The Digital Incentive Spirometer (DIS): Improving Adherence to Incentive Spirometry

Study Overview
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Brief Summary
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The purpose of the protocol is to assess how incentive spirometer data gathered via a smartphone platform can be utilized to improve participant adherence to prescribed incentive spirometer exercises in the post-operative period. Half of the participants will receive a standard of care incentive spirometer with a passive tracking device while the other half of the participants will receive a smartphone connected device and smartphone with an application that will encourage their use.

Detailed Description
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This study is a prospective, randomized, participant blinded, single center, clinical trial to ascertain whether a smartphone connected digital incentive spirometer, the Smartpeakflow™, can improve participant adherence to prescribed incentive spirometer exercises. A control group will be given the Beth Israel Deaconess Medical Center (BIDMC) standard Voldyne Incentive Spirometer with an attached microcontroller that will record use of the spirometer. The study group will be given the Smartpeakflow ™ connected to an android motherboard (microcomputer, aka smartphone) running Android OS, that will then record use and store this data on the smartphone itself. Participants will then use an app on the BIDMC provided smartphone to view their usage and receive encouragement to continue using their device. All data on use will be recorded locally and there will be no internet connection or communication with participant through this device at any time. The study is designed as a technology evaluation to assess feasibility, usability and assess for early impact on our outcome measures. The investigators plan to enroll up to 50 participants to participate in this study. At the time of enrollment, participants who meet the inclusion criteria, and none of the exclusion criteria, will be asked to opt in to the study. Participants will read information about the study and research staff will explain what it means to opt in. Prospective participants will be given ample time to read the informed consent form and ask any questions. Once enrolled, participants will be randomized electronically to either the study group or control group. Participants that are randomized to the control group will have no further training or instructions at the Pre-Anesthesia Testing Clinic. Participants that are in the study group will be instructed on how to use the smartphone application and device which will then be provided to them in the Post Anesthesia Care Unit after their surgery. Both groups will retain and utilize the spirometers throughout their hospital stay, and the devices will be collected by the investigators when the participant is discharged from the hospital.

Official Title
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A Behavioral Study of Digital Technology for Improving Post-Operative Incentive Spirometer Adherence

Conditions
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Post-Op Infection, Adherence, Patient, Pulmonary Atelectasis, Incentive Spirometry, Post-Op Complication

Intervention / Treatment
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* Behavioral: Smartphone Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists Physical Class (ASA) 1-3 patients undergoing elective Surgery at BIDMC requiring Incentive Spirometer use in the post-op period Greater than 18 years of age. Required to have a Pre-Anesthesia Testing Clinic Appointment Able to understand and sign a study consent form Able to understand and utilize a smartphone application Exclusion Criteria: Diagnosis of Obstructive Sleep Apnea (OSA), treatment with CPAP or BIPAP for OSA Lack of regular smartphone use, or visual, mental or motor impairment that impedes use of smartphone Upper extremity surgery resulting in temporary or permanent inability to use two hands with spirometer device ASA 4 or greater, any ASA-E status (emergency surgical procedure) Suspected or established respiratory infection Previous spontaneous pneumothorax Severe pulmonary disease, or use of home O2 Does not speak or understand English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be enrolled randomly into either the passive arm or the smartphone arm prior to their surgery.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Passive Arm<br>This arm uses a passive tracking device to assess the number of times a patient uses their prescribed incentive spirometer. | |
| Experimental: Smartphone Arm<br>This arm uses a smartphone connected device and smartphone application to remind and encourage patients to use the spirometer as well as track the number of times they utilize the spirometer. | Behavioral: Smartphone Arm<br>* The smartphone arm will have an associated smartphone application, available in kiosk mode, that will remind and encourage patient to utilize the spirometer and provide a gamified application for that patient to do so.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to prescribed post-operative incentive spirometer exercises | The primary outcome of the study will be a measure of how adherent the participant has been to the prescribed post-operative incentive spirometer exercises. Participants are prescribed ten breathing exercises per hour using the spirometer and the electronic devices in both arms will record how often the participant utilizes the device, measured on an hourly basis. | Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-Operative Pulmonary Complications | Pulmonary related complications and events such as radiographic exams, increased utilization of oxygen therapy, use of accessory breathing devices (BiPAP, CPAP). The measure will be dichotomous outcome based on whether event took place or not. | Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner. | 
| Incidence of post-operative respiratory infection | Diagnosis of respiratory infection, such as pneumonia, in the post-operative period. The measure will be dichotomous outcome based on whether event took place or not. | Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner. | 
| Incidence of clinically relevant complications | Diagnosis of clinically relevant complications such as surgical site infection, falls, delerium, or any other non-pulmonary event in the post-operative period. The measure will be dichotomous outcome based on whether event took place or not. | Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory therapy, Pulmonary Atelectasis, perioperative medicine, incentive spirometry, smartphone