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Inpatient ICOUGH RECOVERY App Version 2.0 (ICOUGH)

Primary Purpose

Post Operative Complications, Pneumonia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICOUGH Recovery App v2.0
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Complications focused on measuring ICOUGH Recovery App, Length of stay, Care coach, Incentive spirometry, Coughing, Post operative ambulation, Deep breathing, Smartphone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICOUGH Recovery App

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adherence to incentive spirometry
Post operative daily incentive spirometry rates will be calculated from the ICOUGH Recovery app database for those participants who use the app.
Adherence to oral health
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.
Adherence to ambulation
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

Length of stay
Length of inpatient stay in days will be abstracted from the participants' medical records.
Postoperative pneumonia
Rate of postoperative pneumonia will be calculated from date abstracted from the participants' medical records.
Unplanned intubation
Rates of unplanned intubation will be calculated from date abstracted from the participants' medical records.
Death
Mortality rates will be calculated from date abstracted from the participants' medical records.

Full Information

First Posted
July 15, 2018
Last Updated
July 19, 2021
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03599037
Brief Title
Inpatient ICOUGH RECOVERY App Version 2.0
Acronym
ICOUGH
Official Title
Use of the ICOUGH RECOVERY App to Improve Protocol Adherence and Post-Operative Outcomes in the Inpatient Space
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The investigators decided not to start up the study after the long Covid 19 pause dring which no participants were enrolled.
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
July 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Complications, Pneumonia
Keywords
ICOUGH Recovery App, Length of stay, Care coach, Incentive spirometry, Coughing, Post operative ambulation, Deep breathing, Smartphone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICOUGH Recovery App
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ICOUGH Recovery App v2.0
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to incentive spirometry
Description
Post operative daily incentive spirometry rates will be calculated from the ICOUGH Recovery app database for those participants who use the app.
Time Frame
8 months
Title
Adherence to oral health
Description
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.
Time Frame
8 months
Title
Adherence to ambulation
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Length of stay
Description
Length of inpatient stay in days will be abstracted from the participants' medical records.
Time Frame
8 months
Title
Postoperative pneumonia
Description
Rate of postoperative pneumonia will be calculated from date abstracted from the participants' medical records.
Time Frame
8 months
Title
Unplanned intubation
Description
Rates of unplanned intubation will be calculated from date abstracted from the participants' medical records.
Time Frame
8 months
Title
Death
Description
Mortality rates will be calculated from date abstracted from the participants' medical records.
Time Frame
8 months
Other Pre-specified Outcome Measures:
Title
Usability score
Description
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.
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David McAneny, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inpatient ICOUGH RECOVERY App Version 2.0

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