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Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

Heisler M, Hofer TP, Klamerus ML, Schmittdiel J, Selby J, Hogan MM, Bosworth HB, Tremblay A, Kerr EA - Trials (2010)

Bottom Line: Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications.Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen.Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care.

View Article: PubMed Central - HTML - PubMed

Affiliation: Veterans Affairs Center for Clinical Management Research, VA Ann Arbor Healthcare System 2215 Fuller Road, Ann Arbor, MI 48105, USA. mheisler@umich.edu

ABSTRACT

Background: Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen.

Methods: In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates.

Discussion: Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care.

Trial registration: The ClinicalTrials.gov registration number is NCT00495794.

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Intervention Logic Model.
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Figure 2: Intervention Logic Model.

Mentions: The pathways by which we hypothesize our intervention elements will affect outcomes are illustrated in Figure 2. A key theory underpinning our intervention is Self Determination Theory (SDT)[34-36] a theory that suggests that effective interventions need to encourage patients to articulate their own values and goals (autonomy), be convinced that recommended behaviors correspond with these intrinsic values and goals (autonomous motivation), and have confidence in their ability to execute the targeted behaviors (competence). Another congruent behavioral theory informing our intervention is social cognitive theory (SCT) [37,38]. SCT also builds on the importance of understanding the personal salience of a health risk and of developing intrinsic motivation to change behaviors. It further emphasizes the importance of patients' confidence (or self-efficacy) in their ability to execute specific tasks. Self-efficacy has been shown to improve physiologic outcomes and functioning,[39] and SCT theory has underpinned many of the most successful chronic disease self-management support programs evaluated to date [40,41]. The clinical pharmacists were thus trained in Motivational Interviewing (MI)-based approaches that emphasize the fostering of patients' autonomous motivation and self-efficacy to execute successfully their diabetes medication and other self-care tasks.


Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

Heisler M, Hofer TP, Klamerus ML, Schmittdiel J, Selby J, Hogan MM, Bosworth HB, Tremblay A, Kerr EA - Trials (2010)

Intervention Logic Model.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2967508&req=5

Figure 2: Intervention Logic Model.
Mentions: The pathways by which we hypothesize our intervention elements will affect outcomes are illustrated in Figure 2. A key theory underpinning our intervention is Self Determination Theory (SDT)[34-36] a theory that suggests that effective interventions need to encourage patients to articulate their own values and goals (autonomy), be convinced that recommended behaviors correspond with these intrinsic values and goals (autonomous motivation), and have confidence in their ability to execute the targeted behaviors (competence). Another congruent behavioral theory informing our intervention is social cognitive theory (SCT) [37,38]. SCT also builds on the importance of understanding the personal salience of a health risk and of developing intrinsic motivation to change behaviors. It further emphasizes the importance of patients' confidence (or self-efficacy) in their ability to execute specific tasks. Self-efficacy has been shown to improve physiologic outcomes and functioning,[39] and SCT theory has underpinned many of the most successful chronic disease self-management support programs evaluated to date [40,41]. The clinical pharmacists were thus trained in Motivational Interviewing (MI)-based approaches that emphasize the fostering of patients' autonomous motivation and self-efficacy to execute successfully their diabetes medication and other self-care tasks.

Bottom Line: Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications.Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen.Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care.

View Article: PubMed Central - HTML - PubMed

Affiliation: Veterans Affairs Center for Clinical Management Research, VA Ann Arbor Healthcare System 2215 Fuller Road, Ann Arbor, MI 48105, USA. mheisler@umich.edu

ABSTRACT

Background: Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen.

Methods: In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates.

Discussion: Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care.

Trial registration: The ClinicalTrials.gov registration number is NCT00495794.

Show MeSH
Related in: MedlinePlus