Trial Outcomes & Findings for Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN) (NCT NCT01426581)

Results Overview

To evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI Devices one month after discharge home.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

1 month

Results posted on

2019-11-19

Participant Flow

Participants were randomized into TTG or BI between September 2011 and February 2013. Of the 120 participants, 100 were enrolled at hospital #1 and 20 were enrolled from hospital #2.

Participant milestones

Participant milestones
Measure	Teach To Goal Intervention: Teach to Goal Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)	Brief Intervention: Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
Overall Study STARTED	62	58
Overall Study COMPLETED	62	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Teach To Goal n=62 Participants Intervention: Teach to Goal Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)	Brief Intervention n=58 Participants Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)	Total n=120 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	54 Participants n=5 Participants	51 Participants n=7 Participants	105 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	41 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

To evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI Devices one month after discharge home.

Outcome measures

Outcome measures
Measure	Teach to Goal n=62 Participants Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)	Brief Intervention n=58 Participants Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge Misuse at Baseline	92 percentage	84 percentage
Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge Misuse at 30 days post-discharge	11 percentage	60 percentage

SECONDARY outcome

Timeframe: 1 month

Population: Out of 120 participants, 23 were screened to have less-than-adequate health literacy.

To determine the relative effectiveness of TTG compared to BI for patients with less-than-adequate health literacy using self-reported acute-care events 30 days post discharge. To measure less-than-adequate health literacy, the investigators administered the Short Test of Functional Health Literacy in Adults, a validated tool to assess whether a participant has adequate, marginal, or inadequate health literacy. Less-than-adequate included marginal and inadequate health literacy.

Outcome measures

Outcome measures
Measure	Teach to Goal n=13 Participants Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)	Brief Intervention n=10 Participants Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events	2 Participants	7 Participants

SECONDARY outcome

Timeframe: 1 month

This is a self-reported measure of how confident a participant is on how well they use their metered dose inhaler.

Outcome measures

Outcome measures
Measure	Teach to Goal n=62 Participants Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)	Brief Intervention n=58 Participants Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
Number of Participants With Self-Efficacy	49 Participants	38 Participants

SECONDARY outcome

Timeframe: 1 month

Population: The discrepancy from the number of participants in each group and the number of participants analyzed is due to missing data values due to lose to follow-up for the 30-day post discharge visit. 8 participants did not have values in the Teach To Goal group and 5 did not for the Brief Intervention group.

Symptom control will be assessed using interviewer-administered surveys. Using the Borg Dyspnea Scale, a validated Scale from 0 - 20 where 20 is maximal dyspnea, we took the difference between the the 30 day follow-up self reported shortness of breath from baseline to see if there was improvement in symptom control.

Outcome measures

Outcome measures
Measure	Teach to Goal n=54 Participants Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)	Brief Intervention n=53 Participants Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
Symptom Control	-1.69 units on a scale Standard Deviation 2.75	-1.43 units on a scale Standard Deviation 2.59

SECONDARY outcome

Timeframe: 1 month

Population: The discrepancy between the number of participants analyzed in each group and the number of participants in each arm total is due to lost to follow-up. In the Teach to Goal arm, 8 participants were lost to follow up and 5 participants were lost to follow up in the Brief Intervention arm.

Exacerbation/acute care events within one month of hospital discharge

Outcome measures

Outcome measures
Measure	Teach to Goal n=54 Participants Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)	Brief Intervention n=53 Participants Brief Intervention Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
Number of Participants With Acute Care Events 30 Days Post Discharge	9 Participants	19 Participants

Adverse Events

Educational Intervention A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Educational Intervention B:

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Valerie G. Press, MD, MPH

University of Chicago

Phone: 73-702-5170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place