Pre/Post Pilot Test of Video Module Education
Primary Purpose
Chronic Obstructive Pulmonary Disease, Asthma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VME Group
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VME Group
Arm Description
Pre and post VME education group. The Intervention is the use of the virtual education module rather than the interpersonal educational strategy.
Outcomes
Primary Outcome Measures
Number of Participants With Inhaler Misuse Pre- and Post-VME
Assess patient's inhaler technique using Inhaler checklists by the trained assessor.
The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit
We will define inhaler technique in two ways:
Correct Use (i.e., >75% of steps correct)
Mastery (i.e., perfect technique, 100% steps correct)
Secondary Outcome Measures
Symptom Burden
Assess patient's respiratory symptoms/morbidity, which includes the Borg symptom score, Asthma Symptom Severity Index (ASSI), Chronic Bronchitis Symptom Questionnaire, COPD Severity Score (CSS), Airway Questionnaire (AQ-20), COPD Helplessness Index (CHI) and demographic and other clinical information.
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.
We will ask patients to report if they: strongly disagree/disagree/neutral/agree/strongly agree with the statement: "I am confident that I know how to use this respiratory inhaler correctly".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02278237
Brief Title
Pre/Post Pilot Test of Video Module Education
Official Title
Pre/Post Pilot Test of VME for the Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (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
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.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VME Group
Arm Type
Experimental
Arm Description
Pre and post VME education group. The Intervention is the use of the virtual education module rather than the interpersonal educational strategy.
Intervention Type
Behavioral
Intervention Name(s)
VME Group
Other Intervention Name(s)
Video Module Education (VME)
Intervention Description
Received inhaler education through VME (virtual education module)
Primary Outcome Measure Information:
Title
Number of Participants With Inhaler Misuse Pre- and Post-VME
Description
Assess patient's inhaler technique using Inhaler checklists by the trained assessor.
The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit
We will define inhaler technique in two ways:
Correct Use (i.e., >75% of steps correct)
Mastery (i.e., perfect technique, 100% steps correct)
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Symptom Burden
Description
Assess patient's respiratory symptoms/morbidity, which includes the Borg symptom score, Asthma Symptom Severity Index (ASSI), Chronic Bronchitis Symptom Questionnaire, COPD Severity Score (CSS), Airway Questionnaire (AQ-20), COPD Helplessness Index (CHI) and demographic and other clinical information.
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.
We will ask patients to report if they: strongly disagree/disagree/neutral/agree/strongly agree with the statement: "I am confident that I know how to use this respiratory inhaler correctly".
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
12. IPD Sharing Statement
Learn more about this trial
Pre/Post Pilot Test of Video Module Education
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