Inpatient ICOUGH RECOVERY App Version 2.0

NCT03599037 | Withdrawn

• 1 other identifier: H-37554
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Complications; Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  8 months

• 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.

  8 months

• 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.

  8 months

Secondary Outcomes (4)

• Length of stay

  8 months

• Postoperative pneumonia

  8 months

• Unplanned intubation

  8 months

• Death

  8 months

Other Outcomes (1)

• Usability score

  8 months

Study Arms (2)

ICOUGH Recovery App

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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.

Interventions

ICOUGH Recovery App v2.0 OTHER

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.

ICOUGH Recovery App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Pneumonia; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David McAneny, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 26, 2018
• Study Start: August 7, 2018
• Primary Completion: July 19, 2021
• Study Completion: July 19, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)