Adherence and Intensification of Medications (AIM) Implementation Study

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00495794
First received: June 29, 2007
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: September 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Hypertension
Intervention: Behavioral: Clinical pharmacist-based intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Pharmacist Management     Usual Care  
STARTED     2319     2303  
COMPLETED     1797     2303  
NOT COMPLETED     522     0  
Pharmacist did not activate patient                 522                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Pharmacist Management     Usual Care     Total  
Number of Participants  
[units: participants]
  1797     2303     4100  
Age  
[units: years]
Mean ± Standard Deviation
  65.3  ± 11.7     65.3  ± 12.1     65.3  ± 11.9  
Gender  
[units: participants]
     
Female     547     721     1268  
Male     1250     1582     2832  
Region of Enrollment  
[units: participants]
     
United States     1797     2303     4100  



  Outcome Measures
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1.  Primary:   Change in Systolic Blood Pressure   [ Time Frame: 6 months prior to 6 months after the intervention period ]

2.  Secondary:   A1c Control   [ Time Frame: 12 months after intervention period ]

3.  Secondary:   LDL Control   [ Time Frame: 12 months after invention period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In the intervention arm, only 53% of subjects had a pharmacist encounter. Higher rates of participation might have led to a more substantial initial improvement and a detectable longer term effect.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michele Heisler
Organization: VA Center for Clinical Management Research; University of Michigan
phone: 734-845-3504
e-mail: mheisler@umich.edu


Publications of Results:


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00495794     History of Changes
Other Study ID Numbers: SDP 06-128, R18DK076622-01
Study First Received: June 29, 2007
Results First Received: September 3, 2014
Last Updated: September 10, 2014
Health Authority: United States: Federal Government