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Inpatient ICOUGH RECOVERY App Version 2.0 (ICOUGH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599037
Recruitment Status : Suspended (Currently suspended due to Covid-19 policies.)
First Posted : July 26, 2018
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

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.


Condition or disease Intervention/treatment Phase
Post Operative Complications Pneumonia Other: ICOUGH Recovery App v2.0 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of the ICOUGH RECOVERY App to Improve Protocol Adherence and Post-Operative Outcomes in the Inpatient Space
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICOUGH Recovery App
The ICOUGH Recovery app v2.0 will be downloaded to participants who have a smartphone and want to use the app after their surgery. These participants will be instructed to use the app daily after their surgery until discharge and to select a care coach. Prior to discharge subjects will complete a questionnaire to assess usability and will participate in a brief recorded interview of their experience using the app. Inpatient post operative complications will be abstracted from medical records.
Other: ICOUGH 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.

No Intervention: Standard of care
Participants who either do not have a smartphone or have a smartphone but don't want to use the app will receive the standard of care after surgery which includes an ICOUGH protocol checklist. Inpatient post operative complications will be abstracted from medical records.



Primary Outcome Measures :
  1. Adherence to incentive spirometry [ Time Frame: 8 months ]
    Post operative daily incentive spirometry rates will be calculated from the ICOUGH Recovery app database for those participants who use the app.

  2. Adherence to oral health [ Time Frame: 8 months ]
    Post 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.

  3. Adherence to ambulation [ Time Frame: 8 months ]
    Post operative daily ambulation rates for ICOUGH app users will be calculated from the ICOUGH Recovery app database for those participants who use the app.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 8 months ]
    Length of inpatient stay in days will be abstracted from the participants' medical records.

  2. Postoperative pneumonia [ Time Frame: 8 months ]
    Rate of postoperative pneumonia will be calculated from date abstracted from the participants' medical records.

  3. Unplanned intubation [ Time Frame: 8 months ]
    Rates of unplanned intubation will be calculated from date abstracted from the participants' medical records.

  4. Death [ Time Frame: 8 months ]
    Mortality rates will be calculated from date abstracted from the participants' medical records.


Other Outcome Measures:
  1. Usability score [ Time Frame: 8 months ]
    A 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599037


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: David McAneny, MD Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT03599037    
Other Study ID Numbers: H-37554
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
ICOUGH Recovery App
Length of stay
Care coach
Incentive spirometry
Coughing
Post operative ambulation
Deep breathing
Smartphone
Additional relevant MeSH terms:
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Pneumonia
Postoperative Complications
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes