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The Effect of Mobile App Home Monitoring on the Number of In-Person Visits Following Ambulatory Surgery

W

Women's College Hospital

Status

Completed

Conditions

Use of Mobile App Home Monitoring After Ambulatory Surgery

Treatments

Other: Conventional, in-person follow-up care
Device: Mobile app follow-up care

Study type

Interventional

Funder types

Other

Identifiers

NCT02318953
2013 0094 B

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Mobile app follow-up care
Experimental group
Description:
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.
Treatment:
Device: Mobile app follow-up care
Conventional, in-person follow-up care
Active Comparator group
Description:
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.
Treatment:
Other: Conventional, in-person follow-up care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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