View Clinical Trial (Medical Research Study)
Effectiveness of Interventions to Teach Respiratory Inhaler techNique (E-TRaIN)
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60637 |
| Conditions: |
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Asthma - Chronic Obstructive Pulmonary Disease (COPD) |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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Inclusion Criteria:
- 18 years and older
- Admitting diagnosis of asthma or COPD
- Physican- diagnosed asthma, asthma/COPD, or COPD. We will enroll patients even if the
primary reason for admission is not asthma or COPD (e.g., patients admitted for heart
failure, but with a physician diagnosis of COPD are eligible)
- Patient will be discharged home on a Metered Dose Inhaler (MDI; e.g., albuterol)
Exclusion Criteria:
- Currently in an intensive care unit
- Physician declines to provide consent
- Patient unable to provide consent (e.g., history of cognitive impairment, unable to
understand English) or declines to provide consent
- Previous participant in this study
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| NCT ID: |
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NCT01426581 |
| Primary Contact: |
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Principal Investigator
Valerie G Press, MD, MPH
University of Chicago
Kristin L Constantine, BA
Phone: 773-834-1985
Email: kconstantine@medicine.bsd.uchicago.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60637
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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