Clinical trial NCT03599037: Inpatient ICOUGH RECOVERY App Version 2.0
Official title: Use of the ICOUGH RECOVERY App to Improve Protocol Adherence and Post-Operative Outcomes in the Inpatient Space
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Operative Complications
Pneumonia
Keywords: ICOUGH Recovery App
Length of stay
Care coach
Incentive spirometry
Coughing
Post operative ambulation
Deep breathing
Smartphone
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing emergent general surgery with the Acute Care Surgery service
* English speaker with the ability to read English at 5th grade level
* Able to ambulate, with or without assistance

Exclusion Criteria:

* Presence of neuromuscular disease or inability to perform all the measures in the ICOUGH protocol
* Visually impaired or blind
* Homeless
* Prisoner
* Pregnancy
* Body mass index \< 15 kg/m-2 or \> 54 kg/m-2

Primary outcomes:
measure: Adherence to incentive spirometry
timeFrame: 8 months
measure: Adherence to oral health
timeFrame: 8 months
measure: Adherence to ambulation
timeFrame: 8 months
Secondary outcomes:
measure: Length of stay
timeFrame: 8 months
measure: Postoperative pneumonia
timeFrame: 8 months
measure: Unplanned intubation
timeFrame: 8 months
measure: Death
timeFrame: 8 months
Other outcomes:
measure: Usability score
timeFrame: 8 months
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: David McAneny, MD
role: PRINCIPAL_INVESTIGATOR
References: