The effect of mobile app home monitoring on number of in-person visits following ambulatory surgery: protocol for a randomized controlled trial

Kathleen A Armstrong, Peter C Coyte, R Sacha Bhatia, John L Semple, Kathleen A Armstrong, Peter C Coyte, R Sacha Bhatia, John L Semple

Abstract

Background: Women's College Hospital, Toronto, Canada, offers specialized ambulatory surgical procedures. Patients often travel great distances to undergo surgery. Most patients receiving ambulatory surgery have a low rate of postoperative events necessitating clinic visits. However, regular follow-up is still considered important in the early postoperative phase. Increasingly, telemedicine is used to overcome the distance patients must travel to receive specialized care. Telemedicine data suggest that mobile monitoring and follow-up care is valued by patients and can reduce costs to society. Women's College Hospital has used a mobile app (QoC Health Inc) to complement in-person postoperative follow-up care for breast reconstruction patients. Preliminary studies suggest that mobile app follow-up care is feasible, can avert in-person follow-up care, and is cost-effective from a societal and health care system perspective.

Objective: We hope to expand the use of mobile app follow-up care through its formal assessment in a randomized controlled trial. In postoperative ambulatory surgery patients at Women's College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app follow-up care compared to conventional, in-person follow-up care in the first 30 days after surgery.

Methods: This will be a pragmatic, single-center, open, controlled, 2-arm parallel-group superiority randomized trial comparing mobile app and in-person follow-up care over the first month following surgery. The patient population will comprise all postoperative ambulatory surgery patients at WCH undergoing breast reconstruction. The intervention consists of a postoperative mobile app follow-up care using the quality of recovery-9 (QoR9) and a pain visual analog scale (VAS), surgery-specific questions, and surgical site photos submitted daily for the first 2 weeks and weekly for the following 2 weeks. The primary outcome is the total number of physician visits related to the surgery over the first 30-days postoperative. The secondary outcomes include (1) the total number of phone calls and emails to a health care professional related to surgery, (2) complication rate, (3) societal and health care system costs, and (4) patient satisfaction over the first 30 days postoperative. Permutated-block randomization will be conducted by blocks of 4-6 using the program ralloc in Stata. This is an open study due to the nature of the intervention.

Results: A sample of 72 (36 patients per group) will provide an E-test for count data with a power of 95% (P=.05) to detect a difference of 1 visit between groups, assuming a 10% drop out rate. Count variables will be analyzed using Poisson regression. Categorical variables will be tested using a chi-square test. Cost-effectiveness will be analyzed using net benefit regression. Outcomes will be assessed over the first 30 days following surgery.

Conclusions: We hope to show that the use of a mobile app in follow-up care minimizes the need for in-person visits for postoperative patients.

Trial registration: Clinicaltrials.gov NCT02318953; https://ichgcp.net/clinical-trials-registry/NCT02318953 (Archived by WebCite at http://www.webcitation.org/6Yifzdjph).

Keywords: ambulatory monitoring; ambulatory surgical procedures; mobile apps; randomized controlled trial, cost-effectiveness; technology assessment.

Conflict of interest statement

Conflicts of Interest: QoC Health Inc is a private innovation group that has developed the software platform used in this study. QoC Health Inc is the sole owner of the technology. JS is part owner of QoC Health Inc. Women’s College Hospital is a demonstration partner/site for this project. The REB at Women’s College Hospital has reviewed and made recommendations pertaining to a Conflicts of Interest Management Plan.

Figures

Figure 1
Figure 1
Data collection overview diagram.

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