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

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://clinicaltrials.gov/ct2/show/NCT02318953 (Archived by WebCite at http://www.webcitation.org/6Yifzdjph).

SUBMITTER: Armstrong KA

PROVIDER: S-EPMC4526905 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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

Armstrong Kathleen A KA Coyte Peter C PC Bhatia R Sacha RS Semple John L JL

JMIR research protocols 20150603 2

<h4>Background</h4>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 dat ...[more]

PMID: 26040252

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Project description:ImportanceIn the age of information and patient-centered care, new methods of delivering postoperative care must be developed and evaluated.ObjectiveTo determine whether follow-up care delivered via a mobile app can be used to avert in-person follow-up care visits compared with conventional, in-person follow-up care in the first 30 days following ambulatory surgery.Design, setting, and participantsA randomized clinical trial was conducted from February 1 to August 31, 2015, among ambulatory patients undergoing breast reconstruction at an academic ambulatory care hospital. Patients were randomly assigned to receive follow-up care via a mobile app or at an in-person visit during the first 30 days after the operation. Analysis was intention-to-treat.Main outcomes and measuresThe primary end point was the number of in-person follow-up visits during the first 30 days after the operation. Secondary end points were the number of telephone calls and emails to health care professionals, patient-reported convenience and satisfaction scores, and rates of complications.ResultsOf the 65 women in the study (mean [SD] age, 47.7 [13.4] years), 32 (49%) were in the mobile app group, and 33 (51%) were in the in-person follow-up care group. Those in the mobile app group attended a mean of 0.66 in-person visits, vs 1.64 in-person visits in the in-person follow-up care group, for a difference of 0.40 times fewer in-person visits (95% CI, 0.24-0.66; P < .001) and sent more emails to their health care professionals during the first 30 days after the operation (mean, 0.65 vs 0.15; incidence rate ratio, 4.13; 95% CI, 1.55-10.99; P = .005) than did patients in the in-person follow-up care group. This statistically significant difference was maintained at 3 months postoperatively. The mobile app group reported higher convenience scores than the in-person follow-up care group (incidence rate ratio, 1.39; 95% CI, 1.09-1.77; P = .008). There was no difference between groups in the number of telephone communications, satisfaction scores, or complication rates.Conclusions and relevancePatients undergoing ambulatory breast reconstruction can use follow-up care via a mobile app to avert in-person follow-up visits during the first 30 days after the operation. Mobile app follow-up care affects neither complication rates nor patient-reported satisfaction scores, but it improves patient-reported convenience scores.Trial registrationclinicaltrials.gov Identifier: NCT02318953.

Project description:BackgroundRisk-appropriate prenatal care has been asserted as a way for the cost-effective delivery of prenatal care. A virtual care model for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight monitoring between visits. Previous studies have demonstrated a safe reduction in the frequency of in-person prenatal care visits among low-risk patients but have noted a reduction in patient satisfaction.ObjectiveThe primary objective of this study was to test the effectiveness of a mobile prenatal care app to facilitate a reduced in-person visit schedule for low-risk pregnancies while maintaining patient and provider satisfaction.MethodsThis controlled trial compared a control group receiving usual care with an experimental group receiving usual prenatal care and using a mobile prenatal care app. The experimental group had a planned reduction in the frequency of in-person office visits, whereas the control group had the usual number of visits. The trial was conducted at 2 diverse outpatient obstetric (OB) practices that are part of a single academic center in Washington, DC, United States. Women were eligible for enrollment if they presented to care in the first trimester, were aged between 18 and 40 years, had a confirmed desired pregnancy, were not considered high-risk, and had an iOS or Android smartphone that they used regularly. We measured the effectiveness of a virtual care platform for prenatal care via the following measured outcomes: the number of in-person OB visits during pregnancy and patient satisfaction with prenatal care.ResultsA total of 88 patients were enrolled in the study, 47 in the experimental group and 41 in the control group. For patients in the experimental group, the average number of in-person OB visits during pregnancy was 7.8 and the average number in the control group was 10.2 (P=.01). There was no statistical difference in patient satisfaction (P>.05) or provider satisfaction (P>.05) in either group.ConclusionsThe use of a mobile prenatal care app was associated with reduced in-person visits, and there was no reduction in patient or provider satisfaction.Trial registrationClinicalTrials.gov NCT02914301; https://clinicaltrials.gov/ct2/show/NCT02914301 (Archived by WebCite at http://www.webcitation.org/76S55M517).

Project description:BackgroundInadequate preoperative patient preparation causes organizational, economic, and emotional problems to patients and professionals. In Spain, no current evidence is available on either the rate of compliance or the impact of good compliance with preoperative recommendations by patients in the ambulatory setting. However, it is known that around 25% of surgical cancellations in the major ambulatory surgery (MAS) are due to poor compliance with these recommendations and, therefore, avoidable. Introducing innovative tools based on mobile health (mHealth) apps may help patients meet the preoperative recommendations and, consequently, reduce the rate of cancellations in the ambulatory setting.ObjectiveThe objective of this study was to evaluate the effectiveness of the Listeo+ mHealth app as a tool for improving compliance with preoperative recommendations in MAS versus standard of care (SOC).MethodsA multicenter, randomized, open-label clinical trial that compares SOC with the additional use of Listeo+, a specific mHealth app for MAS preoperative patient monitoring, is being conducted. The study will include patients aged ≥18 years with surgical indication for MAS who meet the necessary technological and connectivity requirements. Patients in the control group will receive written preoperative recommendations, while those in the intervention group will additionally use the Listeo+ mHealth app. There will be a competitive recruitment of 790 patients during 6 months in 4 hospitals in Andalusia (Spain) that belong to the National Health System. The primary efficacy outcome is the level of compliance with preoperative recommendations. Secondary outcomes include the rate of cancellations, associated resource consumption, and perceived usability and utility with Listeo+ by participants of the intervention group. Simple randomization 1:1 procedure will be used to allocate patients to each study group.ResultsThe technological development of Listeo+ and the integration and interoperability of information systems was completed in September 2017. Subsequently, simulation tests were performed with Listeo+, and a pilot study was initiated with real patients that concluded successfully in October 2017. Patient recruitment began in December 2017 in the 4 participating centers. After an intermediate analysis performed 10 months after the start of the recruitment phase, the data collection and cleaning phases are estimated to be completed in April 2019, and the analysis with the final results will be conducted in July 2019.ConclusionsProgress in the integration and interoperability of information systems represents a major step forward in the field of mHealth. The app will allow health professionals to monitor in real-time patients' preparation and critical preoperative recommendations fulfillment. We expect a reduction in avoidable preoperative cancellations due to a lack of or a poor patient preparation. Self-assessed Web-based questionnaires and focus group will provide important information about the perceived usability and utility of Listeo+ app among patients and health care professionals.International registered report identifier (irrid)DERR1-10.2196/10938.

Project description:ImportanceThere has been an increase in health care-focused smartphone apps, including those for encouraging healthy behaviors and managing chronic conditions, but app-assisted postsurgical care has yet to be fully explored.ObjectiveTo compare quality of recovery and patient satisfaction between conventional in-person follow-up and smartphone app-assisted follow-up for patients following Enhanced Recovery After Surgery Society (ERAS) protocols.Design, setting, and participantsThis randomized clinical trial, conducted from June 2019 to April 2021, included women older than 18 years undergoing oncologic breast reconstruction or major gynecologic oncology surgery following ERAS protocols with the care of 2 surgeons at an academic tertiary care center.InterventionsPatients were randomized 1:1 to receive smartphone app-assisted follow-up or conventional in-person follow-up. The smartphone group used a surgeon-monitored app to record Quality of Recovery 15 (QoR15) scores, European Organisation for Research and Treatment of Cancer-selected adverse events, drain outputs, and surgical site photographs over 6 weeks. Patient satisfaction scores were assessed using validated Patient Satisfaction Questionnaire III (PSQ-III) subscales at 2 and 6 weeks postoperatively. The conventional follow-up group also completed the QoR15 and PSQ-III questionnaires at these intervals.Main outcomes and measuresThe primary outcomes were quality of recovery and patient satisfaction, as measured by the QoR15 and PSQ-III, respectively. Secondary outcomes were costs of follow-up; the number of contacts with the medical system, complications, and surgeons' contacts with patients; and surgeons' perceptions of app-assisted care.ResultsOf 72 patients included in the trial, 36 underwent breast reconstruction (mean [SD] age, 45.30 [9.13] years) and 36 underwent gynecologic oncology surgery (mean [SD] age, 54.90 [11.18] years). Three patients dropped out (2 who underwent breast reconstruction [1 in the app group, 1 in the control group], 1 who underwent gynecologic oncology surgery [control group]). The app group had significantly higher mean (SD) QoR15 scores than the control group (2 weeks: 127.58 [22.03] vs 117.68 [17.52], P = .02; 6 weeks: 136.64 [17.53] vs 129.76 [16.42], P = .03). Patients were equally satisfied between groups in all subsets of the PSQ-III at these intervals. The mean (SD) number of complications was similar in both groups, and a similar number of surgeon contacts per patient occurred (1.6 [1.2] vs 2.1 [2.0], P = .16). Surgeons appreciated early identification of complications with the app.Conclusions and relevanceIn this randomized clinical trial, postoperative follow-up for patients undergoing breast reconstruction and gynecologic oncology surgery using smartphone app-assisted monitoring led to improved quality of recovery and equal satisfaction with care compared with conventional in-person follow-up.Trial registrationClinicalTrials.gov Identifier: NCT03456167.

Dataset Information

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

Publications

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

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