An interventional study of Teach-To-Goal and Brief Intervention in Asthma and Chronic Obstructive Pulmonary Disease (COPD), sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by University of Chicago · Not applicable, Interventional, and Other
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
Intervention: Teach to Goal
Behavioral: Teach-To-Goal
Brief Intervention
Behavioral: Brief Intervention
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)
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)
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.
Time frame: 1 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month
Number of Participants With Acute Care Events 30 Days Post Discharge
Exacerbation/acute care events within one month of hospital discharge
Time frame: 1 month
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.
| Milestone | Teach To Goal | Brief Intervention: |
|---|---|---|
| Started | 62 | 58 |
| Completed | 62 | 58 |
| Not completed | 0 | 0 |
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.
| percentage | Teach to Goal | Brief Intervention |
|---|---|---|
| Misuse at Baseline | 92 | 84 |
| Misuse at 30 days post-discharge | 11 | 60 |
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.
| Participants | Teach To Goal | Brief Intervention |
|---|---|---|
| Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events | 2 | 7 |
This is a self-reported measure of how confident a participant is on how well they use their metered dose inhaler.
| Participants | Teach To Goal | Brief Intervention: |
|---|---|---|
| Number of Participants With Self-Efficacy | 49 | 38 |
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.
| units on a scale | Teach To Goal | Brief Intervention: |
|---|---|---|
| Symptom Control | -1.69 ± 2.75 | -1.43 ± 2.59 |
Exacerbation/acute care events within one month of hospital discharge
| Participants | Teach To Goal | Brief Intervention: |
|---|---|---|
| Number of Participants With Acute Care Events 30 Days Post Discharge | 9 | 19 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Educational Intervention A | — | 0/62 (0%) | 0/62 (0%) |
| Educational Intervention B: | — | 0/58 (0%) | 0/58 (0%) |
| Age, Categorical(Participants) | Teach To Goal | Brief Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 54 | 51 | 105 |
| >=65 years | 8 | 7 | 15 |
| Sex: Female, Male(Participants) | Teach To Goal | Brief Intervention | Total |
|---|---|---|---|
| Female | 47 | 41 | 88 |
| Male | 15 | 17 | 32 |
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