Clinical trial NCT02318953: The Effect of Mobile App Home Monitoring on the Number of In-Person Visits Following Ambulatory Surgery
Official title: The Effect of Mobile App Home Monitoring on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Use of Mobile App Home Monitoring After Ambulatory Surgery
Keywords: Telemedicine
Ambulatory Surgical Procedures
Postoperative Care
Cost Effectiveness
Mobile Applications
Health Services Research
Breast Reconstruction
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-12-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluate if in an ambulatory breast reconstruction patient population at Women's College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app home monitoring compared to conventional, in-person follow-up care in the first 30-days following surgery.

Detailed description: Women's College Hospital offers specialized surgical procedures, including breast reconstruction. Patients often travel great distances to undergo surgery. The average ambulatory breast reconstruction patient travels 76 km from home to hospital, with the furthest patient coming from 540 km away.

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing breast reconstruction at Women's College Hospital. They must be able to use a mobile device and communicate in English.

Exclusion Criteria:

* They must be non-smokers because smokers carry increased rates of complication and both surgeons have a policy to solely operate on non-smokers (minimum smoke-free period of one month leading to surgery). Pain ratings captured in the VAS and QoR9 are important for judging quality of postoperative recovery. Pre-existing pain or an inability to take narcotics would compromise the reliability of these measures. Therefore, patients must not suffer from chronic pain. They must not be taking narcotic (morphine-like) medication for pain on a regular basis. They must not have an allergy to local anesthetics or morphine-like medications.

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.

Primary outcomes:
measure: The total number of physician visits related to the surgery
timeFrame: 30 days
Secondary outcomes:
measure: The total number of health care telephone calls and emails related to the surgery.
timeFrame: 30 days
measure: Number of complications
timeFrame: 30 days
measure: Societal and healthcare system costs
timeFrame: 30 days
measure: Patient satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: John Semple, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.