Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Chronic Obstructive Pulmonary Disease (COPD) |
Behavioral: Teach-To-Goal Behavioral: Brief Intervention |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Effectiveness of Interventions to Teach Respiratory Inhaler techNique (E-TRaIN) |
- Ability to Retain Instructions About Correct Use of MDI within a month after Hospital Discharge [ Time Frame: 1 month ] [ Designated as safety issue: No ]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.
- Role of Health Literacy [ Time Frame: 1 month ] [ Designated as safety issue: No ]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
- Self-Efficacy [ Time Frame: 1 month ] [ Designated as safety issue: No ]Self-Efficacy change over time
- Symptom control [ Time Frame: 1 month ] [ Designated as safety issue: No ]Symptom control will be assessed using interviewer-administered surveys
- Acute Care Events [ Time Frame: 1 month ] [ Designated as safety issue: No ]Exacerbation/acute care events within one month of hospital discharge
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Educational Intervention A
Intervention: Teach to Goal
|
Behavioral: 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)
|
|
Experimental: Educational Intervention B:
Brief Intervention
|
Behavioral: 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)
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Kristin L Constantine, BA | 773-834-1985 | kconstantine@medicine.bsd.uchicago.edu |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | Valerie G Press, MD, MPH | University of Chicago |
More Information
No publications provided
| Responsible Party: | Valerie Press, Instructor, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01426581 History of Changes |
| Other Study ID Numbers: | 11-0248 |
| Study First Received: | August 29, 2011 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Asthma Chronic Obstructive Pulmonary Disease (COPD) Pulmonary Disease, Chronic Obstructive |
Lung Disease, Obstructive Self-management Health Literacy |
Additional relevant MeSH terms:
|
Asthma Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases |
Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013