information is submitted via the mobile application (QoC Health Inc. Toronto). Patient will use daily monitoring for two weeks and then weekly monitoring for four weeks. The surgeon will use a wireless interface to access that data and monitor the patient's condition (not in real time). Physicians will summarize the clinical findings recorded by the mobile app at one week and four weeks postoperative using the prototypical "SOAP" note.
Mobile app follow-up care
The mobile app follow-up care is an application that can be loaded on to a smartphone. It allows the patient to submit photos of their surgical site, VAS pain scores, and QoR9 scores. The information collected is transmitted to members of the surgical team (i.e. the primary surgeon) and used to monitor recovery over the first 30-days following surgery.
Conventional, in-person follow-up care
Patients in the conventional, in-person follow-up group will have a planned clinic follow-up at one- and 4-weeks postoperative. This is the follow-up schedule currently used by both surgeons. At these scheduled follow-ups, patients will be asked to complete the VAS to assess pain and the QoR9 questionnaire.
Conventional, in-person follow-up care
This includes a typical in-person visit with the operating surgeon at one- and four-weeks after surgery.
Interventions
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Mobile app follow-up care
The mobile app follow-up care is an application that can be loaded on to a smartphone. It allows the patient to submit photos of their surgical site, VAS pain scores, and QoR9 scores. The information collected is transmitted to members of the surgical team (i.e. the primary surgeon) and used to monitor recovery over the first 30-days following surgery.
Conventional, in-person follow-up care
This includes a typical in-person visit with the operating surgeon at one- and four-weeks after surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Accommodation of special populations: Patients with hearing or speaking impairments will be accommodated with the help of translator. The person who regularly attends visits with her will facilitate this, or if no such person is available, we will use a hospital translator. All patients will receive an explanation of the study and the consent form in writing. All material will be understandable by patients with a grade 6 reading level. If our patients have lower than a grade 6 reading level, we will ask them if there is a family member at home who could assist them with the use of the mobile device.
18 Years
FEMALE
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Women's College Hospital
OTHER
Responsible Party
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Principal Investigators
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John Semple, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Women's College Hospital
Toronto, Ontario, Canada
Countries
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References
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Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.
Jones DT, Yoon MJ, Licameli G. Effectiveness of postoperative follow-up telephone interviews for patients who underwent adenotonsillectomy: a retrospective study. Arch Otolaryngol Head Neck Surg. 2007 Nov;133(11):1091-5. doi: 10.1001/archotol.133.11.1091.
Bailey J, Roland M, Roberts C. Is follow up by specialists routinely needed after elective surgery? A controlled trial. J Epidemiol Community Health. 1999 Feb;53(2):118-24. doi: 10.1136/jech.53.2.118.
Kazaure HS, Roman SA, Sosa JA. Association of postdischarge complications with reoperation and mortality in general surgery. Arch Surg. 2012 Nov;147(11):1000-7. doi: 10.1001/2013.jamasurg.114.
Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analyses. Panel on Cost-Effectiveness in Health and Medicine. JAMA. 1996 Oct 23-30;276(16):1339-41. doi: 10.1001/jama.276.16.1339.
Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.
Armstrong KA, Coyte PC, Brown M, Beber B, Semple JL. Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Jul 1;152(7):622-627. doi: 10.1001/jamasurg.2017.0111.
Armstrong KA, Coyte PC, Bhatia RS, Semple JL. The effect of mobile app home monitoring on number of in-person visits following ambulatory surgery: protocol for a randomized controlled trial. JMIR Res Protoc. 2015 Jun 3;4(2):e65. doi: 10.2196/resprot.4352.
Other Identifiers
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2013 0094 B
Identifier Type: -
Identifier Source: org_study_id
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