Lisa B. Cohen

Pharmacist-Led Shared Medical Appointments for Multiple Cardiovascular Risk Reduction in Patients With Type 2 Diabetes:

Purpose To assess whether VA MEDIC-E (Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction[EM DASH] Extended for 6 months), a pharmacist-led shared medical appointments program, could improve attainment of target goals for hypertension, hyperglycemia, hyperlipidemia, and tobacco use in patients with type 2 diabetes compared to standard primary care after 6 months of intervention. Methods A randomized, controlled trial of VA MEDIC-E (n = 50) versus standard primary care (n = 49) in veterans with type 2 diabetes, hemoglobin A1c (A1C) > 7%, blood pressure (BP) > 130/80 mmHg, and low density lipoprotein cholesterol (LDL-C) > 100mg/dl (2.59 mmol/l) in the previous 6 months was conducted. The VA MEDIC-E intervention consisted of 4 weekly group sessions followed by 5 monthly booster group sessions. Each 2-hour session included 1 hour of multidisciplinary diabetes specific healthy lifestyle education and 1 hour of pharmacotherapeutic interventions performed by a clinical pharmacist. Evaluation measures included lab values of A1C, LDL cholesterol, BP, and goal attainment of these values, and diabetes self-care behavior questionnaires at 6 months. Results The randomization groups were similar at baseline in all cardiovascular risk factors except for LDL, which was significantly lower in the MEDIC-E arm. At 6 months, significant improvements from baseline were found in the intervention arm for exercise, foot care, and goal attainment of A1C, LDL-C, and BP but not in the control arm. Conclusions The results of this study demonstrate that the pharmacist-led group intervention program for 6 months was an efficacious and sustainable collaborative care approach to managing diabetes and reducing associated cardiovascular risk.

Pharmacist-Led Group Medical Appointment Model in Type 2 Diabetes

Purpose The purpose of this study was to assess whether the VA-MEDIC (Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction), a pharmacist-led group medical visit program, could improve achievement of target goals in hypertension, hyperglycemia, hyperlipidemia, and tobacco use in patients with type 2 diabetes compared to usual care. Methods This was a randomized controlled trial of VA-MEDIC intervention in addition to usual care versus usual care alone in diabetic patients to reduce cardiac risk factors. VA-MEDIC consisted of a 40- to 60-minute educational component by nurse, nutritionist, physical therapist, or pharmacist followed by pharmacist-led behavioral and pharmacological interventions over 4 weekly sessions. Measures The attainment of target goals in hemoglobin A1C (A1C), blood pressure, fasting lipids, and tobacco use recommended by the American Diabetes Association. Results Of 118 participants, 109 completed the study. VA-MEDIC (n = 58) participants were younger and had greater tobacco use at baseline than usual care but were similar in other cardiovascular risk factors. After 4 months, a greater proportion of VA-MEDIC participants versus controls achieved an A1C of less than 7% and a systolic blood pressure less than 130 mm Hg. No significant change was found in lipid control or tobacco use between the 2 study arms. Conclusion Pharmacist-led group medical visits are feasible and efficacious for improving cardiac risk factors.

Pharmacist-Led Group Medical Appointments for the Management of Type 2 Diabetes with Comorbid Depression in Older Adults

Background:: Depression is associated with poor glycemic control, increased number of microvascular and macrovascular complications, functional impairment, mortality, and 4.5 times higher total health care costs in patients with diabetes. Shared medical appointments (SMAs) may be an effective method to attain national guideline recommendations for glycemic control in diabetes for patients with depression through peer support, counseling, problem solving, and improved access to care. Objective: To test the efficacy as assessed by attainment of a hemoglobin A1c (A1C) <7% of pharmacistted group SMA visits, Veterans Affairs Multidisciplinary Education in Diabetes and Intervention for Cardiac Risk Reduction in Depression (VA-MEDIC-D), in patients with type 2 diabetes mellitus. Methods: This was a randomized controlled trial of VA-MEDIC-D added to standard care versus standard care alone in depressed patients with diabetes with A1C >6.5%. VA-MEDIC-D consisted of 4 once-weekly, 2-hour sessions followed by 5 monthly 90-minute group sessions. Each SMA session consisted of multidisciplinary education and pharmacist-led behavioral and pharmacologic interventions for diabetes, lipids, smoking, and blood pressure. No pharmacologic interventions for depression were provided. The change in the proportion of participants who achieved an A1C <7% at 6 months was compared. Results: Compared to standard care (n = 44), a lower proportion of patients in VA-MEDIC-D (n = 44) had systolic blood pressure (SBP) <130 mm Hg at baseline, but were similar in other cardiovascular risk factors and psychiatric comorbidity. The change in the proportion of participants achieving an A1C <7% was greater in the VA-MEDIC-D arm than in the standard care arm (29.6% vs 11.9%), with odds ratio 3.6 (95% CI 1.1 to 12.3). VA-MEDIC-D participants also achieved significant reductions in SBP, low-density lipoprotein cholesterol, and non–high-density lipoprotein (HDL) cholesterol from baseline, whereas significant reductions were attained only in non–HDL cholesterol with standard care. There was no significant change in depressive symptoms for either arm. Conclusions: Pharmacist-led group SMA visits are efficacious in attainment of glycemic control in patients with diabetes and depression without change in depression symptoms.

Postdischarge community pharmacist-provided home services for patients after hospitalization for heart failure.

OBJECTIVE To establish a community pharmacist-provided home health service to improve medication adherence and reduce 30-day heart failure-related hospital readmissions. SETTING Visiting Nurse Services of Newport and Bristol Counties located in Portsmouth, RI, from December 2013 to April 2014. PRACTICE DESCRIPTION Each patient received one in-home visit provided by a Postgraduate Year 1 community pharmacy resident within 1 week of admission to visiting nurse services followed by two follow-up telephone calls, 1 week and 4 weeks after the visit. The in-home visit consisted of a baseline assessment of medication adherence using the Morisky 8-Item Medication Adherence Questionnaire as well as pharmacist-provided education regarding chronic heart failure management. The follow-up telephone calls were used to reassess patient adherence and to monitor for hospital readmission within 30 days of the initial in-home visit. PRACTICE INNOVATION Community pharmacist-provided in-home medication reconciliation and medication teaching has not been described in the literature previously. In addition, pharmacists are often not included on home health care teams placing patients undergoing transitions in care at risk for potential medication-related errors. MAIN OUTCOME MEASURES Improvement in medication adherence and reduction in 30-day heart failure-related hospital readmission rates. RESULTS Ten patients were enrolled from December 2013 through April 2014. Following intervention, all patients saw improvements in adherence questionnaire scores during follow-up. Hospital readmission rates for patients seen by the pharmacist were lower compared with agencywide figures over a similar time period. CONCLUSION A community pharmacist-provided in-home medication teaching service for patients following recent hospital discharge helps facilitate successful transitions of care from an inpatient to outpatient setting, improves medication adherence and has produced lower observed 30-day heart failure-related hospital readmission rates. Expansion of this or a similar service within the community pharmacy to reach as many patients as possible, including those not using visiting nurse services, could serve to only augment these benefits.

Efficacy of a Pharmacist-Led Cardiovascular Risk Reduction Clinic for Diabetic Patients With and Without Mental Health Conditions

Coexisting mental health conditions (MHCs) attenuate treatment effects in diabetes. A retrospective analysis was performed of a pharmacist-led cardiovascular risk reduction clinic (CRRC) targeting hypertension, diabetes, hyperlipidemia, and tobacco use in patients with at least one CRRC visit between January 2001 and January 2002. The United Kingdom Prospective Diabetes Study (UKPDS) risk change (after/before CRRC) for those with and without MHCs was compared. Of the 297 with diabetes and complete UKPDS data, 40.7% had at least 1 MHC (22.3% had a severe MHC). Patients with MHCs had a similar number of CRRC visits (4.7+/-2.6 vs 4.4+/-2.6) but had a lower baseline UKPDS score (0.31+/-0.18 vs 0.40+/-0.20; P=.001) compared with non-MHC patients. The risk change after CRRC was similar for those with and without MHCs (0.10+/-0.13 vs 0.10+/-0.14; P=.82), but patients with MHCs had a longer CRRC enrollment (245+/-152 vs 205+/-161 days; P<.03). The efficacy of the CRRC model to reduce cardiovascular risk is not attenuated by a concomitant MHC.

Availability and Accuracy of Information Regarding Nonprescription Emergency Contraception

Background: Although access to emergency contraception (EC) has increased with nonprescription status and approval of Plan B One-Step without age restrictions, barriers may still remain in patient education. This study assesses product availability and accuracy of information for EC among community pharmacies in Rhode Island, comparing changes from 2009 to 2012. Methods: Two female investigators posing as patients seeking EC followed a standardized script over telephone conversations. Investigators assessed EC availability, product use information, and cost at all community (retail) pharmacies in Rhode Island. Data were reported as group results with no identifiers. Chi-square and Fisher exact tests were used to analyze results. Results: During spring of 2009 and 2012, 165 and 171 pharmacies were telephoned, respectively. Approximately 90% of pharmacies stocked EC both years. In all, 62% versus 28% (P < .001) indicated EC should be taken as soon as possible; 82.5% versus 87.7% (P = .220) provided correct administration information; 67% versus 84% (P < .001) warned about adverse effects; and 67% versus 53% (P = .123) provided the correct minimum age for purchase. Conclusions: Access to nonprescription EC in Rhode Island is very good. Sites not stocking EC should reassess plans for patients to obtain medication. There is need for reeducation on EC labeling to improve counseling provided over the telephone.

Maintenance of Risk Factor Control in Diabetic Patients with and Without Mental Health Conditions After Discharge from a Cardiovascular Risk Reduction Clinic

Background: Diabetes and hypertension can be challenging to manage in patients with mental health conditions. While the effectiveness of a cardiovascular risk reduction clinic (CRRC) has been shown not to differ between those with and without mental health conditions, it is unknown whether patients with mental health conditions would differ in durability of success following discharge from the CRRC. Objective: To determine the effect of mental health conditions on the maintenance of glycemic control and blood pressure control in patients with diabetes following successful completion of a CRRC program. Methods: Patients were discharged from the CRRC when therapeutic goals of hemoglobin A1c (A1C) <7% and blood pressure <130/80 mm Hg were achieved. We performed a retrospective chart review of a cohort of 231 patients by quarterly intervals for A1C and systolic blood pressure (SBP), providing up to 3 years of data following discharge from the CRRC. We assessed the time to failure to maintain goal A1C and SBP following CRRC discharge for patients with diagnosed mental health conditions versus patients without mental health conditions. Results: For patients with and without mental health conditions, 50% of those who had been discharged from the CRRC with an SBP goal of <130 mm Hg failed to maintain SBP by 1 quarter. The hazard ratio for failure to maintain SBP, with those without mental health conditions as the reference group, was 0.96 (95% CI 0.68 to 1.35). Overall, for patients with an A1C goal of <7%, the combined median time to failure was 3 quarters. Among patients without mental health conditions, 25% failed in 3 quarters, and of those with mental health conditions, 25% failed in 4 quarters (HR 0.91; 95% CI 0.50 to 1.66). Conclusions: There was no significant difference between diabetic patients with and without mental health conditions in maintenance of A1C and SBP after discharge from a CRRC. This provides further evidence that a CRRC is a viable approach to cardiovascular risk reduction in individuals with mental health conditions.

Pharmacist medication therapy management in home health care: Investigation of a sustainable practice model

OBJECTIVES The objective of this study was to quantify the financial impact of a pharmacist-driven pilot medication therapy management (MTM) program within a visiting nurse service (VNS) and identify types of medication-related problems affecting the home health care population. METHODS Patients were contacted to schedule a home visit with the primary investigator. At the appointment, a comprehensive medication review (CMR) was completed, and data collected included primary reason for VNS care, comorbid diagnoses, number of prescription and nonprescription medications at time of visit, and type of pharmacist-identified medication therapy intervention(s). The VNS is a nonprofit independent home health care agency serving patients of all ages and health conditions. Patients admitted with primary insurance coverage through Blue Cross Blue Shield (BCBSRI) Blue Chip for Medicare and 65 years of age and older were eligible for inclusion. Intervention categories were aligned to coordinate with current billable OutcomesMTM claim categories. Dollar allocation for each intervention severity level was assigned according to the predetermined Medicare cost savings predicted value from BCBSRI. Interventions were assigned cost-saving value by the severity level to estimate savings. RESULTS Twenty-five patients received CMRs. Patients averaged 5.92 chronic health conditions, 8.48 Part D drugs, and 3.88 over-the-counter medications. Two hundred eighteen medication-related problems were identified spanning 13 intervention categories. Intervention severity level was assigned to the medication-related problems, with calculated cost savings from pharmacist interventions totaling

Costs and effectiveness of pharmacist-led group medical visits for type-2 diabetes: A multi-center randomized controlled trial

124,352. CONCLUSION This pilot study demonstrated the positive economic impact of a pharmacist-run MTM program at VNS for patients with multiple chronic conditions and medication-related problems. Potential societal benefits include that community members admitted to VNS will continue to have access to a pharmacist as a standard of care with the continuation of this MTM program.

Group medical visits after heart failure hospitalization: Study protocol for a randomized-controlled trial

Objectives The effectiveness and costs associated with addition of pharmacist-led group medical visits to standard care for patients with Type-2 Diabetes Mellitus (T2DM) is unknown. Methods Randomized-controlled-trial in three US Veteran Health Administration (VHA) Hospitals, where 250 patients with T2DM, HbA1c >7% and either hypertension, active smoking or hyperlipidemia were randomized to either (1) addition of pharmacist-led group-medical-visits or (2) standard care alone for 13 months. Group (4–6 patients) visits consisted of 2-hour, education and comprehensive medication management sessions once weekly for 4 weeks, followed by quarterly visits. Change from baseline in cardiovascular risk estimated by the UKPDS-risk-score, health-related quality-of-life (SF36v) and institutional healthcare costs were compared between study arms. Results After 13 months, both groups had similar and significant improvements from baseline in UKPDS-risk-score (-0.02 ±0.09 and -0.04 ±0.09, group visit and standard care respectively, adjusted p<0.05 for both); however, there was no significant difference between the study arms (adjusted p = 0.45). There were no significant differences on improvement from baseline in A1c, systolic-blood-pressure, and LDL as well as health-related quality-of-life measures between the study arms. Compared to 13 months prior, the increase in per-person outpatient expenditure from baseline was significantly lower in the group visit versus the standard care arm, both during the study intervention period and at 13-months after study interventions. The overall VHA healthcare costs/person were comparable between the study arms during the study period (p = 0.15); then decreased by 6% for the group visit but increased by 13% for the standard care arm 13 months post-study (p<0.01). Conclusions Addition of pharmacist-led group medical visits in T2DM achieved similar improvements from baseline in cardiovascular risk factors than usual care, but with reduction in the healthcare costs in the group visit arm 13 months after completion compared to the steady rise in cost for the usual care arm. Trial registration NCT00554671 ClinicalTrials.gov