Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN (V-TRaIN)

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Asthma
• Interventions: Behavioral: Video Module Education (VME); Behavioral: Teach-To-Goal (TTG)

• Registration Number: NCT02611531
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of this study is to evaluate the 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.

Detailed Description

Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million hospitalizations in the United States annually and COPD is the third leading cause of 30-day re-hospitalizations. Clinical trials have established the efficacy of treatments primarily dispensed via respiratory inhaler devices that reduce morbidity and health care utilization if they are used correctly. Unfortunately, the effectiveness of these medications in real-world settings is limited by the fact that patients often do not use inhalers correctly. Current guidelines recommend assessing and teaching inhaler technique at all health care encounters, including hospitalization. My work has found that over 75% of hospitalized patients in an urban, predominantly underserved population misuse their respiratory inhalers, highlighting a missed opportunity to educate these patients with high potential to benefit. Hospitalization, therefore, provides a potential 'teachable moment' to correct this misuse. My preliminary data indicate that one strategy, in-person teach-to-goal (TTG), is effective in teaching hospitalized patients proper inhaler technique and is more effective than simple verbal instruction.

While TTG is a promising method to improve care for patients who use inhalers, several limitations prevent widespread adoption. First, TTG relies on in-person assessment and education, as well as training and monitoring instructors to ensure fidelity, making it time-consuming and costly. Also, because a single educational session does not ensure long-term retention, post-discharge reinforcement may be needed, which may be impractical with in-person TTG. One potential method to surmount TTG's limitations is use of interactive video module education (VME), a method that has been used for health education in other clinical contexts. Through iterative self-assessments and video-demonstrations on a tablet computer, VME has the potential to be less costly, maintain fidelity, and be more easily extended into the post-discharge setting than in-person TTG. However, certain questions remain about VME. It is unclear whether VME will yield similar results when compared to TTG, or whether patients will have the ability to, and be willing to use, VME in the post-discharge setting. Therefore, before widespread implementation of VME, it is critical to rigorously develop and test VME for inhaler education in the hospital setting. Ultimately, it will also be important to understand patients' ability and willingness to use post-discharge VME for educational reinforcement to allow for this strategy to transition patients across care settings from hospital to home.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Age 18 years and older
2. Admission to the inpatient medical service and surgical service
3. Physician-diagnosed COPD or asthma. We will enroll patients even if the primary reason for admission is not COPD or asthma (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible).

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Exclusion Criteria

1. Currently in an intensive care unit
2. Physician declines to provide consent
3. Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Module Education (VME)	Video Module Education (VME)	The RE will provide participants with a tablet device and will demonstrate how to access VME and complete the pre/post e-learning assessments. The RE will provide technical support but will neither participate directly in the education nor help with the self-assessments. The participants will first complete the pre-assessment e-learning tool on the tablet. They will then watch the video instruction that will provide a complete demonstration with verbal instructions on correct inhaler technique. Next the participants will complete the post-assessment e-learning tool. Based on participants' performance, they will be directed to further tailored video-instruction. The cycle of self-assessment and video instruction will continue until sufficient mastery has been achieved.
Teach-To-Goal (TTG)	Teach-To-Goal (TTG)	Participants assigned to the TTG condition will be provided with an intensive, iterative education and evaluation strategy that consists of the following steps.

Primary Outcome Measures

Name	Time	Method
The proportion of participants with metered dose inhaler (MDI) misuse post VME vs. TTG education. This will provide data on the short-term effectiveness of the interventions.	Up to 30 days	Assess patient's inhaler technique using Inhaler checklists by the trained assessor.

Secondary Outcome Measures

Name	Time	Method
self-efficacy of inhaler technique	up to 30 days	Assess patient's confidence in using their inhalers using a Likert scale response to the question "I am confident that I know how to use this respiratory inhaler correctly."
Lung function	Up to 30 days	Assess patient's lung function via spirometry
Symptom burden	Up to 30 days	Symptom burden will be assessed using interviewer-administered surveys
Quality of Life (QOL)	up to 30 days	Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools)
Utilization of health care services (outpatient visits, ED and hospital admissions, deaths)	Up to 30 days

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States