search
Back to results

Teaching Use of Respiratory Inhalers (TURI) (TURI)

Primary Purpose

Asthma, COPD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention
Teach-to-Goal Education
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Obstructive Lung Disease, COPD, Asthma, Inhaler, Metered-Dose Inhaler, Education, Hospital-based education

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years and older
  • Admission to the inpatient medical service and surgical service
  • Physician-diagnosed asthma or COPD
  • Physician plans to discharge patients home on a metered dose inhaler (MDI; e.g., albuterol)

Exclusion Criteria:

  • Currently in an intensive care unit
  • Physician declines to provide consent
  • Patient unable to provide assent (history of cognitive impairment, unable to understand English), or declines to provide consent
  • Previous participant in this study

Sites / Locations

  • University of Chicago Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Teach-to-Goal

Brief Intervention

Arm Description

Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.

A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.

Outcomes

Primary Outcome Measures

Number of Participants Misusing Metered-Dose Inhaler (MDI) Post Education Between Teach to Goal (TTG) and Brief Intervention (BI)

Secondary Outcome Measures

Number of Participants Misusing Diskus Post Education Between TTG and BI
Number of Participants Reporting Acute Health-related Events 30 Days Post Hospital Discharge Between TTG and BI
Differences in the Prevalence of Reported Acute Health-related Events 90 Days Post Hospital Discharge Between TTG and BI
Self-reported Confidence With Inhaler Technique Versus Actual Technique
For all patients, the investigators compared their baseline self-reported confidence using a 5-point Likert scale and whether they used their inhaler correctly. The investigators define having strong confidence as either "Agree" or "Strongly Agree" when responding to "I know how to use my inhaler correctly." The investigators define correct technique as performing 10 out of 12 steps in the inhaler technique checklist. The following statistic for each arm is for the participants who reported being confident in their inhaler technique, the number of that sub-population that demonstrated satisfactory inhaler technique

Full Information

First Posted
October 14, 2011
Last Updated
June 17, 2019
Sponsor
University of Chicago
search

1. Study Identification

Unique Protocol Identification Number
NCT01456494
Brief Title
Teaching Use of Respiratory Inhalers (TURI)
Acronym
TURI
Official Title
Teaching Use of Respiratory Inhalers (TURI)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the feasibility of enrolling and randomizing patients into one of two educational interventions to teach appropriate respiratory inhaler technique and to collect preliminary estimates of the comparative effectiveness of two types of education. Teach-to-Goal (TTG) education employs instruction followed by patient "teach-back," then repeated cycles of learning and assessment until a skill, i.e. respiratory inhaler technique, is mastered. By contrast, Brief Intervention (BI) education only consists of providing the patient with verbal and written instruction on the skill, i.e., respiratory inhaler technique. The investigators hypothesize that hospital-based TTG compared to BI increases a patient's ability to learn respiratory inhaler technique. The investigators will test this hypothesis separately for the MDI and Diskus® devices.
Detailed Description
Respiratory inhalers are often used incorrectly by hospitalized patients with asthma or chronic obstructive pulmonary disease (COPD). As the mainstay of bronchodilator and anti-inflammatory therapy for these patients, the implication of this difficulty with self-management is that patients are at risk for under-treatment and worse health outcomes. Several factors are thought to contribute to poor self-management skills, particularly inadequate patient education at healthcare encounters and inadequate patient health literacy (HL; ability to understand and use healthcare instructions). Inadequate HL in patients with asthma leads to worse knowledge about medications in general and inhaler technique specifically, and patients with inadequate HL are more likely to be hospitalized. As a result, national and international guidelines for both asthma and COPD recommend patient education to improve self-management skills regarding use of respiratory inhalers and assessing patient comprehension at all points of care, including hospitals. However, the most effective strategy to instruct patients about respiratory inhaler use in hospital settings is unclear, particularly in populations enriched with inadequate HL. Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching and assessments of patient comprehension until mastery is confirmed. Our preliminary data in hospitalized patients suggest that TTG may be a particularly powerful method to teach this high-risk population how to use respiratory inhalers correctly, including patients with inadequate HL. However, TTG is likely to be more resource-intensive (personnel training and time) than approaches used in everyday clinical settings (usual care). Further, the relative magnitude of the effectiveness of TTG compared to other less resource-intensive methods on patient comprehension and health outcomes is not known. As healthcare resources are limited, empiric data about the comparative effectiveness of TTG and alternate approaches of patient education are needed. Therefore this pilot comparative effectiveness study will compare the TTG approach versus a brief intervention (BI) for patients hospitalized with asthma or COPD to evaluate the feasibility of conducting a randomized clinical trial of two educational interventions in this population and to collect preliminary estimates of the relative benefits of TTG vs. BI. These data will help inform the design of subsequent larger studies of comparative effectiveness. The primary research goal is to evaluate the feasibility of conducting a randomized clinical trial of two different strategies to teach respiratory inhaler use and to determine preliminary estimates of effect size for the interventions; specifically, the investigators will assess our recruitment and retention rates, pilot test case reports and other study procedures and to evaluate the resources (staff & investigator time, costs for patient incentives and other study materials) needed to perform the trial. These data will inform subsequent studies by providing important information regarding feasibility, effect size for sample calculations and preliminary data to secure funding for the development of further research. The Specific Aims are: Specific Aim 1: To evaluate the feasibility of enrolling and randomizing patients into an educational intervention to teach appropriate respiratory inhaler technique. Specific Aim 2: To obtain a preliminary estimate of the effect size of TTG vs. BI in order to determine the necessary sample size for a larger comparative effectiveness study designed to improve health outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD
Keywords
Obstructive Lung Disease, COPD, Asthma, Inhaler, Metered-Dose Inhaler, Education, Hospital-based education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teach-to-Goal
Arm Type
Experimental
Arm Description
Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.
Arm Title
Brief Intervention
Arm Type
Experimental
Arm Description
A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.
Intervention Type
Other
Intervention Name(s)
Brief Intervention
Other Intervention Name(s)
BI
Intervention Description
A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.
Intervention Type
Other
Intervention Name(s)
Teach-to-Goal Education
Other Intervention Name(s)
TTG
Intervention Description
Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.
Primary Outcome Measure Information:
Title
Number of Participants Misusing Metered-Dose Inhaler (MDI) Post Education Between Teach to Goal (TTG) and Brief Intervention (BI)
Time Frame
1 hour at the V0-V1 initial hospital study visit
Secondary Outcome Measure Information:
Title
Number of Participants Misusing Diskus Post Education Between TTG and BI
Time Frame
1 hour at the V0-V1 initial hospital study visit
Title
Number of Participants Reporting Acute Health-related Events 30 Days Post Hospital Discharge Between TTG and BI
Time Frame
30 days (Visits V0-V2, ie from initial hospital visit to the 30 day post discharge phone interview)
Title
Differences in the Prevalence of Reported Acute Health-related Events 90 Days Post Hospital Discharge Between TTG and BI
Time Frame
90 days (from Visits V0-V3, ie from initial hospital visit to 90 days day post discharge phone interview)
Title
Self-reported Confidence With Inhaler Technique Versus Actual Technique
Description
For all patients, the investigators compared their baseline self-reported confidence using a 5-point Likert scale and whether they used their inhaler correctly. The investigators define having strong confidence as either "Agree" or "Strongly Agree" when responding to "I know how to use my inhaler correctly." The investigators define correct technique as performing 10 out of 12 steps in the inhaler technique checklist. The following statistic for each arm is for the participants who reported being confident in their inhaler technique, the number of that sub-population that demonstrated satisfactory inhaler technique
Time Frame
1 hour at Visits V0-V1 initial hospital study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and older Admission to the inpatient medical service and surgical service Physician-diagnosed asthma or COPD Physician plans to discharge patients home on a metered dose inhaler (MDI; e.g., albuterol) Exclusion Criteria: Currently in an intensive care unit Physician declines to provide consent Patient unable to provide assent (history of cognitive impairment, unable to understand English), or declines to provide consent Previous participant in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie G Press, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Teaching Use of Respiratory Inhalers (TURI)

We'll reach out to this number within 24 hrs