Teaching Use of Respiratory Inhalers (TURI)

NCT01456494 | Completed Results DMC

• 1 other identifier: 16900A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; COPD

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Misusing Diskus Post Education Between TTG and BI

  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

  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

  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

  1 hour at Visits V0-V1 initial hospital study visit

Study Arms (2)

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.

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.

Other: Brief Intervention

Interventions

Brief Intervention OTHER

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.

Also known as: BI

Brief Intervention

Teach-to-Goal Education OTHER

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.

Also known as: TTG

Teach-to-Goal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Mary Akel
• Organization: University of Chicago

makel@medicine.bsd.uchicago.edu

773-834-4489

Study Officials

• Valerie G Press, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: October 20, 2011
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 18, 2019
• Results First Posted: June 18, 2019

Record last verified: 2018-05

Locations

US (1)