Clinical Trials Directory

Trials / Completed

CompletedNCT02278237

Pre/Post Pilot Test of Video Module Education

Pre/Post Pilot Test of VME for the Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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. 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. Over 75% of hospitalized patients in an urban, predominantly underserved population misused 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, several limitations prevent widespread adoption. TTG is time-consuming and costly. Also, 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) that has the potential to be less costly, maintain fidelity, and be more easily extended into the post-discharge setting than in-person TTG. 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. We hypothesize that interactive VME will lead to non-inferior rates of ability to demonstrate correct inhaler use compared to rates with TTG among hospitalized patients with Asthma or COPD. For this study we are testing the preliminary efficacy of VME to teach respiratory inhaler technique prior to implementing a larger RCT to test the comparative effectiveness of VME versus TTG.

Detailed description

The specific aim to test this hypothesis is: To iteratively test VME to teach correct use of metered dose inhaler (MDIs) and dry-powder Diskus® devices to hospitalized patients with Asthma or COPD. We partnered with software development companies to develop VME modules that (self)-assess and teach respiratory inhaler technique to hospitalized participants. We have tested the VME in focus groups. Now that the VME is developed we will iteratively pilot test (n=30-40) the VME strategy (up to 3 rounds (90-120 total)) to obtain important patient feedback,preferences and preliminary efficacy estimates for the module. We hypothesize that participants' post-VME inhaler technique will be significantly better than their pre-VME inhaler technique.

Conditions

Interventions

TypeNameDescription
BEHAVIORALVME GroupReceived inhaler education through VME (virtual education module)

Timeline

Start date
2014-11-01
Primary completion
2015-10-01
Completion
2015-10-01
First posted
2014-10-29
Last updated
2019-06-04
Results posted
2019-06-04

Source: ClinicalTrials.gov record NCT02278237. Inclusion in this directory is not an endorsement.