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Teaching Use of Respiratory Inhalers (TURI)

Teaching Use of Respiratory Inhalers (TURI)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01456494
Acronym
TURI
Enrollment
50
Registered
2011-10-20
Start date
2009-07-31
Completion date
2010-07-31
Last updated
2019-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD

Keywords

Obstructive Lung Disease, COPD, Asthma, Inhaler, Metered-Dose Inhaler, Education, Hospital-based education

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.

Interventions

OTHERBrief Intervention

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.

OTHERTeach-to-Goal Education

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.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Participants Misusing Metered-Dose Inhaler (MDI) Post Education Between Teach to Goal (TTG) and Brief Intervention (BI)1 hour at the V0-V1 initial hospital study visit

Secondary

MeasureTime frameDescription
Number of Participants Misusing Diskus Post Education Between TTG and BI1 hour at the V0-V1 initial hospital study visit
Number of Participants Reporting Acute Health-related Events 30 Days Post Hospital Discharge Between TTG and BI30 days (Visits V0-V2, ie from initial hospital visit to the 30 day post discharge phone interview)
Differences in the Prevalence of Reported Acute Health-related Events 90 Days Post Hospital Discharge Between TTG and BI90 days (from Visits V0-V3, ie from initial hospital visit to 90 days day post discharge phone interview)
Self-reported Confidence With Inhaler Technique Versus Actual Technique1 hour at Visits V0-V1 initial hospital study visitFor 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Teach-to-Goal
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. Teach-to-Goal Education: 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.
24
Brief Intervention
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. Brief Intervention: 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.
26
Total50

Baseline characteristics

CharacteristicTotalTeach-to-GoalBrief Intervention
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
13 Participants9 Participants4 Participants
Age, Categorical
Between 18 and 65 years
37 Participants15 Participants22 Participants
Age, Continuous53.8 years
STANDARD_DEVIATION 16.4
56.4 years
STANDARD_DEVIATION 19
51.0 years
STANDARD_DEVIATION 13.6
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants23 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
37 Participants16 Participants21 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
11 Participants7 Participants4 Participants
Region of Enrollment
United States
50 participants24 participants26 participants
Sex: Female, Male
Female
34 Participants16 Participants18 Participants
Sex: Female, Male
Male
16 Participants8 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 243 / 26
other
Total, other adverse events
0 / 240 / 26
serious
Total, serious adverse events
0 / 240 / 26

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Teach-to-GoalNumber of Participants Misusing Metered-Dose Inhaler (MDI) Post Education Between Teach to Goal (TTG) and Brief Intervention (BI)3 Participants
Brief InterventionNumber of Participants Misusing Metered-Dose Inhaler (MDI) Post Education Between Teach to Goal (TTG) and Brief Intervention (BI)12 Participants
Secondary

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)

Population: Due to lost to follow-up, the investigators did not collect and analyze acute health related events 90 days post discharge.

Secondary

Number of Participants Misusing Diskus Post Education Between TTG and BI

Time frame: 1 hour at the V0-V1 initial hospital study visit

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Teach-to-GoalNumber of Participants Misusing Diskus Post Education Between TTG and BI2 Participants
Brief InterventionNumber of Participants Misusing Diskus Post Education Between TTG and BI8 Participants
Secondary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Teach-to-GoalNumber of Participants Reporting Acute Health-related Events 30 Days Post Hospital Discharge Between TTG and BI1 Participants
Brief InterventionNumber of Participants Reporting Acute Health-related Events 30 Days Post Hospital Discharge Between TTG and BI8 Participants
Secondary

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

Time frame: 1 hour at Visits V0-V1 initial hospital study visit

Population: For the TTG arm, 18 out of 24 individuals self-reported being confident in their inhaler technique. In the BI arm, 18 out of 26 reported being confident in their inhaler technique.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Teach-to-GoalSelf-reported Confidence With Inhaler Technique Versus Actual Technique6 Participants
Brief InterventionSelf-reported Confidence With Inhaler Technique Versus Actual Technique5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026