Adherence and Intensification of Medications (AIM) Implementation Study

This study has been completed.

Sponsor:

Collaborators:

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

Kaiser Permanente

Information provided by (Responsible Party):

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00495794

First received: June 29, 2007

Last updated: April 6, 2015

Last verified: July 2014

History of Changes

Results First Received: September 3, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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.
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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

Description

Pharmacist Management

Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)

Usual Care

Eligible patients receive usual care

Total

Total of all reporting groups

Baseline Measures

	Pharmacist Management	Usual Care	Total
Overall Participants Analyzed [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 ]

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2. Secondary:

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

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3. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

Heisler M, Hofer TP, Klamerus ML, Schmittdiel J, Selby J, Hogan MM, Bosworth HB, Tremblay A, Kerr EA. Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study. Trials. 2010 Oct 12;11:95. doi: 10.1186/1745-6215-11-95.

Klamerus ML, Kerr EA, Bosworth HB, Schmittdiel JA, Heisler M. Characteristics of diabetic patients associated with achieving and maintaining blood pressure targets in the Adherence and Intensification of Medications program. Chronic Illn. 2014 Mar;10(1):60-73. doi: 10.1177/1742395313496590. Epub 2013 Jul 26.

Heisler M, Hofer TP, Schmittdiel JA, Selby JV, Klamerus ML, Bosworth HB, Bermann M, Kerr EA. Improving blood pressure control through a clinical pharmacist outreach program in patients with diabetes mellitus in 2 high-performing health systems: the adherence and intensification of medications cluster randomized, controlled pragmatic trial. Circulation. 2012 Jun 12;125(23):2863-72. doi: 10.1161/CIRCULATIONAHA.111.089169. Epub 2012 May 8.

Meddings J, Kerr EA, Heisler M, Hofer TP. Physician assessments of medication adherence and decisions to intensify medications for patients with uncontrolled blood pressure: still no better than a coin toss. BMC Health Serv Res. 2012 Aug 21;12:270. doi: 10.1186/1472-6963-12-270.

Sussman JB, Zulman DM, Hayward R, Hofer TP, Kerr EA. Cardiac risk is not associated with hypertension treatment intensification. Am J Manag Care. 2012 Aug;18(8):414-20.

Selby JV, Schmittdiel JA, Fireman B, Jaffe M, Ransom LJ, Dyer W, Uratsu CS, Reed ME, Kerr EA, Hsu J. Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial. BMC Health Serv Res. 2012 Jul 2;12:183. doi: 10.1186/1472-6963-12-183.

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00495794 History of Changes
Other Study ID Numbers:	SDP 06-128 R18DK076622-01 ( U.S. NIH Grant/Contract )
Study First Received:	June 29, 2007
Results First Received:	September 3, 2014
Last Updated:	April 6, 2015

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