Trial Outcomes & Findings for Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma (NCT NCT00414817)

Last Updated: 2017-01-30

Results Overview

We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.

Recruitment status

COMPLETED

Study phase

Target enrollment

14064 participants

Primary outcome timeframe

Measured over 19 months

Results posted on

2017-01-30

Participant Flow

Recruitment occurred, starting in October 2007 via electronic medical record query. Calling campaigns ended in April 2009.

14,064 adults taking medication for asthma were pre-randomized to intervention or usual care (UC). However, only those individuals who ever qualified for an intervention call were included in the analysis sample. This included 6905 pre-existing inhaled corticosteroid (ICS) users (our primary analysis sample) and 1612 new ICS users.

Participant milestones

Participant milestones
Measure	Automated Phone-Based Refill Reminders Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.	Usual Care Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention.
Overall Study STARTED	7033	7031
Overall Study Never Started on ICS	1465	1392
Overall Study Died or Left Health Plan	451	417
Overall Study Adherent ICS User	922	900
Overall Study Daily Oral Steroid User	117	123
Overall Study <3 Months Follow-up	175	184
Overall Study COMPLETED	3903	4015
Overall Study NOT COMPLETED	3130	3016

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Automated Phone-Based Refill Reminders n=3171 Participants Intervention arm participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.	Usual Care n=3260 Participants usual care participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.	Total n=6431 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	2394 Participants n=5 Participants	2499 Participants n=7 Participants	4893 Participants n=5 Participants
Age, Categorical >=65 years	777 Participants n=5 Participants	761 Participants n=7 Participants	1538 Participants n=5 Participants
Age, Continuous	53.7 years STANDARD_DEVIATION 15.3 • n=5 Participants	53.5 years STANDARD_DEVIATION 15.3 • n=7 Participants	53.6 years STANDARD_DEVIATION 15.3 • n=5 Participants
Gender Female	2150 Participants n=5 Participants	2207 Participants n=7 Participants	4357 Participants n=5 Participants
Gender Male	1021 Participants n=5 Participants	1053 Participants n=7 Participants	2074 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1169 Participants n=5 Participants	1185 Participants n=7 Participants	2354 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1959 Participants n=5 Participants	2036 Participants n=7 Participants	3995 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) Asian	342 Participants n=5 Participants	388 Participants n=7 Participants	730 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	145 Participants n=5 Participants	130 Participants n=7 Participants	275 Participants n=5 Participants
Race (NIH/OMB) Black or African American	51 Participants n=5 Participants	52 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) White	1632 Participants n=5 Participants	1578 Participants n=7 Participants	3210 Participants n=5 Participants
Race (NIH/OMB) More than one race	196 Participants n=5 Participants	235 Participants n=7 Participants	431 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	789 Participants n=5 Participants	857 Participants n=7 Participants	1646 Participants n=5 Participants
Region of Enrollment United States	3171 participants n=5 Participants	3260 participants n=7 Participants	6431 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured over 19 months

Population: Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.

Outcome measures

Outcome measures
Measure	Automated Phone-Based Refill Reminders n=3171 Participants Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.	Usual Care n=3260 Participants Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention.
Modified Medication Possession Ratio	.40 fraction of days with medication Standard Deviation .32	.38 fraction of days with medication Standard Deviation .32

SECONDARY outcome

Timeframe: Measured at 19 months

Population: We assessed this outcome on a random sample of study participants that over-sampled intervention participants. All were existing users of ICS at the outset of the study who qualified for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.

Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.

Outcome measures

Outcome measures
Measure	Automated Phone-Based Refill Reminders n=921 Participants Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.	Usual Care n=501 Participants Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention.
Juniper Asthma Quality of Life Questionnaire (Global Score)	4.8 unitless scale ranging from 1-7 Standard Deviation 1.3	4.9 unitless scale ranging from 1-7 Standard Deviation 1.3

SECONDARY outcome

Timeframe: Measured over 19 months of follow-up

annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.

Outcome measures

Outcome measures
Measure	Automated Phone-Based Refill Reminders n=3171 Participants Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.	Usual Care n=3260 Participants Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention.
Rate of Acute Health Care Visits for Asthma	1.7 number of events per year Standard Deviation 2.3	1.7 number of events per year Standard Deviation 2.0

Adverse Events

Automated Phone-Based Refill Reminders

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Dr. William Vollmer, Senior Investigator

Kaiser Permanente, Center for Health Research

Phone: 503-335-6755

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place