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Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN) (E-TRaIN)

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teach-To-Goal
Brief Intervention
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease, Chronic Obstructive, Lung Disease, Obstructive, Self-management, Health Literacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Educational Intervention A

Educational Intervention B:

Arm Description

Intervention: Teach to Goal

Brief Intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Number of Participants With Acute Care Events 30 Days Post Discharge
Exacerbation/acute care events within one month of hospital discharge

Full Information

First Posted
August 29, 2011
Last Updated
November 6, 2019
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01426581
Brief Title
Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN)
Acronym
E-TRaIN
Official Title
Effectiveness of Interventions to Teach Respiratory Inhaler techNique (E-TRaIN)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease, Chronic Obstructive, Lung Disease, Obstructive, Self-management, Health Literacy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational Intervention A
Arm Type
Experimental
Arm Description
Intervention: Teach to Goal
Arm Title
Educational Intervention B:
Arm Type
Experimental
Arm Description
Brief Intervention
Intervention Type
Behavioral
Intervention Name(s)
Teach-To-Goal
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge
Description
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
Secondary Outcome Measure Information:
Title
Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events
Description
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
Title
Number of Participants With Self-Efficacy
Description
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
Title
Symptom Control
Description
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
Title
Number of Participants With Acute Care Events 30 Days Post Discharge
Description
Exacerbation/acute care events within one month of hospital discharge
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie G Press, MD, MPH
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26998961
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.
Results Reference
derived

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Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN)

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