Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03599037
Study type Interventional
Source Boston Medical Center
Contact
Status Withdrawn
Phase N/A
Start date August 7, 2018
Completion date July 19, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Completed NCT05815264 - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above Phase 1
Recruiting NCT04589936 - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care N/A
Completed NCT02905383 - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital N/A
Terminated NCT03944551 - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa N/A
Completed NCT06210737 - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months,7 Months-5 Years Phase 4
Terminated NCT04660084 - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT04171674 - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation. N/A
Active, not recruiting NCT03140163 - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR] N/A
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT02638649 - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Recruiting NCT02515565 - Physiotherapy in Patients Hospitalized Due to Pneumonia. N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01399723 - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia Phase 3
Completed NCT01416519 - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Terminated NCT02358642 - Drug to Prevent Pneumonia in the Tube Fed Phase 4
Completed NCT01416506 - Community-Acquired Pneumonia (CAP) Surveillance N/A