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Inpatient ICOUGH RECOVERY App Version 2.0

Use of the ICOUGH RECOVERY App to Improve Protocol Adherence and Post-Operative Outcomes in the Inpatient Space

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03599037
Acronym
ICOUGH
Enrollment
0
Registered
2018-07-26
Start date
2018-08-07
Completion date
2021-07-19
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Post Operative Complications

Keywords

ICOUGH Recovery App, Length of stay, Care coach, Incentive spirometry, Coughing, Post operative ambulation, Deep breathing, Smartphone

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.

Interventions

OTHERICOUGH Recovery App v2.0

The app has pre-set auditory, visual reminders, in the form of push notifications, that remind participants to use the incentive spirometer and ambulate around the hospital at time intervals recommended by the ICOUGH protocol. The app benchmarks the level of adherence to that of other subjects involved in the study via the My Summary page, and this visual anonymous comparison further motivates adherence to the ICOUGH protocol.

Sponsors

Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to oral health8 monthsPost operative daily oral care rates for ICOUGH app users will be calculated from the ICOUGH Recovery app database for those participants who use the app.
Adherence to ambulation8 monthsPost operative daily ambulation rates for ICOUGH app users will be calculated from the ICOUGH Recovery app database for those participants who use the app.
Adherence to incentive spirometry8 monthsPost operative daily incentive spirometry rates will be calculated from the ICOUGH Recovery app database for those participants who use the app.

Secondary

MeasureTime frameDescription
Unplanned intubation8 monthsRates of unplanned intubation will be calculated from date abstracted from the participants' medical records.
Death8 monthsMortality rates will be calculated from date abstracted from the participants' medical records.
Length of stay8 monthsLength of inpatient stay in days will be abstracted from the participants' medical records.
Postoperative pneumonia8 monthsRate of postoperative pneumonia will be calculated from date abstracted from the participants' medical records.

Other

MeasureTime frameDescription
Usability score8 monthsA modified System Usability Scale which is a 10 item questionnaire with Likert-style questions with five responses (0 to 4) that range from 'Strongly Disagree' to 'Strongly Agree' will to be completed by participants who use the ICOUGH app. The participant's scores for each question will be converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. A score above a 68 is considered above average and anything below 68 is below average.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026