An interrupted time series study of electronic health record clinical decision support for providers caring for patients with atrial fibrillation at increased stroke risk.

PURPOSE: To measure the effect of clinical decision support (CDS) on anticoagulation rates in patients with atrial fibrillation (AFib) or atrial flutter (AFlut) at high stroke risk and receiving care in outpatient settings, and to assess provider response to CDS. METHODS: This observational, quasi-experimental, interrupted time series study utilized electronic health record data at a large integrated delivery network in Texas from April to November 2020. CDS consisted of an electronic Best Practice Advisory (BPA)/alert (Epic Systems Corporation, Verona, WI) with links to 2 AFib order sets displayed to providers in outpatient settings caring for non-anticoagulated patients with AFib and elevated CHA2DS2VASc scores. Weekly outpatient anticoagulation rates were assessed in patients with high stroke risk before and after implementation of CDS. Alert actions and acknowledgment reasons were evaluated descriptively. RESULTS: Mean (SD) weekly counts of eligible patients were 8,917 (566) before and 8,881 (811) after implementation. Weekly anticoagulation rates increased during the pre-BPA study period (ß1 = 0.07%; SE, 0.02%; P = 0.0062); however, there were no significant changes in the level (ß2 = 0.60%; SE, 0.42%; P = 0.1651) or trend (ß3 = -0.01%; SE, 0.05%; P = 0.8256) of anticoagulation rates associated with CDS implementation. In encounters with the BPA/alert displayed (n = 17,654), acknowledgment reasons were provided in 4,473 (25.3%) of the encounters, with prescribers most commonly citing bleeding risk (n = 1,327, 7.5%) and fall risk (n = 855, 4.8%). CONCLUSION: There was a significant trend of increasing anticoagulation rates during the pre-BPA period, with no significant change in trend during the post-BPA period relative to the pre-BPA period.

Antihypertensive agent utilization patterns among patients with uncontrolled hypertension in the United States.

Hypertension affects approximately one-third of the US adults. This study investigated antihypertensive utilization patterns among hypertensive patients who were prescribed treatment, yet still experienced uncontrolled hypertension. Data from the Decision Resources Group Real World Evidence Data Repository US database (2015-2016) were used to construct a cohort of uncontrolled hypertension patients to observe antihypertensive utilization patterns. Results for 5059 patients, with an average age of 57.8 (SD = 13.7), who had, on average 2.4 agents prescribed. Approximately half (51.9%) were female, and most were White (86.8%). More than one-third (N = 1877; 37.1%) of patients were diagnosed with diabetes mellitus (DM) or chronic kidney disease (CKD) that could independently contribute to increased cardiovascular complications. Overall, the most common treatments prescribed, as percent of agents and as percent of patients, respectively, were diuretics (24.9%; 59.6%), followed by angiotensin-converting enzyme inhibitors (ACEIs) (23.8%; 56.9%), beta-blockers (BBs) (18.7%; 44.8%), calcium channel blockers (CCBs) (15.4%; 36.8%), and angiotensin II receptor blockers (ARBs) (13.5%; 32.3%). Approximately one-tenth (10.5%) of the prescriptions were written for fixed-dose combination therapies. Among patients diagnosed with DM and CKD (N = 200), the order of the most common agents was the same as the overall cohort. Only 5.6% of prescriptions written for these patients were fixed-dose combination therapy. Based on clinical guidelines, which suggest using ACEIs, ARBs, or CCBs as first-line therapy, and fixed-dose combination therapy to increase adherence, this indicates over-prescribing of BBs and under-prescribing of fixed-dose combination therapy. These findings illustrate the need to further investigate challenges faced by patients and providers in treatment decision-making.

Impact of Physician-Pharmacist Covisits at a Primary Care Clinic in Patients With Uncontrolled Diabetes.

PURPOSE: A popular method for enhancing medication management within a patient-centered medical home (PCMH) is the physician-pharmacist collaborative management (PPCM) model. To improve efficiency of health-care delivery within 4 federally qualified health centers (FQHCs), the PPCM model was implemented through coordinated physician-pharmacist covisits. OBJECTIVE: To evaluate the impact of physician-pharmacist covisits on clinical outcomes among patients with uncontrolled diabetes. METHODOLOGY: This was a retrospective multicenter cohort study including adults (≥18 years old) with uncontrolled type 1 or type 2 diabetes (hemoglobin A1c [HbA1c] ≥ 8 %) who had at least one covisit between January 1, 2013, and October 1, 2016. The primary clinical metric was mean change in HbA1c from baseline to follow-up. Secondary outcomes included adherence to select American Diabetes Association (ADA) Standards of Medical Care. RESULTS: A total of 106 patients were included in this analysis. Patients who were managed in the PPCM model experienced a significant decrease in mean change in HbA1c from baseline to follow-up (-1.75 [2.63], P < .001). There was no significant difference in the proportion of patients receiving recommended vaccinations or cardiovascular (CV) risk reduction medications. CONCLUSION: The results suggest that physician-pharmacist covisits may improve glucose control in patients with uncontrolled diabetes.

Association of Total Medication Burden With Intensive and Standard Blood Pressure Control and Clinical Outcomes: A Secondary Analysis of SPRINT.

Total medication burden (antihypertensive and nonantihypertensive medications) may be associated with poor systolic blood pressure (SBP) control. We investigated the association of baseline medication burden and clinical outcomes and whether the effect of the SBP intervention varied according to baseline medication burden in SPRINT (Systolic Blood Pressure Intervention Trial). Participants were randomized to intensive or standard SBP goal (below 120 or 140 mm Hg, respectively); n=3769 participants with high baseline medication burden (≥5 medications) and n=5592 with low burden (<5 medications). PRIMARY OUTCOME: differences in SBP. SECONDARY OUTCOMES: 8-item Morisky Medication Adherence Scale and modified Treatment Satisfaction Questionnaire for Medications measured at baseline and 12 months and incident cardiovascular disease events and serious adverse events throughout the trial. Participants in the intensive group with high versus low medication burden were less likely to achieve their SBP goal at 12 months (risk ratio, 0.91; 95% CI, 0.85-0.97) but not in the standard group (risk ratio, 0.98; 95% CI, 0.93-1.03; Pinteraction<0.001). High medication burden was associated with increased cardiovascular disease events (hazard ratio, 1.39; 95% CI, 1.14-1.70) and serious adverse events (hazard ratio, 1.34; 95% CI, 1.24-1.45), but the effect of intensive versus standard treatment did not vary between medication burden groups (Pinteraction>0.5). Medication burden had minimal association with adherence or satisfaction. High baseline medication burden was associated with worse intensive SBP control and higher rates of cardiovascular disease events and serious adverse events. The relative benefits and risks of intensive SBP goals were similar regardless of medication burden. CLINICAL TRIAL REGISTRATION- URL: http://www. CLINICALTRIALS: gov. Unique identifier: NCT01206062.

Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease.

OBJECTIVES: The objectives of this study were to determine if hypertensive patients with comorbid diabetes mellitus (DM) and/or chronic kidney disease (CKD) receiving a pharmacist intervention had a greater reduction in mean blood pressure (BP) and improved BP control at 9 months compared with those receiving usual care; and compare Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guideline and 2014 guideline (JNC 8) BP control rates in patients with DM and/or CKD. METHODS: This cluster randomized trial included 32 medical offices in 15 states. Clinical pharmacists made treatment recommendations to physicians at intervention sites. This post hoc analysis evaluated mean BP and BP control rates in the intervention and control groups. MAIN RESULTS: The study included 335 patients (227 intervention, 108 control) when mean BP and control rates were evaluated by JNC 7 inclusion and control criteria. When JNC 8 inclusion and control criteria were applied, 241 patients (165 intervention, 76 control) remained and were included in the analysis. The pharmacist-intervention group had significantly greater mean systolic blood pressure reduction compared with usual care at 9 months (8.64 mm Hg; 95% confidence interval [CI] -12.8 to -4.49, p<0.001). The pharmacist-intervention group had significantly higher BP control at 9 months than usual care by either the JNC 7 or JNC 8 inclusion and control groups (adjusted odds ratio [OR] 1.97, 95% CI 1.01-3.86, p=0.0470 and OR 2.16, 95% CI 1.21-3.85, p=0.0102, respectively). PRINCIPAL CONCLUSIONS: This study demonstrated that a physician-pharmacist collaborative intervention was effective in reducing mean systolic BP and improving BP control in patients with uncontrolled hypertension with DM and/or CKD, regardless of which BP guidelines were used.

The benefits of physician-pharmacist collaboration.

Over the past decade, physician-pharmacist collaborative practices have gained traction in primary care as a way to implement team-based-care models. And there is evidence pointing to the effectiveness of this multidisciplinary heath care team approach, in which pharmacists are typically responsible for such things as obtaining medication histories, identifying barriers to adherence, and adjusting medication regimens. Several studies have shown the significant impact that physician-pharmacist collaborative management (PPCM) can have on blood pressure control among patients with hypertension. Additionally, PPCM may have positive effects on HbA1c reduction and diabetes control, suggesting that benefits may extend to other chronic diseases, too.

Selection bias and subject refusal in a cluster-randomized controlled trial.

BACKGROUND: Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. METHODS: The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE) study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site's allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. RESULTS: There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1.92). CONCLUSIONS: Though there appeared to be a higher consent rate for females than for males, the overall impact of potential selection bias and refusal to participate was minimal. Without rigorous methodology, selection bias may be a threat to external validity in cluster-randomized trials. TRIAL REGISTRATION: NCT01983813 . Date of registration: Oct. 28, 2013.

Physician-Pharmacist Collaborative Management: Narrowing the Socioeconomic Blood Pressure Gap.

Physician-pharmacist collaboration improves blood pressure, but there is little information on whether this model can reduce the gap in healthcare disparities. This trial involved 32 medical offices in 15 states. A clinical pharmacist was embedded within each office and made recommendations to physicians and patients in intervention offices. The purpose of the present analysis was to evaluate whether the pharmacist intervention could reduce healthcare disparities by improving blood pressure in high-risk racial and socioeconomic subjects compared with the control group. The analyses in minority subjects were prespecified secondary analyses, but all other comparisons were secondary, post hoc analyses. The 9-month visit was completed by 539 patients: 345 received the intervention, and 194 were in the control group. Following the intervention, mean systolic blood pressure was found to be 7.3 mm Hg (95% confidence interval 2.4, 12.3) lower in subjects from racial minority groups who received the intervention compared with the control group (P=0.0042). Subjects with ≤12 years of education in the intervention group had a systolic blood pressure 8.1 mm Hg (95% confidence interval 3.2, 13.1) lower than the control group with lower education (P=0.0001). Similar reductions in blood pressure occurred in patients with low incomes, those receiving Medicaid, or those without insurance. This study demonstrated that a pharmacist intervention reduced racial and socioeconomic disparities in the treatment of blood pressure. Although disparities in blood pressure were reduced by the intervention, there were still nonsignificant gaps in mean systolic blood pressure when compared with intervention subjects not at risk. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00935077.

Physician-pharmacist collaboration versus usual care for treatment-resistant hypertension.

Team-based care has been recommended for patients with treatment-resistant hypertension (TRH), but its efficacy in this setting is unknown. We compared a physician-pharmacist collaborative model (PPCM) to usual care in patients with TRH participating in the Collaboration Among Pharmacists and Physicians To Improve Outcomes Now study. At baseline, 169 patients (27% of Collaboration Among Pharmacists and Physicians To Improve Outcomes Now patients) had TRH: 111 received the PPCM intervention and 58 received usual care. Baseline characteristics were similar between treatment arms. After 9 months, adjusted mean systolic blood pressure was reduced by 7 mm Hg more with PPCM intervention than usual care (P = .036). Blood pressure control was 34.2% with PPCM versus 25.9% with usual care (adjusted odds ratio, 1.92; 95% confidence interval, 0.33-11.2). These findings suggest that team-based care in the primary care setting may be effective for TRH. Additional research is needed regarding the long-term impact of these models and to identify patients most likely to benefit from team-based interventions.

Cluster randomized trials for pharmacy practice research.

Introduction Cluster randomized trials (CRTs) are now the gold standard in health services research, including pharmacy-based interventions. Studies of behaviour, epidemiology, lifestyle modifications, educational programs, and health care models are utilizing the strengths of cluster randomized analyses. Methodology The key property of CRTs is the unit of randomization (clusters), which may be different from the unit of analysis (individual). Subject sample size and, ideally, the number of clusters is determined by the relationship of between-cluster and within-cluster variability. The correlation among participants recruited from the same cluster is known as the intraclass correlation coefficient (ICC). Generally, having more clusters with smaller ICC values will lead to smaller sample sizes. When selecting clusters, stratification before randomization may be useful in decreasing imbalances between study arms. Participant recruitment methods can differ from other types of randomized trials, as blinding a behavioural intervention cannot always be done. When to use CRTs can yield results that are relevant for making "real world" decisions. CRTs are often used in non-therapeutic intervention studies (e.g. change in practice guidelines). The advantages of CRT design in pharmacy research have been avoiding contamination and the generalizability of the results. A large CRT that studied physician-pharmacist collaborative management of hypertension is used in this manuscript as a CRT example. The trial, entitled Collaboration Among Pharmacists and physicians To Improve Outcomes Now (CAPTION), was implemented in primary care offices in the United States for hypertensive patients. Limitations CRT design limitations include the need for a large number of clusters, high costs, increased training, increased monitoring, and statistical complexity.

A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence.

BACKGROUND: Numerous studies have demonstrated the value of including pharmacists in team-based care to improve adherence to cardiovascular (CV) guidelines, medication adherence, and risk factor control. However, there is limited information on whether these models can be successfully implemented more widely in diverse settings and populations. The purpose of this study is to evaluate whether a centralized, web-based cardiovascular risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics. METHODS: This study is a prospective trial in 20 primary care offices stratified by the percent of under-represented minorities and then randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. The primary outcome is the difference in guideline adherence between groups. Data will also be abstracted from the medical record at 24 months to determine if the intervention effect is sustained after it is discontinued. CONCLUSIONS: Patient enrollment will continue through 2016, with results expected in 2019. This study will provide information on whether a distant, centralized CVRS can be implemented in large numbers of medical offices, if it is effective in diverse populations, and if there is a long-term sustained effect.

Pharmacist intervention for blood pressure control: medication intensification and adherence.

The objective of this study was to describe medication adherence and medication intensification in a physician-pharmacist collaborative management (PPCM) model compared with usual care. This study was a prospective, cluster, randomized study in 32 primary care offices from 15 states. The primary outcomes were medication adherence and anti-hypertensive medication changes during the first 9 months of the intervention. The 9-month visit was completed by 539 patients, 345 of which received the intervention. There was no significant difference between intervention and usual care patients in regards to medication adherence at 9 months. Intervention patients received significantly more medication changes (4.9 vs.1.1; P = .0003) and had significantly increased use of diuretics and aldosterone antagonists when compared with usual care (P = .01).The PPCM model increased medication intensification; however, no significant change in medication adherence was detected. PPCM models will need to develop non-adherence identification and intervention methods to further improve the potency of the care team.

A centralized cardiovascular risk service to improve guideline adherence in private primary care offices.

BACKGROUND: Many large health systems now employ clinical pharmacists in team-based care to assist patients and physicians with management of cardiovascular (CV) diseases. However, small private offices often lack the resources to hire a clinical pharmacist for their office. The purpose of this study is to evaluate whether a centralized, web-based CV risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in primary care medical offices in rural and small communities. METHODS: This study is a cluster randomized prospective trial in 12 primary care offices. Medical offices were randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. Primary outcomes will include adherence to treatment guidelines and control of key CV risk factors. Data will also be abstracted from the medical record at 30 months to determine if the intervention effect is sustained after it is discontinued. CONCLUSIONS: This study will enroll subjects through 2015 and results will be available in 2018. This study will provide information on whether a distant, centralized CV risk service can improve guideline adherence in medical offices that lack the resources to employ clinical pharmacists.

Physician-pharmacist collaborative management of asthma in primary care.

OBJECTIVE: To determine if asthma control improves in patients who receive physician-pharmacist collaborative management (PPCM) during visits to primary care medical offices. DESIGN: Prospective pre-post study of patients who received the intervention in primary care offices for 9 months. The primary outcome was the sum of asthma-related emergency department (ED) visits and hospitalizations at 9 months before, 9 months during, and 9 months after the intervention. Events were analyzed using linear mixed-effects regression. Secondary analysis was conducted for patients with uncontrolled asthma (Asthma Control Test [ACT] less than 20). Additional secondary outcomes included the ACT, the Asthma Quality of Life Questionnaire by Marks (AQLQ-M) scores, and medication changes. INTERVENTION: Pharmacists provided patients with an asthma self-management plan and education and made pharmacotherapy recommendations to physicians when appropriate. RESULTS: Of 126 patients, the number of emergency department (ED) visits and/or hospitalizations decreased 30% during the intervention (p=0.052) and then returned to preenrollment levels after the intervention was discontinued (p=0.83). Secondary analysis of patients with uncontrolled asthma at baseline (ACT less than 20), showed 37 ED visits and hospitalizations before the intervention, 21 during the intervention, and 33 after the intervention was discontinued (p=0.019). ACT and AQLQ-M scores improved during the intervention (ACT mean absolute increase of 2.11, AQLQ-M mean absolute decrease of 4.86, p<0.0001) and sustained a stable effect after discontinuation of the intervention. Inhaled corticosteroid use increased during the intervention (p=0.024). CONCLUSIONS: The PPCM care model reduced asthma-related ED visits and hospitalizations and improved asthma control and quality of life. However, the primary outcome was not statistically significant for all patients. There was a significant reduction in ED visits and hospitalizations during the intervention for patients with uncontrolled asthma at baseline. Our findings support the need for further studies to investigate asthma outcomes achievable with the PPCM model.

Outcomes of Individualized Formative Assessments in a Pharmacy Skills Laboratory.

OBJECTIVE: To determine the effectiveness of an individualized teaching method in a pharmacy skills laboratory. DESIGN: All third-year students enrolled in an Accreditation Council for Pharmacy Education (ACPE) accredited doctor of pharmacy program (n=150) received an individual formative assessment from clinical pharmacists on communication skills and clinical competency after the students counseled standardized mock glaucoma patients during a laboratory focused on alternative dosing formulations. Objective structured clinical examination (OSCE) scores for this station from the 2012 and 2013 classes were compared before and after the intervention. ASSESSMENT: Ophthalmic OSCE station scores were higher after the individual formative feedback intervention. Students in 2013 had a mean score of 83.2 ± 8.3% compared to a mean of 74.3 ± 12.9% in 2012 for this OSCE station. The percentage of students receiving an "A" on the OSCE station increased from 8.1% to 31.3% after the intervention. CONCLUSION: Individualized formative teaching methods benefited students in both their communication skills and clinical assessment. Future research should focus on wider implementation and overcoming obstacles, such as increased facilitator needs.