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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
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

    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

    First Posted
    October 10, 2014
    Last Updated
    June 3, 2019
    Sponsor
    University of Chicago
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    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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