Browsing by Author "Klamerus, Mandi L"
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Item Open Access Characteristics of diabetic patients associated with achieving and maintaining blood pressure targets in the Adherence and Intensification of Medications program.(Chronic illness, 2014-03) Klamerus, Mandi L; Kerr, Eve A; Bosworth, Hayden B; Schmittdiel, Julie A; Heisler, MicheleObjectives
To determine patient characteristics associated with achieving and sustaining blood pressure (BP) targets in the Adherence and Intensification of Medications program, a program led by pharmacists trained in motivational interviewing and authorized to make BP medication changes.Methods
We conducted a retrospective cohort study of patients with diabetes and persistent hypertension in Kaiser Permanente and the Department of Veterans Affairs. Using two-level logistic regression, baseline survey data from 458 program participants were examined to determine patient characteristics associated with (1) discharge from the program with a target BP (short-term success) and (2) maintenance of the target BP over a nine-month period (long-term success).Results
In multivariable analyses, patients who screened positive for depression or had a higher baseline systolic BP were less likely to achieve short-term success (adjusted odds ratio (AOR) 0.42 [95% confidence interval (CI): 0.19-0.93], p = 0.03; AOR 0.94 [0.91-0.97], p < 0.01; respectively). Patients who reported at baseline one or more barriers to medication adherence were less likely to achieve long-term success (AOR 0.50 [0.26-0.94], p = 0.03).Conclusions
Although almost 90% of patients achieved short-term success, only 28% achieved long-term success. Baseline barriers to adherence were associated with lack of long-term success and could be the target of maintenance programs for patients who achieve short-term success.Item Open Access Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control.(Chronic illness, 2014-12) Crowley, Matthew J; Holleman, Rob; Klamerus, Mandi L; Bosworth, Hayden B; Edelman, David; Heisler, MicheleObjectives
Patients with persistent poorly controlled diabetes mellitus (PPDM), defined as an uninterrupted hemoglobin A1c >8.0% for ≥1 year despite standard care, are at high risk for complications. Additional research to define patient factors associated with PPDM could suggest barriers to improvement in this group and inform the development of targeted strategies to address these patients' resistant diabetes.Methods
We analyzed patients with type 2 diabetes from a multi-site randomized trial. We characterized patients with PPDM relative to other patients using detailed survey data and multivariable modeling.Results
Of 963 patients, 118 (12%) had PPDM, 265 (28%) were intermittently poorly controlled, and 580 (60%) were well-controlled. Patients with PPDM had younger age, earlier diabetes diagnosis, insulin use, higher antihypertensive burden, higher low-density lipoprotein cholesterol, and lower statin use relative to well-controlled patients. Among patients with objective adherence data (Veterans Affairs patients), a larger oral diabetes medication refill gap was associated with PPDM.Discussion
Strategies are needed to target-specific barriers to improvement among patients whose diabetes is resistant to standard diabetes care. Our data suggest that strategies for targeting PPDM should accommodate younger patients' lifestyles, include medication management for insulin titration and comorbid disease conditions, and address barriers to self-management adherence.Item Open Access 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, 2012-06) Heisler, Michele; Hofer, Timothy P; Schmittdiel, Julie A; Selby, Joe V; Klamerus, Mandi L; Bosworth, Hayden B; Bermann, Martin; Kerr, Eve ABackground
Even in high-performing health systems, some patients with diabetes mellitus have poor blood pressure (BP) control because of poor medication adherence and lack of medication intensification. We examined whether the Adherence and Intensification of Medications intervention, a pharmacist-led intervention combining elements found in efficacy studies to lower BP, improved BP among patients with diabetes mellitus with persistent hypertension and poor refill adherence or insufficient medication intensification in 2 high-performing health systems.Methods and results
We conducted a prospective, multisite cluster randomized pragmatic trial with randomization of 16 primary care teams at 5 medical centers (3 Veterans Affairs and 2 Kaiser Permanente) to the Adherence and Intensification of Medications intervention or usual care. The primary outcome was relative change in systolic BP (SBP), comparing 1797 intervention with 2303 control team patients, from 6 months preceding to 6 months after the 14-month intervention period. We examined shorter-term changes in SBP as a secondary outcome. The mean SBP decrease from 6 months before to 6 months after the intervention period was ≈9 mm Hg in both arms. Mean SBPs of eligible intervention patients were 2.4 mm Hg lower (95% CI: -3.4 to -1.5; P<0.001) immediately after the intervention than those achieved by control patients.Conclusions
The Adherence and Intensification of Medications program more rapidly lowered SBPs among intervention patients, but usual-care patients achieved equally low SBP levels by 6 months after the intervention period. These findings show the importance of evaluating in different real-life clinical settings programs found in efficacy trials to be effective before urging their widespread adoption in all settings.Clinical trial registration
URL: http://clinicaltrials.gov. Unique identifier: NCT00495794.Item Open Access Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.(Trials, 2010-10-12) Heisler, Michele; Hofer, Timothy P; Klamerus, Mandi L; Schmittdiel, Julie; Selby, Joe; Hogan, Mary M; Bosworth, Hayden B; Tremblay, Adam; Kerr, Eve ABACKGROUND: 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.