Post Operative ComplicationsICOUGHNCT03599037
Inpatient ICOUGH RECOVERY App Version 2.0
A study testing ICOUGH Recovery App v2.0 in people with Post Operative Complications and Pneumonia, run by Boston Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Complications, Pneumonia
- What is being tested?
- ICOUGH Recovery App v2.0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 19 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the ICOUGH RECOVERY App to Improve Protocol Adherence and Post-Operative Outcomes in the Inpatient Space
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.
Read the 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.
- Conditions
- Post Operative Complications, Pneumonia
- Being tested
- ICOUGH Recovery App v2.0
- Keywords
- ICOUGH Recovery App, Length of stay, Care coach, Incentive spirometry, Coughing, Post operative ambulation, Deep breathing, Smartphone
- Medical subject headings
- Pneumonia, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICOUGH Recovery App v2.0Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (4)
Length of stay
Length of inpatient stay in days will be abstracted from the participants' medical records.
Measured: 8 months
Postoperative pneumonia
Rate of postoperative pneumonia will be calculated from date abstracted from the participants' medical records.
Measured: 8 months
Unplanned intubation
Rates of unplanned intubation will be calculated from date abstracted from the participants' medical records.
Measured: 8 months
Death
Mortality rates will be calculated from date abstracted from the participants' medical records.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start7 Aug 2018
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
Why it stopped: The investigators decided not to start up the study after the long Covid 19 pause dring which no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative ComplicationsStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David McAneny, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599037
- Sponsor's protocol ID
- H-37554
- Acronym
- ICOUGH
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2018
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the ICOUGH RECOVERY App to Improve Protocol Adherence and Post-Operative Outcomes in the Inpatient Space
- ClinicalTrials.gov ID
- NCT03599037
- Acronym / sponsor ID
- ICOUGH / H-37554
- Conditions
- Post Operative Complications, Pneumonia
- Keywords
- ICOUGH Recovery App, Length of stay, Care coach, Incentive spirometry, Coughing, Post operative ambulation, Deep breathing, Smartphone
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators decided not to start up the study after the long Covid 19 pause dring which no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICOUGH Recovery App | Experimental | Other: ICOUGH Recovery App v2.0The 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Presence of neuromuscular disease or inability to perform all the measures in the ICOUGH protocol
- Visually impaired or blind
- Homeless
- Prisoner
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICOUGH Recovery App v2.0The 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. | Other | ICOUGH Recovery App |
Primary outcome
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.
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.
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.
4 secondary outcomes
Length of stay
Time frame: 8 months
Postoperative pneumonia
Time frame: 8 months
Unplanned intubation
Time frame: 8 months
Death
Time frame: 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David McAneny, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICOUGH Recovery App v2.0 in people with Post Operative Complications and Pneumonia, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to incentive spirometry (time frame: 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.