Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03599037 |
| Other study ID # |
H-37554 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 7, 2018 |
| Est. completion date |
July 19, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Boston Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This pilot study will evaluate how well version 2 of the ICOUGH app, a bed-side mobile app
increases patients' adherence to a postoperative protocol called ICOUGH. Specific outcomes,
such as length of hospital stay, postoperative lung complications, unplanned intubations, and
death will be assessed in participants who do and those who do not use the ICOUGH Recovery
app, positing that a smartphone intervention should improve these outcomes over time.
ICOUGH is a mnemonic that stands for each step of a protocol shown to decrease lung-related
complications of surgery. It stands for Incentive spirometry (a breathing device that expands
the lungs), Coughing and deep breathing, Oral hygiene, Understanding (patient and family
education), Getting out of bed at least three times daily, and Head-of-bed elevation.
The ICOUGH protocol was developed at Boston Medical Center (BMC) and has been shown to
improve patient outcomes by decreasing postoperative pneumonia by 38%, unplanned intubations
by 40%, and all adverse outcomes by 40%, which has resulted in over $5 million in cost
savings for BMC in a two-year period. There is an instructional paper pamphlet with intuitive
pictures for each step of ICOUGH, and patient subjects can log how many times they've done
each step.
Description:
The purpose of this study is to determine the feasibility of and adherence to all parts of
version 2 of the ICOUGH app, incorporating user feedback and repairing "bugs" discovered
during the previous trial. It will also compare postoperative complications and length of
stay in participants who used and those who did not use the ICOUGH app. Eligible participants
who have a smartphone will decide whether they want to download and use the ICOUGH app or
not. Those who choose not to use the app and participants who do not have a smartphone, will
receive the postoperative standard of care ICOUGH pamphlet which lists the activities that
patients are encouraged to do following surgery to prevent lung complications.
The app incorporates a number of functionalities that encourage subject accountability to the
ICOUGH protocol. The participant will be given the option to choose one person from his/her
smartphone contact list (friend or family member) to be his/her "care coach." The care coach
will first receive an initial text regarding the role of a care coach, which is to help the
subject adhere to the ICOUGH protocol. Should the care coach accept this role, he/she will
also receive text message updates on the subject's level of adherence to the ICOUGH protocol
three times during the day. The care coach is encouraged to help the subject comply with the
treatment plan, which he/she can easily do through texting, phone calls, and hospital visits.
The patient will be informed of the role and expectations for a care coach during their
initial pre-operative assessment clinic visit, prior to consenting. The app will not transmit
any private data pertaining to the selected care coach (e.g., name, phone number, etc.) to
the back-end server. The concept and function of a care coach is unique to the app and is not
ordinarily part of the standard of care.
The app also has pre-set auditory, visual reminders-in the form of push notifications-that
remind the subject to use the incentive spirometer and ambulate around the hospital at time
intervals recommended by the ICOUGH protocol. Every time the subject interacts with the app,
whether by touching its push notifications or interacting with a tablet computer at the
nursing station, these interactions can be visualized on the main screen via an intuitive
dashboard. Lastly, the app conveniently benchmarks the subject's level of adherence to that
of other subjects involved in the study via the "My Summary" page, and this visual comparison
is meant to be a form of friendly competition against other (anonymous) patients to further
motivate adherence to the protocol.
Following discharge, the research team will perform a retrospective chart review to record
participants' length of stay (LOS), development of postoperative pulmonary complications, and
other objective data. for participants used and those who did not use the ICOUGH Recovery
app.
