PackHealth: Asthma Engagement Tool

Study Overview
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Brief Summary
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The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.

Detailed Description
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Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective. The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions. Pack Health LLC and Duke will develop a patient engagement toolkit known as Packs to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials

Official Title
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Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Patient engagement toolkit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a physician diagnosis of asthma for at least the previous 12 months. Asthma that is not well controlled by NAEPP guidelines. Ability and willingness to provide informed consent Exclusion Criteria: Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse. Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled. A diagnosis of cancer with ongoing treatment. Any terminal illness or conditions that results in a life expectancy less than one year.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Asthma Patients<br>Patient engagement toolkit | Behavioral: Patient engagement toolkit<br>* Pack Health LLC and Duke will develop a patient engagement toolkit known as Packs to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Asthma Exacerbations | The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline. | 12 weeks prior to baseline | 
| Rate of Asthma Exacerbations | The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13 | baseline to week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Asthma Control | Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5 items with 4-week recall. The score range is 5-25 with >19 representing good control and <18 representing poor control. | baseline, 13 weeks | 
| Change in Asthma Symptoms | Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall. Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09 | baseline, 13 weeks | 
| Change in Pulmonary Function Tests | Measured by spirometry. We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters. FEV1 is a measure of airflow obstruction. The change in lung function is the change in these measurements compared to baseline. | baseline, 13 weeks | 
| Number of Emergency Department and Hospitalization Visits | Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year. | Prior Year | 
| Number of Emergency Department and Hospitalization Visits | Number of emergency department and hospitalization visits will be recorded | 13 weeks |