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Adherence and Intensification of Medications (AIM) Implementation Study

NCT00495794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4622

Last updated 2015-04-28

Study results available
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Summary

Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control.

Objectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.

Conditions

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Kaiser Permanente

    collaborator OTHER

  • US Department of Veterans Affairs

    lead FED

Principal Investigators

  • M. E. Michele Heisler, MD MPA · VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-03-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495794 on ClinicalTrials.gov