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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611531
• Other study ID #: 12-1844
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Video Module Education (VME)
Participants will complete inhaler education on a tablet device
• Teach-To-Goal (TTG)
Participants will complete intensive in-person inhaler education

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

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