Trial Outcomes & Findings for Using Information Technology to Improve Asthma Adherence (NCT NCT00459368)

Results Overview

Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2698 participants

Primary outcome timeframe

1 year

Results posted on

2010-08-17

Participant Flow

Health system primary care providers (i.e., in the areas of family practice, internal medicine, and pediatrics) were invited to participate. Physicians who consented to participate were grouped according to practice.

One hundred ninety-two (92%) of the 207 primary care staff clinicians, representing 34 pre-defined primary care practices within the health system, agreed to participate. One clinic was not included a priori since it functioned as the primary resident clinic for internal medicine trainees.

Participant milestones

Participant milestones
Measure	Patient Medication Adherence Feedback In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.	Usual Care Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
Overall Study STARTED	1335	1363
Overall Study COMPLETED	1040	1034
Overall Study NOT COMPLETED	295	329

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Information Technology to Improve Asthma Adherence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Medication Adherence Feedback n=1335 Participants In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.	Usual Care n=1363 Participants Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.	Total n=2698 Participants Total of all reporting groups
Age, Categorical <=18 years	591 Participants n=5 Participants	604 Participants n=7 Participants	1195 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	744 Participants n=5 Participants	759 Participants n=7 Participants	1503 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	25.6 years STANDARD_DEVIATION 37.3 • n=5 Participants	27.7 years STANDARD_DEVIATION 38.5 • n=7 Participants	26.6 years STANDARD_DEVIATION 37.9 • n=5 Participants
Sex: Female, Male Female	737 Participants n=5 Participants	753 Participants n=7 Participants	1490 Participants n=5 Participants
Sex: Female, Male Male	598 Participants n=5 Participants	610 Participants n=7 Participants	1208 Participants n=5 Participants
Region of Enrollment United States	1335 participants n=5 Participants	1363 participants n=7 Participants	2698 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.

Outcome measures

Outcome measures
Measure	Patient Medication Adherence Feedback n=1335 Participants In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.	Usual Care n=1363 Participants Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
Patient Adherence to Inhaled Corticosteroids (ICS)	21.3 Percent of ICS medication taken Standard Deviation 2.5	23.3 Percent of ICS medication taken Standard Deviation 2.2

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

L. Keoki Williams, MD, MPH

Henry Ford Health System

Phone: 313-874-5454

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place