Trial Outcomes & Findings for Adherence and Intensification of Medications (AIM) Implementation Study (NCT NCT00495794)

NCT ID: NCT00495794

Last Updated: 2015-04-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4622 participants
• Primary outcome timeframe: 6 months prior to 6 months after the intervention period
• Results posted on: 2015-04-28

Participant Flow

Participant milestones

Measure	Pharmacist Management Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing) Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms	Usual Care Eligible patients receive usual care
Overall Study STARTED	2319	2303
Overall Study COMPLETED	1797	2303
Overall Study NOT COMPLETED	522	0

Reasons for withdrawal

Measure	Pharmacist Management Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing) Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms	Usual Care Eligible patients receive usual care
Overall Study Pharmacist did not activate patient	522	0

Baseline Characteristics

Adherence and Intensification of Medications (AIM) Implementation Study

Baseline characteristics by cohort

Measure	Pharmacist Management n=1797 Participants Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing) Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms	Usual Care n=2303 Participants Eligible patients receive usual care	Total n=4100 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 11.7 • n=5 Participants	65.3 years STANDARD_DEVIATION 12.1 • n=7 Participants	65.3 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	547 Participants n=5 Participants	721 Participants n=7 Participants	1268 Participants n=5 Participants
Sex: Female, Male Male	1250 Participants n=5 Participants	1582 Participants n=7 Participants	2832 Participants n=5 Participants
Region of Enrollment United States	1797 participants n=5 Participants	2303 participants n=7 Participants	4100 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months prior to 6 months after the intervention period

Population: intention to treat analysis

Outcome measures

Measure	Pharmacist Management n=1693 Participants Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing) Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms	Usual Care n=2162 Participants Eligible patients receive usual care
Change in Systolic Blood Pressure	-8.9 mmHg Interval -9.5 to -8.4	-9.0 mmHg Interval -9.6 to -8.4

SECONDARY outcome

Timeframe: 12 months after intervention period

Population: Includes only participants with an A1c in the 12 months after the intervention period.

Outcome measures

Measure	Pharmacist Management n=1477 Participants Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing) Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms	Usual Care n=1920 Participants Eligible patients receive usual care
A1c Control	7.4 percentage of total hemoglobin Standard Deviation 1.4	7.6 percentage of total hemoglobin Standard Deviation 1.6

SECONDARY outcome

Timeframe: 12 months after invention period

Population: Includes only participants with a LDL in the 12 months after the intervention period.

Outcome measures

Measure	Pharmacist Management n=1410 Participants Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing) Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms	Usual Care n=1824 Participants Eligible patients receive usual care
LDL Control	89.1 mg/dl Standard Deviation 31.1	87.8 mg/dl Standard Deviation 32.9

Adverse Events

Pharmacist Management

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. Michele Heisler

VA Center for Clinical Management Research; University of Michigan

Phone: 734-845-3504

Email: mheisler@umich.edu

Results disclosure agreements

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