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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Module Education (VME)
Teach-To-Goal (TTG)
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

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

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video Module Education (VME)

Teach-To-Goal (TTG)

Arm Description

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.

Participants assigned to the TTG condition will be provided with an intensive, iterative education and evaluation strategy that consists of the following steps.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Symptom burden
Symptom burden will be assessed using interviewer-administered surveys
Quality of Life (QOL)
Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools)
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."
Utilization of health care services (outpatient visits, ED and hospital admissions, deaths)
Lung function
Assess patient's lung function via spirometry

Full Information

First Posted
November 18, 2015
Last Updated
May 23, 2018
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02611531
Brief Title
Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN (V-TRaIN)
Official Title
Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN (V-TRaIN)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video Module Education (VME)
Arm Type
Experimental
Arm Description
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.
Arm Title
Teach-To-Goal (TTG)
Arm Type
Active Comparator
Arm Description
Participants assigned to the TTG condition will be provided with an intensive, iterative education and evaluation strategy that consists of the following steps.
Intervention Type
Behavioral
Intervention Name(s)
Video Module Education (VME)
Intervention Description
Participants will complete inhaler education on a tablet device
Intervention Type
Behavioral
Intervention Name(s)
Teach-To-Goal (TTG)
Intervention Description
Participants will complete intensive in-person inhaler education
Primary Outcome Measure Information:
Title
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.
Description
Assess patient's inhaler technique using Inhaler checklists by the trained assessor.
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Symptom burden
Description
Symptom burden will be assessed using interviewer-administered surveys
Time Frame
Up to 30 days
Title
Quality of Life (QOL)
Description
Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools)
Time Frame
up to 30 days
Title
self-efficacy of inhaler technique
Description
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."
Time Frame
up to 30 days
Title
Utilization of health care services (outpatient visits, ED and hospital admissions, deaths)
Time Frame
Up to 30 days
Title
Lung function
Description
Assess patient's lung function via spirometry
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older Admission to the inpatient medical service and surgical service 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: 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
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
31899529
Citation
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.
Results Reference
derived

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

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