Browsing by Subject "Pharmacists"
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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 Lessons learned from two randomized controlled trials: CITIES and STOP-DKD.(Contemporary clinical trials communications, 2020-09) Zullig, Leah L; Oakes, Megan M; McCant, Felicia; Bosworth, Hayden BBackground
Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings.Objectives
Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials.Methods
These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina.Conclusions
We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens.Trial registration
Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.Item Open Access Patient-reported medication adherence barriers among patients with cardiovascular risk factors.(Journal of managed care & specialty pharmacy, 2015-06) Zullig, Leah L; Stechuchak, Karen M; Goldstein, Karen M; Olsen, Maren K; McCant, Felicia M; Danus, Susanne; Crowley, Matthew J; Oddone, Eugene Z; Bosworth, Hayden BBackground
Many patients experience barriers that make it difficult to take cardiovascular disease (CVD)-related medications as prescribed. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES) was a tailored behavioral pharmacist-administered and telephone-based intervention for reducing CVD risk.Objectives
To (a) describe patient-reported barriers to taking their medication as prescribed and (b) evaluate patient-level characteristics associated with reporting medication barriers.Methods
We recruited patients receiving care at primary care clinics affiliated with Durham Veterans Affairs Medical Center. Eligible patients were diagnosed with hypertension and/or hyperlipidemia that were poorly controlled (blood pressure of > 150/100 mmHg and/or low-density lipoprotein value > 130 mg/dL). At the time of enrollment, patients completed an interview with 7 questions derived from a validated medication barriers measure. Patient characteristics and individual medication treatment barriers are described. Multivariable linear regression was used to examine the association between a medication barrier score and patient characteristics.Results
Most patients (n = 428) were married or living with their partners (57%) and were men (85%) who were diagnosed with hypertension and hyperlipidemia (64%). The most commonly reported barriers were having too much medication to take (31%) and forgetting whether medication was taken at a particular time (24%). In adjusted analysis, those who were not employed (1.32, 95% CI = 0.50-2.14) or did not have someone to help with tasks, if needed (1.66, 95% CI = 0.42-2.89), reported higher medication barrier scores. Compared with those diagnosed with hypertension and hyperlipidemia, those with only hypertension (0.91, 95% CI = 0.04-1.79) reported higher medication barrier scores.Conclusions
Barriers to medication adherence are common. Evaluating and addressing barriers may increase medication adherence.Item Open Access Pharmacy-based methadone treatment in the US: views of pharmacists and opioid treatment program staff.(Substance abuse treatment, prevention, and policy, 2023-09) Wu, Li-Tzy; Mannelli, Paolo; John, William S; Anderson, Alyssa; Schwartz, Robert PBackground
The US federal regulations allow pharmacy administration and dispensing of methadone for opioid use disorder (PADMOUD) to increase the capability of opioid treatment programs (OTPs) in providing methadone maintenance treatment (MMT) for opioid use disorder (OUD) as part of a medication unit. However, there is a lack of research data from both pharmacy and OTP staff to inform the implementation of PADMOUD.Methods
Staff of a pharmacy (n = 8) and an OTP (n = 9) that participated in the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were recruited to participate in this qualitative interview study to explore implementation-related factors for PADMOUD. Each interview was recorded and transcribed verbatim. NVivo was used to help identify themes of qualitative interview data. The Promoting Action on Research Implementation in Health Services (PARIHS) framework was used to guide the coding and interpretation of data.Results
Six pharmacy staff and eight OTP staff (n = 14) completed the interview. Results based on PARIHS domains were summarized, including evidence, context, and facilitation domains. Participants perceived benefits of PADMOUD for patients, pharmacies, OTPs, and payers. PADMOUD was considered to increase access for stable patients, provide additional patient service opportunities and revenues for pharmacies/pharmacists, enhance the capability of OTPs to treat more new patients, and reduce patients' cost when receiving medication at a pharmacy relative to an OTP. Both pharmacy and OTP staff were perceived to be supportive of the implementation of PADMOUD. Pharmacy staff/pharmacists were perceived to need proper training on addiction and methadone as well as a protocol of PADMOUD to conduct PADMOUD. Facilitators include having thought leaders to guide the operation, a certification program to ensure proper training of pharmacy staff/pharmacist, having updated pharmacy service software or technology to streamline the workflow of delivering PADMOUD and inventory management, and reimbursement for pharmacists.Conclusion
This study presents the first findings on perspectives of PADMOUD from both staff of a community pharmacy and an OTP in the US. Finding on barriers and facilitators are useful data to guide the development of strategies to implement PADMOUD to help address the US opioid crisis.Item Open Access Primary Care Providers' Acceptance of Pharmacists' Recommendations to Support Optimal Medication Management for Patients with Diabetic Kidney Disease.(Journal of general internal medicine, 2020-01) Zullig, Leah L; Jazowski, Shelley A; Davenport, Clemontina A; Diamantidis, Clarissa J; Oakes, Megan M; Patel, Sejal; Moaddeb, Jivan; Bosworth, Hayden BBackground
Patients with diabetic kidney disease (DKD) often struggle with blood pressure control. In team-based models of care, pharmacists and primary care providers (PCPs) play important roles in supporting patients' blood pressure management.Objective
To describe whether PCPs' acceptance of pharmacists' recommendations impacts systolic blood pressure (SBP) at 36 months.Design
An observational analysis of a subset of participants randomized to the intervention arm of the Simultaneous risk factor control using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study.Participants
STOP-DKD participants for whom (1) the pharmacist made at least one recommendation to the PCP; (2) there were available data regarding the PCP's corresponding action; and (3) there were SBP measurements at baseline and 36 months.Intervention
Participants received monthly telephone calls with a pharmacist addressing health behaviors and medication management. Pharmacists made medication-related recommendations to PCPs.Main measures
We fit an unadjusted generalized linear mixed model to assess the association between the number of pharmacists' recommendations for DKD and blood pressure management and PCPs' acceptance of such recommendations. We used a linear regression model to evaluate the association between PCP acceptance and SBP at 36 months, adjusted for baseline SBP.Key results
Pharmacists made 176 treatment recommendations (among 59 participants), of which 107 (61%) were accepted by PCPs. SBP significantly declined by an average of 10.5 mmHg (p < 0.01) among 47 of 59 participants who had valid measurements at baseline and 36 months. There was a significant association between the number of pharmacist recommendations and the odds of PCP acceptance (OR 1.19; 95%CI 1.00, 1.42; p < 0.05), but no association between the number of accepted recommendations and SBP.Conclusions
Pharmacists provided actionable medication-related recommendations. We identified a significant decline in SBP at 36 months, but this reduction was not associated with recommendation acceptance.Trial registration
NCT01829256.Item Open Access Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.(Medical care, 2020-11) Kobe, Elizabeth A; Diamantidis, Clarissa J; Bosworth, Hayden B; Davenport, Clemontina A; Oakes, Megan; Alexopoulos, Anastasia-Stefania; Pendergast, Jane; Patel, Uptal D; Crowley, Matthew JBackground
African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline.Objective
The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline.Research design
Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control.Measures
The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm.Results
Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).Conclusion
A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.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.Item Open Access Telemedicine cardiovascular risk reduction in veterans.(American heart journal, 2013-04) Melnyk, S Dee; Zullig, Leah L; McCant, Felicia; Danus, Susanne; Oddone, Eugene; Bastian, Lori; Olsen, Maren; Stechuchak, Karen M; Edelman, David; Rakley, Susan; Morey, Miriam; Bosworth, Hayden BBackground
Patients with co-occurrence of hypertension, hyperlipidemia, and diabetes have an increased risk of cardiovascular disease (CVD) events. Comprehensive programs addressing both tailored patient self-management and pharmacotherapy are needed to address barriers to optimal cardiovascular risk reduction. We are examining a Clinical pharmacy specialist-, telephone-administered intervention, relying on home monitoring, with a goal of providing tailored medication and behavioral intervention to Veterans with CVD risk.Methods
Randomized controlled trial including patients with hypertension (blood pressure >150/100 mm Hg) or elevated low density liporotein (>130 mg/dL). Longitudinal changes in CVD risk profile and improvement in health behaviors over time will be examined.Conclusion
Given the national prevalence of CVD and the dismal rates of risk factor control, intensive but easily disseminated interventions are required to treat this epidemic. This study will be an important step in testing the effectiveness of a behavioral and medication intervention to improve CVD control among Veterans.Item Open Access The hypertension team: the role of the pharmacist, nurse, and teamwork in hypertension therapy.(Journal of clinical hypertension (Greenwich, Conn.), 2012-01) Carter, Barry L; Bosworth, Hayden B; Green, Beverly BTeam-based care is one of the key components of the patient-centered medical home. Studies have consistently demonstrated that teams involving pharmacists or nurses in patient management can significantly improve blood pressure control. These findings have been demonstrated in several meta-analyses and systematic reviews. These reviews have generally found that team-based care can reduce systolic blood pressure by 4-10 mm Hg over usual care. However, these reviews have also concluded that many of the studies had various limitations and that additional research should be conducted. The present state of the art review paper will highlight newer studies, many of which were funded by the National Institutes of Health. Newer strategies involve telephone and/or web-based management which is an evolving area to improve blood pressure control in large populations. Social media and other technology is currently being investigated to assist pharmacists or nurses in communicating with patients to improve hypertension management. Few cost-effectiveness analyses have been performed but generally have found favorable costs for team-based care when considering the potential to reduce morbidity and mortality. The authors will suggest additional research that needs to be conducted to help evaluate strategies to best implement team-based care to improve blood pressure management.