AsthmaTURINCT01456494
Teaching Use of Respiratory Inhalers (TURI)
A study testing Brief Intervention and Teach-to-Goal Education in people with Asthma and COPD, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Brief Intervention and Teach-to-Goal Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
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.
Read the 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.
- Being tested
- Brief Intervention, Teach-to-Goal Education
- Keywords
- Obstructive Lung Disease, COPD, Asthma, Inhaler, Metered-Dose Inhaler, Education, Hospital-based education
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionOther
Also called BI
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.
Teach-to-Goal EducationOther
Also called TTG
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.
| Study group | Role | What they receive |
|---|---|---|
| Teach-to-Goal | Experimental | 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. Receives: Other: Teach-to-Goal Education |
| Brief Intervention | Experimental | 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. Receives: Other: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Misusing Metered-Dose Inhaler (MDI) Post Education Between Teach to Goal (TTG) and Brief Intervention (BI)
Measured: 1 hour at the V0-V1 initial hospital study visit
Secondary outcomes (4)
Number of Participants Misusing Diskus Post Education Between TTG and BI
Measured: 1 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 BI
Measured: 30 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 BI
Measured: 90 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 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
Measured: 1 hour at Visits V0-V1 initial hospital study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie G Press, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456494
- Sponsor's protocol ID
- 16900A
- Acronym
- TURI
- Status last verified
- May 2018
- First submitted
- 14 Oct 2011
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Use of Respiratory Inhalers (TURI)
- ClinicalTrials.gov ID
- NCT01456494
- Acronym / sponsor ID
- TURI / 16900A
- Keywords
- Obstructive Lung Disease, COPD, Asthma, Inhaler, Metered-Dose Inhaler, Education, Hospital-based education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Posted 18 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teach-to-Goal | Experimental | Other: Teach-to-Goal EducationTeach-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. |
| Brief Intervention | Experimental | Other: Brief InterventionA brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief InterventionAlso: BIA brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers. | Other | Brief Intervention |
| Teach-to-Goal EducationAlso: TTGTeach-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. | Other | Teach-to-Goal |
Primary outcome
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
4 secondary outcomes
Number of Participants Misusing Diskus Post Education Between TTG and BI
Time frame: 1 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 BI
Time frame: 30 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 BI
Time frame: 90 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 Technique
Time frame: 1 hour at Visits V0-V1 initial hospital study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie G Press, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention and Teach-to-Goal Education in people with Asthma and COPD, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.