Trial Outcomes & Findings for Teaching Use of Respiratory Inhalers (TURI) (NCT NCT01456494)

NCT ID: NCT01456494

Last Updated: 2019-06-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 hour at the V0-V1 initial hospital study visit
• Results posted on: 2019-06-18

Participant Flow

Participant milestones

Measure	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. N=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. N=26
Initial Inpatient Visit STARTED	24	26
Initial Inpatient Visit COMPLETED	24	26
Initial Inpatient Visit NOT COMPLETED	0	0
Follow-Up Visit (Post 30-day Discharge) STARTED	24	26
Follow-Up Visit (Post 30-day Discharge) COMPLETED	19	20
Follow-Up Visit (Post 30-day Discharge) NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Teaching Use of Respiratory Inhalers (TURI)

Baseline characteristics by cohort

Measure	Teach-to-Goal n=24 Participants 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.	Brief Intervention n=26 Participants 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.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	56.4 years STANDARD_DEVIATION 19.0 • n=5 Participants	51.0 years STANDARD_DEVIATION 13.6 • n=7 Participants	53.8 years STANDARD_DEVIATION 16.4 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Measure	Teach-to-Goal n=24 Participants 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. N=24	Brief Intervention n=26 Participants 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. N=26
Number of Participants Misusing Metered-Dose Inhaler (MDI) Post Education Between Teach to Goal (TTG) and Brief Intervention (BI)	3 Participants	12 Participants

SECONDARY outcome

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

Outcome measures

Measure	Teach-to-Goal n=8 Participants 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. N=24	Brief Intervention n=10 Participants 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. N=26
Number of Participants Misusing Diskus Post Education Between TTG and BI	2 Participants	8 Participants

SECONDARY outcome

Timeframe: 30 days (Visits V0-V2, ie from initial hospital visit to the 30 day post discharge phone interview)

Outcome measures

Measure	Teach-to-Goal n=19 Participants 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. N=24	Brief Intervention n=20 Participants 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. N=26
Number of Participants Reporting Acute Health-related Events 30 Days Post Hospital Discharge Between TTG and BI	1 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Teach-to-Goal n=18 Participants 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. N=24	Brief Intervention n=18 Participants 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. N=26
Self-reported Confidence With Inhaler Technique Versus Actual Technique	6 Participants	5 Participants

Adverse Events

Teach-to-Goal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brief Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary Akel

University of Chicago

Phone: 773-834-4489

Email: makel@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place