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Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million hospitalizations in the United States annually and COPD is the third leading cause of 30-day re-hospitalizations. Clinical trials have established the efficacy of treatments primarily dispensed via respiratory inhaler devices that reduce morbidity and health care utilization if they are used correctly. The effectiveness of these medications in real-world settings is limited by the fact that patients often do not use inhalers correctly. Current guidelines recommend assessing and teaching inhaler technique at all health care encounters, including hospitalization. Over 75% of hospitalized patients in an urban, predominantly underserved population misused their respiratory inhalers, highlighting a missed opportunity to educate these patients with high potential to benefit. Hospitalization, therefore, provides a potential 'teachable moment' to correct this misuse. My preliminary data indicate that one strategy, in-person teach-to-goal (TTG), is effective in teaching hospitalized patients proper inhaler technique and is more effective than simple verbal instruction. While TTG is a promising, several limitations prevent widespread adoption. TTG is time-consuming and costly. Also, reinforcement may be needed, which may be impractical with in-person TTG. One potential method to surmount TTG's limitations is use of interactive video module education (VME) that has the potential to be less costly, maintain fidelity, and be more easily extended into the post-discharge setting than in-person TTG. Before widespread implementation of VME, it is critical to rigorously develop and test VME for inhaler education in the hospital setting. Ultimately, it will also be important to understand patients' ability and willingness to use post-discharge VME for educational reinforcement to allow for this strategy to transition patients across care settings from hospital to home.
We hypothesize that interactive VME will lead to non-inferior rates of ability to demonstrate correct inhaler use compared to rates with TTG among hospitalized patients with Asthma or COPD.
For this study we are testing the preliminary efficacy of VME to teach respiratory inhaler technique prior to implementing a larger RCT to test the comparative effectiveness of VME versus TTG.
The specific aim to test this hypothesis is:
To iteratively test VME to teach correct use of metered dose inhaler (MDIs) and dry-powder Diskus® devices to hospitalized patients with Asthma or COPD. We partnered with software development companies to develop VME modules that (self)-assess and teach respiratory inhaler technique to hospitalized participants. We have tested the VME in focus groups. Now that the VME is developed we will iteratively pilot test (n=30-40) the VME strategy (up to 3 rounds (90-120 total)) to obtain important patient feedback,preferences and preliminary efficacy estimates for the module.
We hypothesize that participants' post-VME inhaler technique will be significantly better than their pre-VME inhaler technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VME Group | Experimental | Pre and post VME education group. The Intervention is the use of the virtual education module rather than the interpersonal educational strategy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VME Group | Behavioral | Received inhaler education through VME (virtual education module) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Inhaler Misuse Pre- and Post-VME | Assess patient's inhaler technique using Inhaler checklists by the trained assessor. The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit We will define inhaler technique in two ways:
| Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Burden | Assess patient's respiratory symptoms/morbidity, which includes the Borg symptom score, Asthma Symptom Severity Index (ASSI), Chronic Bronchitis Symptom Questionnaire, COPD Severity Score (CSS), Airway Questionnaire (AQ-20), COPD Helplessness Index (CHI) and demographic and other clinical information. | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie G. Press, MD, MPH | University of Chicago | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | VME Group | Video Module Education (VME): The RE will provide participants with a tablet device and will demonstrate how to access VME and complete the pre/post e-learning assessments. The RE will provide technical support but will neither participate directly in the education nor help with the self-assessments. The participants will first complete the pre-assessment e-learning tool on the tablet. They will then watch the video instruction that will provide a complete demonstration with verbal instructions on correct inhaler technique. Next the participants will complete the post-assessment e-learning tool. Based on participants' performance, they will be directed to further tailored video-instruction. The cycle of self-assessment and video instruction will continue until sufficient mastery has been achieved. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VME Group | Video Module Education (VME) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Inhaler Misuse Pre- and Post-VME | Assess patient's inhaler technique using Inhaler checklists by the trained assessor. The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit We will define inhaler technique in two ways:
| Posted | Number | participants | Up to 30 days |
|
|
Adverse event data were collected through study completion, which was up to 30 days.
Based on the nature of the study, we foresee that the risk for participation does not exceed the risks of typical daily activities. We expect that a patient's All-Cause Mortality does not change based on their inclusion in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VME Group | Video Module Education (VME) | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie G. Press, MD, MPH | University of Chicago | 773-702-5170 | vpress@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Quality of Life (QOL) |
Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools) |
| up to 30 days |
| Self-efficacy of Inhaler Technique | Assess patient's confidence in using their inhalers. We will ask patients to report if they: strongly disagree/disagree/neutral/agree/strongly agree with the statement: "I am confident that I know how to use this respiratory inhaler correctly". | up to 30 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Symptom Burden | Assess patient's respiratory symptoms/morbidity, which includes the Borg symptom score, Asthma Symptom Severity Index (ASSI), Chronic Bronchitis Symptom Questionnaire, COPD Severity Score (CSS), Airway Questionnaire (AQ-20), COPD Helplessness Index (CHI) and demographic and other clinical information. | Not Posted | up to 30 days | Participants |
| Secondary | Quality of Life (QOL) | Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools) | Not Posted | up to 30 days | Participants |
| Secondary | Self-efficacy of Inhaler Technique | Assess patient's confidence in using their inhalers. We will ask patients to report if they: strongly disagree/disagree/neutral/agree/strongly agree with the statement: "I am confident that I know how to use this respiratory inhaler correctly". | Not Posted | up to 30 days | Participants |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |