Evaluation of COPD Co-Pilot

Study Overview
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Brief Summary
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The purpose of this research study is to investigate the potential benefits of participant use of a smartphone application (App) called COPD Co-Pilot™. When used by the participant, COPD Co-Pilot™ may provide early detection of worsening COPD symptoms. Early symptom detection may allow the pulmonary providers and nurses to respond with timely medical advice and treatment. The goal for use of COPD Co-Pilot™ is to reduce the frequency and duration of hospitalizations, emergency department visits, and hospital readmissions. The study will also examine the financial impact of the COPD Co-Pilot™ program to determine whether costs of hospital stays, emergency department visits, and hospital readmissions differ when patients are enrolled in COPD Co-Pilot™ than when they are not enrolled. Another purpose of this study is to measure patient satisfaction with use of COPD Co-Pilot™.

Detailed Description
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During the 6-month observational period, subjects will report respiratory symptoms using COPD Co-Pilot on a daily basis and will receive feedback and clinical recommendations from their health care provider when their symptoms change from their baseline symptoms. Final clinical recommendations, medical advice, diagnoses, and treatment are in the full and sole discretion of the provider. All subjects will receive current standard of care under the supervision of their health care provider. No experimental drugs, dosages, or treatment protocols will be administered at any stage during this trial. Subjects will receive monthly calls to determine whether any changes to the subject's medical history, hospitalization history, medications, etc. have occurred so they may be added to the subject's profile. At approximately 6 months post enrollment, all subjects will have an in person end of study visit.

Official Title
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Evaluation of COPD Co-Pilot

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: COPD Co-Pilot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has read, understood and signed an informed consent form prior to enrollment. Males or females age ≥35 years old Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV) Must be able to read and understand English and consent for themselves Subject is willing and able to use an iPad mini device. Exclusion Criteria: Subject has had an acute exacerbation of COPD that required hospitalization or ER visit or treatment with systemic steroids and/or antibiotics during the 28 days prior to enrollment. • Subjects who had a COPD exacerbation within 28 days prior to Visit 1 can be rescreened once. Rescreening can occur no earlier than 28 days from the last dose of systemic steroids and/or antibiotics and/or hospitalization, whichever is later Subject has a COPD exacerbation or respiratory illness during the Run-In period that in the judgment of the investigator requires medical intervention (e.g., treatment with systemic steroids and/or antibiotics and/or hospitalization). • Subjects who had a COPD exacerbation or infection during the Run-In period can be rescreened once. Rescreening can occur no earlier than 28 days from the last dose of systemic steroid and/or antibiotics and/or hospitalization, whichever is later. Subject is suffering from terminal illness expected to adversely affect survival in the next 12 months Subject has a history of non-compliance with medical therapies Subject has a cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage Subject is currently known to suffer from or have a history of significant substance abuse within the last 2 years Subject has any condition that in the opinion of the provider may adversely affect their participation Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities Subject has a planned procedures at time of enrollment that will occur within timeframe of study that will require hospitalization or otherwise adversely affect their ability to participate Subject may, in the opinion of the provider, be non-compliant with study schedules or procedures Subject has no cellular coverage at their primary residence Subject plans to travel to a location with no cellular coverage for a significant period (>1 week) during their program participation

Ages Eligible for Study
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Minimum Age: 35 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: COPD Co-Pilot|The COPD Co-PilotTM is a smartphone application for symptom reporting supported by a Call Center staffed with pulmonary nurses and Health Assistants who are trained to support patients with COPD. The call center staff are employees and subcontractors of the company that makes the COPD Co-PilotTM, HGE. It is located on the Campus of Temple University in Philadelphia Pennsylvania.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Adoption | Percentage of potential daily symptom reports completed by patients | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | patient satisfaction questionnaire | 6 months | 
| Inpatient Admissions | admission records for period prior to study and during study | 6 months | 
| Emergency department visits | emergency department records for period prior to study and during study | 6 months | 
| Clinic visits | clinic visits for period prior to study and during study | 6 months | 
| Patient reported respiratory symptoms | Daily values for breathlessness, sputum quantity, sputum color, sputum consistency, peak flow, temperature over 100 F, cough, wheeze, sore throat, and nasal congestion. | 6 months | 
| Symptom change detected | Change index (a numeric value) and the categorical level of change that corresponds to the patient's reported symptoms when compared to their baseline. This is recorded for each daily symptom report submitted after completion of the run-in period. | 6 months | 
| Episode duration | the date when a mild, moderate or significant level of change is first detected for a patient through the date immediately followed by seven consecutive days in which a level of no change (i.e. return to baseline) is detected. The total number of days in this period, symptoms reported during this period, and clinical responses communicated to the patient (including any treatments or changes) will be reported for analysis. | 6 months | 
| Time to clinical responses | Time elapsed between the patient's check-in and the time the response was acknowledged by the patient. | 6 months | 
| Hospitalization history | hospitalization history reported to Health Assistants by patients during scheduled monthly phone calls. This will be reconciled with admissions data from the site and may include utilization at other institutions. | 6 months | 
| Medications | list of medications and changes entered by site coordinator, provider, or reported by subjects to Health Assistants during scheduled monthly phone calls. | 6 months | 
| Patient profile information | This will include, among other variables, medical history, smoking history, spirometry results, oxygen use, and diagnoses of co-morbidities. For a full list of profile data, please see the appendix. | 6 months | 
| Medication compliance | compliance with newly prescribed treatments as reported by patients during follow up phone calls. | 6 months | 
| Length of stay | total number of inpatient days per admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient date of birth (DOB), location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. Reported for period prior to study and during study period | 6 months | 
| Readmissions | The number of inpatient admissions that occur within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis, diagnosis at discharge, and associated costs broken down by category. This will be reported for time prior to study and during study period. | 6 months | 
| Readmission rate | The rate and percent of inpatient admissions that occur within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. These will be reported for the period prior to the start of the study through the study period. | 6 months | 
| Source of inpatient admissions and visits to the Emergency Department (ED) | The source (e.g. from home, from accident, from outpatient clinical, at direction of physician, from ED, etc.) of each and every inpatient admission and emergency department visit will be reported for analyses. These will be reported for the period prior to the enrollment through the study period. | 6 months | 
| Cost of Care | Costs associated with hospitalizations, emergency department visits, clinic visits, and medications | 6 months | 
| Historic utilization | hospitalizations, emergency department visits, clinic visits in the 6 months prior to enrollment; and hospitalizations, emergency department visits, clinic visits in the same 6 month period during the prior year | 6 months | 
| Historic costs | costs associated with hospitalizations, emergency department visits, clinic visits in the 6 months prior to enrollment; and costs associated with hospitalizations, emergency department visits, clinic visits in the same 6 month period during the prior year | 6 months |