Measuring diabetes care in the national interdisciplinary primary care practice-based research network (NIPC-PBRN).

STUDY OBJECTIVE: To assess diabetes care in a network of primary care practices that include pharmacist support by using a scoring system designed for the National Committee for Quality Assurance (NCQA) Diabetes Recognition Program (DRP) measures. DESIGN: Retrospective medical record review. DATA SOURCE: Subset of the National Interdisciplinary Primary Care Practice-Based Research Network (NIPC-PBRN). PATIENTS: A total of 1309 adults who were seen at 17 practices for an outpatient diabetes mellitus visit between January 1 and June 30, 2008. MEASUREMENTS AND MAIN RESULTS: Patient demographic data and NCQA DRP process and outcome measures (hemoglobin A(1c) [A1C], blood pressure, and low-density lipoprotein cholesterol [LDL] level measurements; eye and foot examinations; nephropathy assessment; and smoking status and cessation advice or treatment) were recorded. Points for each measure were compiled, and practices achieving a sufficient score for NCQA recognition (≥ 75.0 points) were identified. Pharmacists were also surveyed regarding their services, participation in quality improvement initiatives, use of electronic medical records, and methods of data extraction. The relationships between DRP measures and quality improvement activities, pharmacist involvement in diabetes care, and use of electronic medical records were analyzed. The DRP outcome measures were satisfactory: mean ± SD A1C 7.6% ± 1.9%, LDL level 99.1 ± 35.1 mg/dl, and systolic and diastolic blood pressures 130.2 ± 18.1 and 74.4 ± 10.8 mm Hg, respectively. Five practices (29%) achieved a sufficient score for NCQA recognition. No significant relationships were noted between DRP measures and participation in quality improvement, type of clinical pharmacy services, or use of electronic medical records (p>0.05). In a regression analysis, only electronic medical record use was significantly related to DRP measures (p=0.02). CONCLUSION: Diabetes care in the NIPC-PBRN appears satisfactory, but improvements are necessary if NCQA recognition is the goal. Use of electronic medical records was associated with better DRP measures.

Pharmacist-physician comanagement of hypertension and reduction in 24-hour ambulatory blood pressures.

BACKGROUND: Pharmacist-physician comanagement of hypertension has been shown to improve office blood pressures (BPs). We sought to describe the effect of such a model on 24-hour ambulatory BPs. METHODS: We performed a prospective, cluster-randomized, controlled clinical trial, enrolling 179 patients with uncontrolled hypertension from 5 primary care clinics in Iowa City, Iowa. Patients were randomized by clinic to receive pharmacist-physician collaborative management of hypertension (intervention) or usual care (control) for a 9-month period. In the intervention group, pharmacists helped patients to identify barriers to BP control, counseled on lifestyle and dietary modifications, and adjusted antihypertensive therapy in collaboration with the patients' primary care providers. Patients were seen by pharmacists a minimum of every 2 months. Ambulatory BP was measured at baseline and at study end. RESULTS: Baseline and end-of-study ambulatory BP profiles were evaluated for 175 patients. Mean (SD) ambulatory systolic BPs (SBPs), reported in millimeters of mercury, were reduced more in the intervention group than in the control group: daytime change in (Δ) SBP, 15.2 (11.5) vs 5.5 (13.5) (P < .001); nighttime ΔSBP, 12.2 (14.8) vs 3.4 (13.3) (P < .001); and 24-hour ΔSBP, 14.1 (11.3) vs 5.5 (12.5) (P < .001). More patients in the intervention group than in the control group had their BP controlled at the end of the study (75.0% vs 50.7%) (P < .001), as defined by overall 24-hour ambulatory BP monitoring. CONCLUSION: Pharmacist-physician collaborative management of hypertension achieved consistent and significantly greater reduction in 24-hour BP and a high rate of BP control. Trial Registration  clinicaltrials.gov Identifier: NCT00201045.

A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control.

UNLABELLED: Numerous studies have demonstrated the value of team-based care to improve blood pressure (BP) control, but there is limited information on whether these models would be adopted in diverse populations. The purpose of this study was to evaluate whether a collaborative model between physicians and pharmacists can improve BP control in multiple primary care medical offices with diverse geographic and patient characteristics and whether long-term BP control can be sustained. This study is a randomized prospective trial in 27 primary care offices first stratified by the percentage of underrepresented minorities and the level of clinical pharmacy services within the office. Each office is then randomized to either a 9- or 24-month intervention or a control group. Patients will be enrolled in this study until 2012. The results of this study should provide information on whether this model can be implemented in large numbers of diverse offices, if it is effective in diverse populations, and whether BP control can be sustained long term. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00935077.

Effect of self-efficacy and social support on adherence to antihypertensive drugs.

STUDY OBJECTIVE: To determine the relationship between poor adherence and self-efficacy or social support after a pharmacist intervention. DESIGN: Post-hoc analysis of data from two randomized controlled trials of physician-pharmacist collaborative interventions (6 and 9 mo, respectively) to improve blood pressure control. SETTING: Eleven university-affiliated primary care clinics. PATIENTS: Five hundred eighty-four patients (aged 21-85 yrs) with uncontrolled primary hypertension; 296 were in the intervention group and 288 were in the control group. INTERVENTION: Pharmacists provided intensified hypertension management and drug adherence counseling to patients in the intervention group. MEASUREMENTS AND MAIN RESULTS: Social support and self-efficacy questionnaires were administered at baseline and end-of-study visits. Patient adherence was monitored by using the Morisky self-reported adherence questionnaire. Self-reported adherence scores improved significantly in the control group (p=0.0053) but not in the intervention group; however, adherence at baseline in both groups was high. There were small, but significant, improvements in self-efficacy (p<0.04) and social support (p<0.05) scores in the intervention group but not the control group at the end of the study. Social support and, to a lesser extent, self-efficacy improved as a function of duration of study participation (9-mo vs 6-mo intervention), regardless of whether the patient received the intervention. Blood pressure control in both groups improved significantly at the end of the study; however, mean blood pressure was significantly lower in the intervention group (129.7/76.6 mm Hg) compared with the control group (140.8/78.9 mm Hg; p<0.0001 for systolic, p=0.032 for diastolic). CONCLUSION: Social support and self-efficacy improved significantly in the intervention group at the end of the pharmacist intervention. Drug adherence was correlated with self-efficacy even though drug adherence did not improve significantly in the intervention group. The fact that social support and self-efficacy improved as a function of duration of study participation suggests that participation in a research study may have had a positive influence on these measures. Even though the changes in social support, self-efficacy, and drug adherence were modest, there was significantly better blood pressure control in the intervention group compared with the control group. These findings indicate that changes in drug adherence, self-efficacy, or social support probably played a minor role in the blood pressure outcomes in these studies.

Influence of patient characteristics on success of ambulatory blood pressure monitoring.

STUDY OBJECTIVE: To examine the influence of specific patient characteristics on the success of ambulatory blood pressure monitoring (ABPM). DESIGN: Retrospective analysis. SETTING: University-affiliated family care center. PATIENTS: Five hundred thirty patients (mean age 52.7 yrs, range 14-90 yrs) who were undergoing ABPM between January 1, 2001, and July 1, 2007. MEASUREMENT AND MAIN RESULTS: Specific patient characteristics were identified through an electronic medical record review and then examined for association with ABPM session success rate. These patient characteristics included age, sex, weight, height, body mass index (BMI), occupation, clinic blood pressure, travel distance to clinic, and presence of diabetes mellitus or renal disease. The percentage of valid readings obtained during an ABPM session was analyzed continuously (0-100%), whereas overall session success was analyzed dichotomously (0-79% or 80-100%). Univariate and multivariate regression analyses were performed to examine the influence of patient characteristics on the percentage of valid readings and the overall likelihood of achieving a successful session. In the 530 patients, the average percentage of valid readings was 90%, and a successful ABPM session (>or= 80% valid readings) was obtained in 84.7% (449 patients). A diagnosis of diabetes was found to negatively predict ABPM session success (continuous variable analysis, p=0.019; dichotomous variable analysis, odds ratio [OR] 0.45, 95% confidence interval [CI] 0.23-0.87, p=0.019), as did renal disease (continuous variable analysis, p=0.006; dichotomous variable analysis, OR 0.39, 95% CI 0.17-0.90, p=0.027) and increasing BMI (continuous variable analysis, p<0.001; dichotomous variable analysis, OR 0.78, 95% CI 0.65-0.93, p=0.005). Renal disease and BMI remained significant predictors in adjusted analyses. CONCLUSION: For most patients, ABPM was successful; however, elevated BMI and renal disease were associated with less complete ABPM session results. Adaptation and individualization of the ABPM process may be necessary to improve results in these patients.

Reduction in adverse symptoms as blood pressure becomes controlled.

STUDY OBJECTIVES: To evaluate trends in adverse symptoms as blood pressure becomes controlled, and to determine if these symptoms are influenced by social support and self-efficacy. DESIGN: Secondary analysis from a randomized controlled study of physician-pharmacist collaboration to improve blood pressure control. SETTING: Five university-affiliated primary care clinics. PATIENTS: A total of 179 patients (aged 21-85 yrs) with uncontrolled primary hypertension who were taking no antihypertensive drugs or up to three antihypertensive drugs at baseline were randomized to the intervention group, in which pharmacists were involved in their care, or to the control group, who received usual care from their physicians. Of these patients, 160 completed the study: 92 were in the intervention group, and 68 were in the control group. INTERVENTION: In both groups, patient-reported symptoms suggestive of adverse drug reactions (ADRs) were recorded at each study visit with use of a structured ADR questionnaire. Social support and self-efficacy questionnaires were also administered at each study visit. MEASUREMENTS AND MAIN RESULTS: Patients' ADR scores decreased significantly from baseline to the end of the study in both the control (from a mean of 26.5 to 18.4) and intervention (from 29.9 to 22.7) groups (p<0.0001 for both comparisons), although no significant difference was noted between groups. The mean +/- SD number of antihypertensive drugs/patient increased in both the intervention (from 1.5 +/- 1.0 to 2.4 +/- 0.9 drugs) and control (from 1.4 +/- 1.0 to 1.9 +/- 1.0 drugs) groups; however, the difference between groups was significant only at the end of the study. Additional analyses were performed on self-efficacy and social support to determine a potential reason for the reduction in ADR scores despite an increase in drug use. Improvements in self-efficacy and social support scores were significantly and independently associated with improvement in ADR score (p<0.05). CONCLUSIONS: In both groups, ADR scores improved despite an increase in antihypertensive drug use. Improvements in social support and, to a lesser extent, self-efficacy were associated with improvements in ADR scores. Patients should not expect an increase in distressful symptoms as their blood pressure becomes controlled with antihypertensive drugs, especially when adequate social support is available.

How well does a shortened time interval characterize results of a full ambulatory blood pressure monitoring session?

Ambulatory blood pressure monitoring (ABPM) is useful in evaluating cardiovascular risk but requires significant time. The authors examined how closely shortened time intervals correlate with the systolic blood pressure (BP) determined from a full 24-hour ABPM session in 1004 ABPM recordings. After excluding the first hour, Pearson correlations performed for the mean systolic BP of the subsequent 3-, 5-, and 7-hour periods (4, 6, and 8 hours total) with the entire, and remainder of the session, demonstrated greatest improvement in correlation when the session is increased from 4 to 6 hours. Bland-Altman analysis of the 6-hour time period revealed a mean difference of 5.41 mm Hg compared with the full session mean. The authors conclude that 6-hour ABPM can approximate the overall mean BP obtained from full 24-hour ABPM. However, shortened sessions do not characterize the influence of circadian variation on the 24-hour mean BP and may overestimate the 24-hour BP levels.

Description of pharmacist interventions during physician-pharmacist co-management of hypertension.

OBJECTIVE: The aim of this study is to describe recommendations made by clinical pharmacists when co-managing hypertension with physicians. SETTING: Two family medicine clinics at a major teaching hospital in the mid-western United States. METHOD: This report details the specific recommendations made by pharmacists during a prospective randomized controlled clinical trial. Patients with uncontrolled hypertension were enrolled in a 9-month intensive pharmacist-physician co-management study. Clinical pharmacists saw patients at baseline, 2, 4, 6, and 8 month visits. Optional visits were allowed between required visits. MAIN OUTCOME MEASURE: For this analysis, pharmacist recommendations were grouped. Physician acceptance of the pharmacists' recommendations was also evaluated. RESULTS: Data from 101 patients were included and analyzed in this study. Changes in drug therapy were recommended 267 times for these 101 patients. Most recommendations for a change in treatment involved adding a new antihypertensive medication (46.4%) or increasing a dose (33.3%). The majority of pharmacist recommendations to modify drug therapy were made at the baseline visit (41.6%), with 76.8% of recommendations made by the 2 month visit. Physicians accepted and implemented 95.9% of the 267 pharmacist recommendations to modify drug therapy. Pharmacists recommended no change in the treatment plan 361 times, most often because the patient's blood pressure (BP) had achieved the goal. Average BP decreased from 153.1+/-10.0/84.9+/-12.0 mmHg (average+/-SD) at baseline to 124.2+/-9.7/74.7+/-9.6 mmHg (P<0.001) at the end of 9 months, with 89.1% (P<0.001) of patients reaching their BP goal. CONCLUSION: Pharmacist recommendations for alterations in drug therapy generally occurred early in the course of the study and were largely to intensify therapy through higher dosages or additional medications. Pharmacist-physician co-management of BP is effective at reducing BP and improving BP control rates.

Formation of a primary care pharmacist practice-based research network.

PURPOSE: The results of a survey conducted to characterize participating practice sites, patient populations, and collaborative physician-pharmacist services provided through an emerging practice-based research network (PBRN) in the primary care setting are presented. METHODS: A targeted sample of faculty pharmacist investigators practicing in primary care settings were selected for participation in this PBRN based on several factors, including past research activities, their interest in soliciting additional clinics within their state to participate in a research network, the potential for regional collaboration, geographic location, and the patient population served. A baseline survey to characterize the PBRN was distributed to members of the PBRN in June 2006. Data were analyzed using descriptive statistics. RESULTS: A total of 81 pharmacists in 48 practice sites were recruited to join the PBRN. Most practice sites were located within family medicine residency programs, and the majority were affiliated with a community hospital or health system. Half of participating practices had 300-599 ambulatory care visits per week. Pharmacists in the PBRN spent their time performing direct patient management and had collaborative practice agreements with physicians. Patient revenue was used to cover pharmacist salaries in about one fifth of the practice sites. Pharmacists in the PBRN reported participation in diverse educational activities, such as point-of-care resident education and curbside consultation in the clinic hallways or their office. CONCLUSION: Eighty-one pharmacists from 48 primary care practice sites in 11 states were recruited to join a PBRN. These pharmacists provided descriptive data regarding their practice site, characteristics of patients served, and clinical services provided as a first step in collaborative research efforts.

Antioxidants, supplements, and Parkinson's disease.

OBJECTIVE: To review the use of antioxidants and other supplements for the prevention and treatment of Parkinson's disease (PD). DATA SOURCES: Biomedical literature was accessed through MEDLINE (1996-June 2005); key search terms included Parkinson's disease, coenzyme Q10 (CoQ10), antioxidants, supplements, and glutathione. Pertinent references cited in those articles were also evaluated for inclusion in this review. DATA SYNTHESIS: Three main antioxidants or supplements have been studied for use in the prevention or treatment of PD: tocopherol, CoQ10, and glutathione. These agents have been studied because of their potential to alter the course of 2 common theories of PD pathogenesis: free radical generation and mitochondrial complex-1 deficiency. The literature search revealed 3 large clinical studies of tocopherol (2 observational, 1 prospective randomized), 4 trials of CoQ10, and 1 study of glutathione. With the exception of the large observational studies with tocopherol and one study of CoQ10 that enrolled 80 patients, each of the other studies retrieved included fewer than 30 patients and were conducted for 3 months or less. Antioxidant supplementation, in particular tocopherol, did not appear to alter the course of PD. However, in 2 of the studies of CoQ10 and in the study of glutathione, a small but statistically significant improvement in PD symptoms was observed. CONCLUSIONS: At present, antioxidants and supplements appear to have a limited role in the prevention or treatment of PD. Of those reviewed here, CoQ10 appears to provide some minor treatment benefits. More study is necessary to determine whether CoQ10 has a significant role as primary or adjunctive therapy in PD.