Asthma, Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVME Group
Received inhaler education through VME (virtual education module)
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and older 2. Admission to the inpatient medical service and surgical service 3. Physician-diagnosed COPD or asthma. We will enroll patients even if the primary reason for admission is not COPD or asthma (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible).
Exclusion criteria
1. Currently in an intensive care unit 2. Physician declines to provide consent 3. Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Inhaler Misuse Pre- and Post-VME | Up to 30 days | 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: 1. Correct Use (i.e., \>75% of steps correct) 2. Mastery (i.e., perfect technique, 100% steps correct) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Burden | up to 30 days | 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. |
| Quality of Life (QOL) | up to 30 days | Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools) |
| Self-efficacy of Inhaler Technique | up to 30 days | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VME Group Video Module Education (VME) | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | VME Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
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: 1. Correct Use (i.e., \>75% of steps correct) 2. Mastery (i.e., perfect technique, 100% steps correct)
Time frame: Up to 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VME Group | Number of Participants With Inhaler Misuse Pre- and Post-VME | Misuse pre-VME | 83 participants |
| VME Group | Number of Participants With Inhaler Misuse Pre- and Post-VME | Misuse post-VME | 24 participants |
Secondary
Quality of Life (QOL)
Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools)
Time frame: up to 30 days
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.
Time frame: up to 30 days
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.
Time frame: up to 30 days