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The purpose of this study is to evaluate the relative effectiveness of two different ways to teach subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge home from the hospital to determine durability of the education.
Teach-to-Goal (TTG) education employs instruction followed by patient "teach-back," then repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief Intervention (BI) education only consists of providing the patient with verbal and written instruction.
The investigators hypothesize that hospital-based TTG compared to BI increases a patient's ability to retain instructions on respiratory inhaler technique. The investigators will test this hypothesis separately for the MDI and Diskus® devices after discharge.
Respiratory inhalers are often used incorrectly by patients with obstructive lung disorders (including patients hospitalized with exacerbations of asthma or chronic obstructive pulmonary disease (COPD). As the mainstay of bronchodilator and anti-inflammatory therapy in patients with OLD, the implication of this difficulty with self-management is that patients are at risk for under-treatment and worse health outcomes. Several factors are thought to contribute to poor self-management skills, particularly inadequate patient education at healthcare encounters and inadequate patient health literacy. However, the most effective strategy to instruct patients about respiratory inhaler use in hospital settings is unclear, particularly in populations enriched with inadequate health literacy.
Therefore, the overall goal of this study is to evaluate the relative effectiveness of two hospital-based educational interventions: Teach-To-Goal (TTG, iterative cycles of demonstration-based education and assessment) versus Brief Intervention (BI, one-time set of verbal instructions) on the durability of instructions provided in the hospital and its effect on clinical outcomes (e.g., respiratory events and/or death), post hospital discharge. The investigators also plan to evaluate whether the relative effectiveness of TTG vs. BI varies by level of health literacy. The objectives of this proposal are to conduct a study in adults hospitalized with asthma/COPD to 1) to evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI and Diskus® devices after discharge home and 2) To determine the relative effectiveness of TTG compared to BI for patients with less-than-adequate health literacy compared to those with adequate health literacy. These data will inform the development of a larger, multi-center clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Intervention A | Experimental | Intervention: Teach to Goal |
|
| Educational Intervention B: | Experimental | Brief Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teach-To-Goal | Behavioral | Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge | To evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI Devices one month after discharge home. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events | To determine the relative effectiveness of TTG compared to BI for patients with less-than-adequate health literacy using self-reported acute-care events 30 days post discharge. To measure less-than-adequate health literacy, the investigators administered the Short Test of Functional Health Literacy in Adults, a validated tool to assess whether a participant has adequate, marginal, or inadequate health literacy. Less-than-adequate included marginal and inadequate health literacy. |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26998961 | Derived | Press VG, Arora VM, Trela KC, Adhikari R, Zadravecz FJ, Liao C, Naureckas E, White SR, Meltzer DO, Krishnan JA. Effectiveness of Interventions to Teach Metered-Dose and Diskus Inhaler Techniques. A Randomized Trial. Ann Am Thorac Soc. 2016 Jun;13(6):816-24. doi: 10.1513/AnnalsATS.201509-603OC. |
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Participants were randomized into TTG or BI between September 2011 and February 2013. Of the 120 participants, 100 were enrolled at hospital #1 and 20 were enrolled from hospital #2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teach To Goal | Intervention: Teach to Goal Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) |
| FG001 | Brief Intervention: | Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teach To Goal | Intervention: Teach to Goal Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) |
| 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 | Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge | To evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI Devices one month after discharge home. | Posted | Number | percentage | 1 month |
|
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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 | Educational Intervention A | Intervention: Teach to Goal Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie G. Press, MD, MPH | University of Chicago | 73-702-5170 | vpress@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Brief Intervention | Behavioral | Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) |
|
| 1 month |
| Number of Participants With Self-Efficacy | This is a self-reported measure of how confident a participant is on how well they use their metered dose inhaler. | 1 month |
| Symptom Control | Symptom control will be assessed using interviewer-administered surveys. Using the Borg Dyspnea Scale, a validated Scale from 0 - 20 where 20 is maximal dyspnea, we took the difference between the the 30 day follow-up self reported shortness of breath from baseline to see if there was improvement in symptom control. | 1 month |
| Number of Participants With Acute Care Events 30 Days Post Discharge | Exacerbation/acute care events within one month of hospital discharge | 1 month |
| BG001 | Brief Intervention | Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Brief Intervention |
Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) |
|
|
| Secondary | Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events | To determine the relative effectiveness of TTG compared to BI for patients with less-than-adequate health literacy using self-reported acute-care events 30 days post discharge. To measure less-than-adequate health literacy, the investigators administered the Short Test of Functional Health Literacy in Adults, a validated tool to assess whether a participant has adequate, marginal, or inadequate health literacy. Less-than-adequate included marginal and inadequate health literacy. | Out of 120 participants, 23 were screened to have less-than-adequate health literacy. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Number of Participants With Self-Efficacy | This is a self-reported measure of how confident a participant is on how well they use their metered dose inhaler. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Symptom Control | Symptom control will be assessed using interviewer-administered surveys. Using the Borg Dyspnea Scale, a validated Scale from 0 - 20 where 20 is maximal dyspnea, we took the difference between the the 30 day follow-up self reported shortness of breath from baseline to see if there was improvement in symptom control. | The discrepancy from the number of participants in each group and the number of participants analyzed is due to missing data values due to lose to follow-up for the 30-day post discharge visit. 8 participants did not have values in the Teach To Goal group and 5 did not for the Brief Intervention group. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
|
|
| Secondary | Number of Participants With Acute Care Events 30 Days Post Discharge | Exacerbation/acute care events within one month of hospital discharge | The discrepancy between the number of participants analyzed in each group and the number of participants in each arm total is due to lost to follow-up. In the Teach to Goal arm, 8 participants were lost to follow up and 5 participants were lost to follow up in the Brief Intervention arm. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Educational Intervention B: | Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) | 0 | 58 | 0 | 58 |
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| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |