Clinical trial NCT01426581: Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN)
Official title: Effectiveness of Interventions to Teach Respiratory Inhaler techNique (E-TRaIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Lung Disease, Obstructive
Self-management
Health Literacy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Admitting diagnosis of asthma or COPD
* Physician- 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

Primary outcomes:
measure: Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge
timeFrame: 1 month
Secondary outcomes:
measure: Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events
timeFrame: 1 month
measure: Number of Participants With Self-Efficacy
timeFrame: 1 month
measure: Symptom Control
timeFrame: 1 month
measure: Number of Participants With Acute Care Events 30 Days Post Discharge
timeFrame: 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Valerie G Press, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.