Impact of interactive voice response technology on primary adherence to bisphosphonate therapy: a randomized controlled trial.

UNLABELLED: Osteoporosis (weak bones) is a disorder that has high morbidity, mortality, and healthcare utilization. Effective treatment is available for this disorder, but many patients choose not to start therapy. This is the first study showing an intervention that increases the initiation rates to medications for osteoporosis. INTRODUCTION: One out of six patients prescribed an oral bisphosphonate does not initiate therapy, a phenomenon known as primary non-adherence. Reasons for bisphosphonate primary non-adherence have been identified, but not interventions that positively impact primary adherence rates. The purpose of this study is to determine the effectiveness of interactive voice response technology to improve oral bisphosphonate primary adherence. METHODS: This was a prospective, randomized controlled trial conducted in January-December 2014 at Kaiser Permanente Colorado, an integrated healthcare system. Adults with a new oral bisphosphonate prescription for osteoporosis or osteopenia which was not purchased within 14-20 days of being ordered were included. There were 127 and 118 patients in the intervention group and control groups, respectively. The intervention group received an interactive voice response phone call followed by a letter 1 week later if primary non-adherence continued, whereas the control group did not receive any outreach. The primary outcome was the proportion of patients who purchased their oral bisphosphonate within 25 days of randomization. RESULTS: There were 62/127 (48.8%) intervention patients and 36/118 (30.5%) control patients who purchased their bisphosphonate prescription within 25 days of randomization (OR = 2.17, 95% CI 1.29-3.67). When adjusted for age, sex, history of bone mineral density scan and fracture, the odds ratio for intervention versus control group was 2.3 (95% CI 1.34-3.94). CONCLUSION: An interactive voice response phone call and follow-up letter significantly improved primary adherence to oral bisphosphonate therapy. Such an intervention could be considered for improving primary adherence rates to other medication classes.

Reduced quality of life in veterans at risk for drug-related problems.

The relationships between drug therapy and health-related quality of life in 1054 patients who received care from Department of Veterans Affairs medical centers (VAMCs) were assessed. Patients at high risk for drug-related problems were enrolled into a pharmaceutical care study at nine VAMCs. On enrollment, the short form (SF)-36 was completed and medical records were examined for evidence of coexisting illness. Drug therapy in the year before enrollment was analyzed in relation to SF-36 scores. Mean +/- SD SF-36 scores ranged from 37.99+/-41.70 for role physical to 70.78+/-18.97 for mental health domains, with all domain scores significantly below age-adjusted national norms (p<0.05). Patients taking a drug that required therapeutic monitoring had significantly lower SF-36 scores (p=0.0001 to p=0.0033) across all domains except for bodily pain and mental health, compared with patients not taking these agents.

Interpreting the findings of the IMPROVE study.

Various findings of the Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers (IMPROVE) study are reviewed. Suggestions for future methodologies that will enhance this study are discussed. The IMPROVE study is one of the largest pharmaceutical care studies conducted. Although it was an intervention study that examined global outcomes following management by pharmacists, it was designed as an effectiveness study. Several new practice and research methods were developed, including a method to identify patients at high risk for drug-related problems utilizing pharmacy databases, a method to identify chronic diseases using pharmacy databases, a method to evaluate the structure and process for delivering pharmaceutical care in Veterans Affairs medical centers (VAMCs), and guidelines for providing care to patients in the IMPROVE study. Nine VAMCs participated in the study, and 1054 patients were randomized to either an intervention group (n = 523) or a control group (n = 531). Pharmacists documented a total of 1855 contacts with the intervention group patients and made 3048 therapy-specific interventions over the 12-month study period. There was no meaningful difference in patient satisfaction or quality of life in the two groups. Selected disease-specific indicators found an improved rate of measurement of hemoglobin A1c tests and better control of total and low-density-lipoprotein (LDL) cholesterol levels in the intervention group compared with the control group. Total health care costs increased in both groups over the 12-month period. The mean increase in costs in the intervention group was $1020, which was lower than the control group's value of $1313. The lessons learned from the IMPROVE study suggest to future investigators how to study and measure the effects of clinical pharmacy services on patient outcome.

Can clinical pharmacists affect SF-36 scores in veterans at high risk for medication-related problems?

BACKGROUND: An objective of pharmaceutical care is for pharmacists to improve patients' health-related quality of life (HRQOL) by optimizing medication therapy. OBJECTIVES: The objective of this study was to determine whether ambulatory care clinical pharmacists could affect HRQOL in veterans who were likely to experience a drug-related problem. RESEARCH DESIGN: This was a 9-site, randomized, controlled trial involving Veterans Affairs Medical Centers (VAMCs). Patients were eligible if they met > or = 3 criteria for being at high risk for drug-related problems. Enrolled patients were randomized to either usual medical care or usual medical care plus clinical pharmacist interventions. HRQOL was measured with the SF-36 questionnaire administered at baseline and at 6 and 12 months. RESULTS: In total, 1,054 patients were enrolled; 523 were randomized to intervention, and 531 to control. After patient age, site, and chronic disease score were controlled for, the only domain that was significantly different between groups over time was the bodily pain scale, which converged to similar values at the end of the study. Patients' rating of the change in health status in the past 12 months was statistically different between groups, intervention patients declining less (-2.4 units) than control subjects (-6.3 units) (P < 0.004). This difference was not considered clinically meaningful. However, a dose-response relationship was observed for general health perceptions (P = 0.004), vitality (P = 0.006), and change in health over the past year (P = 0.007). CONCLUSIONS: These results suggest that clinical pharmacists had no significant impact on HRQOL as measured by the SF-36 for veterans at high risk for medication-related problems.

Clinical and economic impact of ambulatory care clinical pharmacists in management of dyslipidemia in older adults: the IMPROVE study. Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers.

We examined the impact of ambulatory care clinical pharmacist interventions on clinical and economic outcomes of 208 patients with dyslipidemia and 229 controls treated at nine Veterans Affairs medical centers. This was a randomized, controlled trial involving patients at high risk of drug-related problems. Only those with dyslipidemia are reported here. In addition to usual medical care, clinical pharmacists were responsible for providing pharmaceutical care for patients in the intervention group. The control group did not receive pharmaceutical care. Seventy-two percent of the intervention group and 70% of controls required secondary prevention according to the National Cholesterol Education Program guidelines. Significantly more patients in the intervention group had a fasting lipid profile compared with controls (p=0.021). The absolute change in total cholesterol (17.7 vs 7.4 mg/dl, p=0.028) and low-density lipoprotein (23.4 vs 12.8 mg/dl, p=0.042) was greater in the intervention than in the control group. There were no differences in patients achieving goal lipid values or in overall costs despite increased visits to pharmacists. Ambulatory care clinical pharmacists can significantly improve dyslipidemia in a practice setting designed to manage many medical and drug-related problems.

An economic analysis of a randomized, controlled, multicenter study of clinical pharmacist interventions for high-risk veterans: the IMPROVE study. Impact of Managed Pharmaceutical Care Resource Utilization and Outcomes in Veterans Affairs Medical Centers.

STUDY OBJECTIVE: To determine if clinical pharmacists could affect economic resource use and humanistic outcomes in an ambulatory, high-risk population. DESIGN: Prospective, randomized, controlled study. SETTING: Nine Veterans Affairs medical centers. PATIENTS: Patients who were at high risk for medication-related problems. INTERVENTION: Patients were randomized to usual medical care with input from a clinical pharmacist (intervention group) or just usual medical care (control group). MEASUREMENTS AND MAIN RESULTS: Of 1,054 patients enrolled, 523 were randomized to the intervention group and 531 to the control group. The number of clinic visits increased in the intervention group (p=0.003), but there was no difference in clinic costs. Mean increases in total health care costs were $1,020 for the intervention group and $1,313 for the control group (p=0.06). CONCLUSION: Including the cost of pharmacist interventions, overall health care expenditures were similar for patients randomized to see a clinical pharmacist versus usual medical care.

The relationship between drug therapy noncompliance and patient characteristics, health-related quality of life, and health care costs.

The objectives of this study were to determine the relationship between drug therapy compliance and risk of hospitalization and economic outcomes, and to identify potential indicators of compliance. We used computerized prescription records from 1,054 patients at high risk for drug-related problems. We calculated a compliance ratio for a 12-month period and correlated it with health care use, demographic variables, drug-related variables, and scores for health-related quality of life. Univariate results suggested that increased age (p=0.05), high number of chronic conditions (p<0.001), and high number of concurrent drugs (p<0.001) were positively correlated with compliance. That is, increased values for these variables were associated with better compliance. Using logistic regression, the odds of being noncompliant was 0.665 as the number of chronic conditions increased. Compliance was not a predictor of concurrent or future hospitalizations or mortality, nor was it a significant predictor of health care costs.

Types of interventions made by clinical pharmacists in the IMPROVE study. Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers.

The purpose of this study was to describe and evaluate the activities and interventions provided by ambulatory care clinical pharmacists during the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study. A total of 523 patients were randomized into the intervention arm at nine Veterans Affairs medical centers if they were considered to be at high risk for drug-related problems. Patients randomized to the control group had no interventions and they are not reported. Using a standard form, pharmacists were asked to document the length of visit, method of contact, medical conditions addressed, and drug-related problems addressed and resolved during each contact. Seventy-eight ambulatory care clinical pharmacists documented 1855 contacts over 12 months, an average of 3.54 +/- 2.31/patient. The length of visits was 15 minutes or more for 73% of contacts. In-person contacts accounted for 1421 visits (76.6%), with the remainder being telephone contacts. During each contact the average number of drug-related problems addressed and resolved were 1.64 +/- 1.16 and 1.14 +/- 0.98, respectively. More drug-related problems were addressed and resolved when visits were 15 minutes or longer (p=0.001) and when the contact was in person (p=0.001). These data may provide information to clinical pharmacists developing pharmacy-managed clinics for patients at high risk for drug-related problems. The information may be a benchmark for types of interventions that can be made, as well as the time commitments required to make them.

Assessing the structure and process for providing pharmaceutical care in Veterans Affairs medical centers.

The structure and process used in providing pharmaceutical care to ambulatory care patients at nine Veterans Affairs medical centers (VAMCs) were studied. Institutions participating in the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study were selected. To assess the level of pharmaceutical care services provided to ambulatory care patients, 10 critical domains were identified. Six instruments with questions related to each domain were then designed, including a clinical pharmacist survey and an outpatient pharmacist survey. Each center was assessed through three surveys and an onsite visit. The investigators used both direct observation and a consensus approach to score the level of ambulatory care pharmaceutical services provided. The clinics in which IMPROVE study patients would be seen were run by pharmacists (33%), physicians (44%), and multidisciplinary teams (22%). Of the 51 clinical pharmacists surveyed, 23 (45%) had prescribing authority via protocols, 14 (28%) had unrestricted prescribing privileges, and 14 did not have prescribing authority. The sites varied greatly in referral patterns, methods of identifying patients, and whether patient visits were scheduled or on a walk-in basis. There was a strong correlation between observed activities by clinical pharmacists and their self-reports and between observed activities by outpatient pharmacists and their self-reports. Activities reported by clinical pharmacists were moderately but not significantly correlated with consensus scores, and activities reported by outpatient pharmacists were poorly correlated with consensus scores. The structure and process for providing pharmaceutical care to ambulatory care patients at VAMCs were evaluated with surveys, direct observation, and a consensus-based scoring system.

Development of a chronic disease indicator score using a Veterans Affairs Medical Center medication database. IMPROVE Investigators.

OBJECTIVE: Develop a chronic disease index that approximates the number of chronic diseases a patient has using a medication database. METHODS: An expert panel determined whether specific medication classes could be indicative of a chronic disease. Those classes identified were incorporated into a computer program and then used to screen the medication records of 246 randomly selected patients to estimate the number of chronic diseases present in each patient. This number was designated as the chronic disease index (CDI). The CDI was then validated against chart review. The CDI and a measure of disease severity, the chronic disease score (CDS) also were compared. The sensitivity and specificity of the computer program was analyzed for seven common chronic diseases. RESULTS: The expert panel designated 54 drug classes containing medications used to treat chronic diseases. The CDI correlated moderately with the number of chronic diseases found via chart review (r = 0.65; P = 0.001) and highly with the CDS (r = 0.81; P = 0.001). The index predicted the presence of three common diseases with a sensitivity of > or = 75%, and of six common diseases with a specificity of > or = 75%. CONCLUSIONS: The CDI correlates moderately well with the actual number of chronic disease states present. This tool may be useful for researchers when trying to identify patients with specific diseases and also for risk adjustment.

Estimating risk factors for patients with potential drug-related problems using electronic pharmacy data. IMPROVE investigators.

OBJECTIVE: To validate a computer-based program to identify patients at high risk for drug-related problems. DESIGN: Computerized analysis of pharmacy dispensing records and manual review of medical records. SETTING: Ambulatory clinics at a Veterans Affairs Medical Center. PATIENTS: 246 randomly selected patients who were receiving at least one outpatient medication in the previous 24 months. MAIN OUTCOME MEASURES: Presence of six previously established criteria regarding medication use. These criteria are five or more medications, > or = 12 doses per day, four or more changes to the medication regimen, three or more chronic diseases, history of noncompliance, and presence of a drug requiring therapeutic drug monitoring (TDM). RESULTS: Spearman rho rank order correlation coefficients ranged from 0.63 to 0.91 for criteria pertaining to the number of medications, daily doses, changes in the medication regimen, and number of chronic diseases (all significant, p = 0.0001). The computer program underestimated the number of chronic diseases and overestimated the number of daily doses. The level of agreement between the computer program and chart review for patient noncompliance was low (Kappa = 0.38), with the computer more likely to indicate a patient was noncompliant. A high level of agreement was seen between the computer program and chart review for the presence of a drug requiring TDM (Kappa = 0.83). For all six criteria, the computer program had a sensitivity of 65.7% and specificity of 88.2%. CONCLUSIONS: When compared with medical records, the use of this program to evaluate electronic pharmacy data can be efficient to screen large numbers of patients who may be at high risk for drug-related problems. This method may be useful for clinical pharmacists in providing pharmaceutical services to patients who are most likely to benefit.

Mibefradil: a new class of calcium-channel antagonists.

OBJECTIVE: To describe the pharmacology, pharmacokinetics, and clinical efficacy of mibefradil compared with other agents used for hypertension and angina. DATA SOURCES: A MEDLINE search was performed for the period of January 1980 through September 1997 using the key terms mibefradil or Ro 40-5967. All articles written in English were considered for review. STUDY SELECTION AND DATA EXTRACTION: All clinical studies involving mibefradil were evaluated. Preclinical data were included if these data were not adequately represented in clinical (human) studies. DATA SYNTHESIS: Mibefradil is the first member of a new class of calcium-channel antagonists (CCAs) that block the T-type calcium channels. A long elimination half-life makes once-daily dosing feasible, and the drug's lack of negative inotropy and reflex tachycardia distinguishes it from other available CCAs. When administered at recommended dosages (50 or 100 mg once daily), mibefradil reduces blood pressure over 24 hours in patients with hypertension, improves exercise capacity, and relieves anginal symptoms in patients with chronic stable angina pectoris. CONCLUSIONS: Clinical studies have found that the antihypertensive effects of mibefradil are comparable with those of nifedipine, verapamil, and amlodipine, and more effective than those of diltiazem. These effects result from peripheral vasodilation and a slight reduction in heart rate. Selective vasodilation of the coronary vasculature makes it an effective antianginal agent when used alone or added to beta-blocker therapy. Mibefradil demonstrates no significant effects on cardiac contractility, and no adrenergic stimulation resulting in reflex tachycardia. Therefore, it may have some advantages over currently available CCAs, especially in patients with congestive heart failure, although such advantages are unproven in published clinical trials. Ongoing clinical studies, including the Mortality Assessment in Congestive Heart Failure Trial (MACH-1) currently in progress, are needed to clarify mibefradil's place in cardiovascular therapy.

The IMPROVE study: background and study design. Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers.

An ongoing study of the impact of ambulatory care clinical pharmacists on patient outcomes at selected Veterans Affairs medical centers (VAMCs) is described. The IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study will examine the effects of referring patients at high risk for drug-related problems to a pharmacist-managed monitoring program. Nine study sites from diverse geographic locations and small and large urban areas have been selected. Investigators visited each site to evaluate the structure of care, observe pharmacist-patient interactions, and assess the level and documentation of pharmacists' activities. A coordinating center will collect and process patient-specific data from the study sites to identify high-risk patients. It is expected that 500 intervention patients and 500 control patients from the nine VAMCs will complete all portions of the study. Intervention patients will be scheduled for medication assessments by ambulatory care pharmacists and will be monitored by pharmacists for at least 12 months. The coordinating center will track refill histories for intervention patients. Investigators will assess the activities performed by ambulatory care pharmacists to determine predictors of successful patient outcomes. The two groups will be compared with respect to change from baseline in quality of life and satisfaction with health care providers. A cost-benefit analysis will be undertaken to determine the impact of pharmaceutical care relative to total patient care costs. The main outcome results of the IMPROVE study are expected to be available in 1999. The IMPROVE project will be the first study of the impact of ambulatory care clinical pharmacists on patient outcomes.

Characteristics of ambulatory care clinics and pharmacists in Veterans Affairs medical centers. IMPROVE investigators. Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers.

The type and extent of ambulatory care clinical pharmaceutical services in selected Veterans Affairs medical centers (VAMCs) were studied as part of a larger project. Questionnaires were sent to the 174 VAMCs to determine the extent of clinical pharmacy activity in ambulatory care clinics, characteristics of outpatient pharmacies and clinics, and characteristics of ambulatory care pharmacists in VAMCs and to identify sites for the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) project. Fifty VAMCs responded to the survey. There were 512 ambulatory care clinics within these VAMCs. There was some pharmacist coverage in 75% of the clinics. The highest pharmacist coverage was in walk-in refill, therapeutic drug monitoring, and anticoagulation clinics. Clinical pharmacists at 68% of the VAMCs had prescribing privileges in ambulatory care clinics. Clinical pharmacists managed 29.9% of the clinics. The types of clinics most commonly managed by pharmacists were therapeutic drug monitoring, anticoagulation, walk-in refill, and lipid clinics. Nurse practitioners or physician assistants also were providing primary care in 41% of the clinics. There were 242 ambulatory care clinical pharmacy specialists practicing in the 50 VAMCs. Of these, 41.3% had three years or less of ambulatory care experience. Most pharmacists were in the clinic five days per week. A Pharm.D. degree was the highest degree obtained for 76.9%. Ambulatory care pharmaceutical services are common in VAMCs and are being provided by numerous clinical pharmacists.