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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma
• Intervention / Treatment: Behavioral: Video Module Education (VME); Behavioral: Teach-To-Goal (TTG)

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Video Module Education (VME); Participants will complete inhaler education on a tablet device
Active Comparator: 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.	Behavioral: Teach-To-Goal (TTG); Participants will complete intensive in-person inhaler education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assess patient's inhaler technique using Inhaler checklists by the trained assessor.	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom burden	Symptom burden will be assessed using interviewer-administered surveys	Up to 30 days
Quality of Life (QOL)	Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools)	up to 30 days
self-efficacy of inhaler technique	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."	up to 30 days
Utilization of health care services (outpatient visits, ED and hospital admissions, deaths)		Up to 30 days
Lung function	Assess patient's lung function via spirometry	Up to 30 days

Collaborators and Investigators

• Sponsor: University of Chicago

Publications and helpful links

General Publications

• Press VG, Arora VM, Kelly CA, Carey KA, White SR, Wan W. Effectiveness of Virtual vs In-Person Inhaler Education for Hospitalized Patients With Obstructive Lung Disease: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1918205. doi: 10.1001/jamanetworkopen.2019.18205.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 12-1844