Use of Mobile App Home Monitoring After Ambulatory SurgeryNCT02318953
The Effect of Mobile App Home Monitoring on the Number of In-Person Visits Following Ambulatory Surgery
A study testing Mobile app follow-up care and Conventional, in-person follow-up care in people with Use of Mobile App Home Monitoring After Ambulatory Surgery, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Use of Mobile App Home Monitoring After Ambulatory Surgery
- What is being tested?
- Mobile app follow-up care and Conventional, in-person follow-up care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Aug 2015
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing breast reconstruction at Women's College Hospital. They must be able to use a mobile device and communicate in English.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile App Home Monitoring on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Control Trial
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.
Read the 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.
- Being tested
- Mobile app follow-up care, Conventional, in-person follow-up care
- Keywords
- Telemedicine, Ambulatory Surgical Procedures, Postoperative Care, Cost Effectiveness, Mobile Applications, Health Services Research, Breast Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app follow-up careDevice
Also called QoC Health Inc. mobile application
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 careOther
This includes a typical in-person visit with the operating surgeon at one- and four-weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Mobile app follow-up care | Experimental | 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. Receives: Device: Mobile app follow-up care |
| Conventional, in-person follow-up care | Active comparator | 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. Receives: Other: Conventional, in-person follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of physician visits related to the surgery
The total number of physician visits will include visits to the specialist, family physician, and emergency department related to surgery. This data will be captured by patient survey at two- and four-weeks after surgery.
Measured: 30 days
Secondary outcomes (4)
The total number of health care telephone calls and emails related to the surgery.
The total number of health care telephone calls and emails will include specialist, family physician, and emergency services. This data will be captured by patient survey at two- and four-weeks after surgery.
Measured: 30 days
Number of complications
We will record and report all complications occurring within the 30-day period. This was chosen based on literature surrounding postoperative complications in the first 30-days (4). This will be captured by patient survey at two- and four-weeks after surgery.
Measured: 30 days
Societal and healthcare system costs
A societal perspective will be adopted wherein all cost are assessed irrespective of the payer. This perspective was chosen based on the US Panel on Cost-Effectiveness in Health and Medicine recommendations. This recommendation is meant to improve comparability and consistency across studies (5). Furthermore, while a broad societal perspective will be adopted, results will also be presented using a narrower health system perspective that may be of key interest to health administrators and policy decision makers. This alternative perspective focuses on costs borne within the health system and excludes external costs as well as costs borne by patients and their caregivers.
Measured: 30 days
Patient satisfaction
Currently, there are no validated questionnaires that capture patient satisfaction with postoperative care. We have created a post-pilot survey that captures patient satisfaction with the care and information received. All answers are recorded using a 5-point likert scale. This will be captured at four-weeks after surgery. We will also use the QoR-9 scores and pain VAS scores recorded at one- and four-weeks postoperative. Psychometric properties of the QoR9 include convergent validity and discriminant construct validity. There is also good interrater agreement and internal consistency. The test-retest reliability was 0.61 (p<0.0001). The preferred cut-off is 0.7; however, the QoR9 was still favoured over the quality of recovery-40 (QoR40) questionnaire due to its ease of use (< 2 minutes required to complete the survey) (6). This will be captured in both groups at one- and four-weeks after surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Use of Mobile App Home Monitoring After Ambulatory SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- John Semple, MD, MSc, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318953
- Sponsor's protocol ID
- 2013 0094 B
- Status last verified
- Oct 2015
- First submitted
- 12 Dec 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23842982Jones 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.
PubMed 18025311Bailey 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.
PubMed 10396473Kazaure 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.
PubMed 23165614Siegel 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.
PubMed 8861994Myles 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.
PubMed 9895071Armstrong 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.
PubMed 28329223Armstrong 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.
PubMed 26040252