A successful intervention to improve medication adherence in Black patients with hypertension: Mediation analysis of 28-site TEAM trial.

BACKGROUND: We previously reported the main effects and cost-effectiveness of a successful multifaceted Team Education and Adherence Monitoring (TEAM) intervention to improve refill adherence in Black patients with hypertension. It is important to identify the key mediators or intervention components that contributed to this intervention effect. OBJECTIVES: This study aimed to conduct a "mediation analysis" to determine which intervention components had the largest effect on refill adherence and assess patient satisfaction with pharmacy care. METHODS: A cluster-randomized trial was conducted among 576 Black patients in 28 pharmacies (14 TEAM, 14 control). TEAM participants were invited to 6 visits with a pharmacist-technician team that monitored the patient's blood pressure and used a 9-item Brief Medication Questionnaire, Brief Goal Check, and other novel tools to identify and reduce barriers to adherence in Black patients. Control participants received printed information only. Refill adherence was defined as >80% days covered (proportion of days covered) per refill records during months 7 to 12 (postintervention); potential mediators and patient satisfaction were assessed using a research questionnaire administered at month 6. A structural probit model examined 4 potential mediators that might explain intervention success. RESULTS: Of 4 potential mediators, the most important factors in explaining the improvement in refill adherence (postintervention) were greater pharmacist collaboration with patient in barrier reduction (68.5% of total indirect effect) and patient use of a pillbox (27.2% of total indirect effect). Pharmacist contact with physician and suggestion of a change in regimen did not have significant effects on adherence. TEAM participants were more likely than control participants to rate their pharmacist care as "very satisfactory" (80.2% vs. 44.2%, P < 0.001) and technician care as "very satisfactory" (81.2% vs. 47.4%, P < 0.001). CONCLUSION: Refill adherence and satisfaction can be improved in Black patients with hypertension by implementing a collaborative TEAM model with novel tools that enable community pharmacists and technicians to help identify and reduce the core barriers to adherence. Our results can be used to individualize and improve patient care and adherence outcomes in this vulnerable population.

Cost-effectiveness of Wisconsin TEAM model for improving adherence and hypertension control in black patients.

OBJECTIVES: To assess the cost-effectiveness of the 6-month Team Education and Adherence Monitoring (TEAM) intervention for black patients with hypertension in community pharmacies using prospectively collected cost data. DESIGN: Cost-effectiveness analysis of a cluster-randomized trial. SETTING: Twenty-eight chain pharmacies in 5 Wisconsin cities from December 2006 to February 2009. PARTICIPANTS: Five hundred seventy-six black patients with uncontrolled hypertension. INTERVENTION: Pharmacists and pharmacy technicians using novel tools for improving adherence and feedback to patients and physicians as compared to information-only control group. MAIN OUTCOME MEASURES: Incremental cost analysis of variable costs from the pharmacy perspective captured prospectively at the participant level. Outcomes (effect measures) were 6-month refill adherence, changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), and proportion of patients achieving blood pressure (BP) control. RESULTS: Mean cost of intervention personnel time and tools was $104.8 ± $45.2. Incremental variable costs per millimeter of mercury decrease in SBP and DBP were $22.2 ± 16.3 and $66.0 ± 228.4, respectively. The cost of helping 1 more person achieve the BP goal (<140/90 mm Hg) was $665.2 ± 265.2; the cost of helping 1 more person achieve good refill adherence was $463.3 ± 110.7. Prescription drug costs were higher for the TEAM group ($392.8 [SD = 396.3] versus $307.0 [SD = 295.2]; P = 0.02). The startup cost for pharmacy furniture, equipment, and privacy screen was $168 per pharmacy. CONCLUSION: Our randomized, practice-based intervention demonstrates that community pharmacists can implement a cost-effective intervention to improve hypertension control in blacks. This approach imposes a nominal expense at the pharmacy level that can be integrated into the ongoing pharmacist-patient relationship, and can enhance clinical and behavioral outcomes.

Improving refill adherence and hypertension control in black patients: Wisconsin TEAM trial.

OBJECTIVE: To assess the effectiveness and sustainability of a 6-month Team Education and Adherence Monitoring (TEAM) intervention for black patients with hypertension in community chain pharmacies. DESIGN: Cluster randomized trial. SETTING: 28 chain pharmacies (14 TEAM and 14 control) in five Wisconsin cities from December 2006 to February 2009. PARTICIPANTS: 576 black patients with hypertension. INTERVENTION: Trained pharmacist-technician teams implemented a 6-month intervention using scheduled visits, Brief Medication Questionnaires (BMQs), and novel toolkits for facilitating medication adherence and pharmacist feedback to patients and physicians. Control participants received patient information only. MAIN OUTCOME MEASURES: Refill adherence (≥80% days covered) and changes in systolic blood pressure (SBP), diastolic blood pressure, and blood pressure control using blinded assessments at 6 and 12 months. RESULTS: At baseline, all patients had blood pressure of 140/90 mm Hg or more. Of those eligible, 79% activated the intervention (mean 4.25 visits). Compared with control participants at 6 months, TEAM participants achieved greater improvements in refill adherence (60% vs. 34%, P < 0.001), SBP (-12.62 vs. -5.31 mm Hg, P < 0.001), and blood pressure control (50% vs. 36%, P = 0.01). Six months after intervention discontinuation, TEAM participants showed sustained improvements in refill adherence ( P < 0.001) and SBP ( P = 0.004), though the difference in blood pressure control was not significant ( P < 0.05) compared with control participants. Analysis of intervention fidelity showed that patients who received the full intervention during months 1 through 6 achieved significantly greater 6- and 12-month improvements in refill adherence and blood pressure control compared with control participants. CONCLUSION: A team-based intervention involving community chain pharmacists, pharmacy technicians, and novel toolkits led to significant and sustained improvements in refill adherence and SBP in black patients with hypertension.

The Team Education and Adherence Monitoring (TEAM) trial: pharmacy interventions to improve hypertension control in blacks.

Recent studies suggest that involving pharmacists is an effective strategy for improving patient adherence and blood pressure (BP) control. To date, few controlled studies have tested the cost-effectiveness of specific models for improving patient adherence and BP control in community pharmacies, where most Americans obtain prescriptions. We hypothesized that a team model of adherence monitoring and intervention in corporately owned community pharmacies can improve patient adherence, prescribing, and BP control among hypertensive black patients. The Team Education and Adherence Monitoring (TEAM) Trial is a randomized controlled trial testing a multistep intervention for improving adherence monitoring and intervention in 28 corporately owned community pharmacies. Patients in the 14 control pharmacies received "usual care," and patients in the 14 intervention pharmacies received TEAM Care by trained pharmacists and pharmacy technicians working with patients and physicians. Data collectors screened 1250 patients and enrolled 597 hypertensive black patients. The primary end points were the proportion of patients achieving BP control and reductions in systolic and diastolic BP measured after 6 and 12 months. Secondary end points were changes in adherence monitoring and intervention, patient adherence and barriers to adherence, prescribing, and cost-effectiveness. Researchers also will examine potential covariates and barriers to change. Involving pharmacists is a potentially powerful means of improving BP control in blacks. Pharmacists are in an excellent position to monitor patients between clinic visits and to provide useful information to patients and physicians.

Relationships between multiple self-reported nonadherence measures and pharmacy records.

BACKGROUND: Nonadherence is a momentous problem that confounds optimal medication therapy outcomes. Measuring nonadherence presents a number of methodological conundrums. Pharmacists and other health practitioners might benefit from a simple tool for measuring adherence that correlates well with other, more systematic methods. OBJECTIVES: To determine (1) the concordance between monthly oral 7-day self-reported nonadherence estimates and a written 7-day self-reported estimate of nonadherence at 3 months, (2) the concordance between oral and written self-reported nonadherence measures and pharmacy records, and (3) the extent to which oral and written self-reported nonadherence measures predict current and future medication nonadherence. METHODS: Recruitment involved 8 Wisconsin community pharmacies within a large managed care organization (MCO) and 63 patients with new antidepressant prescriptions. Oral and written self-report measures were modified from the Brief Medication Questionnaire. Pharmacy records were obtained from the pharmacies and MCO. RESULTS: Oral self-reported nonadherence estimates during weeks 4, 8, and 12 were significantly correlated with written self-reported nonadherence at week 12 (P< or =.05, week 4; P< or =.01, week 8; and P< or =.001, week 12). Oral self-reported nonadherence during weeks 8 and 12 was significantly correlated with and predictive of adherence measured via pharmacy records from months 1 to 6 (P< or =.05). Oral self-reported nonadherence at week 4 was significantly correlated to nonadherence from months 1 to 6 but only predictive of future nonadherence from months 1 to 3. Written self-report of nonadherence at week 12 was significantly correlated with and predictive of nonadherence from months 1 to 6 (P< or =.001). CONCLUSIONS: Oral and written self-report measures have moderate to strong concordance with pharmacy records. Both self-report methods are significant predictors of medication nonadherence over 6 months. This study highlights the strong relationship between simple oral questions about medication use and current and future nonadherence. Such brief questions help identify sources of nonadherence and trigger appropriate interventions.

Improving patient feedback about and outcomes with antidepressant treatment: a study in eight community pharmacies.

OBJECTIVE: To determine (1) whether telephone follow-up using a standardized telemonitoring tool can influence the nature and extent to which antidepressant users provide feedback to pharmacists, (2) whether patient characteristics are associated with the extent of patient feedback, and (3) how patient feedback affects subsequent outcomes after controlling for patient characteristics. DESIGN: Randomized, controlled, experimental design. SETTING: Eight Wisconsin community pharmacies within a large managed care organization. PATIENTS: 60 patients presenting new antidepressant prescriptions. INTERVENTIONS: Three monthly telephone calls from pharmacists providing structured education and monitoring. MAIN OUTCOME MEASURES: Frequency of patient feedback to pharmacists, antidepressant knowledge, beliefs, percentage of missed doses, depression symptom scores, and perceptions of progress. RESULTS: Compared with usual care patients (n=32), pharmacist-guided education and monitoring (PGEM) patients (n=28) provided significantly more feedback to pharmacists regarding different aspects of their antidepressant therapy even after controlling for patient characteristics. Regression results also showed that patient feedback was significantly associated with greater antidepressant knowledge, positive antidepressant beliefs, and perceptions of progress after 3 months. Patient feedback was unrelated to nonadherence and depressive symptoms. CONCLUSION: Structured education and monitoring by pharmacists significantly improves the level of patient feedback to pharmacists, and such feedback may help pharmacists identify and address their patients' misconceptions, concerns, and progress with antidepressant therapy.

Expert and consumer evaluation of patient medication leaflets provided in U.S. pharmacies.

OBJECTIVE: Evaluate the distribution and quality of patient medication leaflets provided in U.S. pharmacies. DESIGN: Observational. SETTING: United States. PARTICIPANTS: 384 randomly selected community pharmacies in 44 states. INTERVENTIONS: Professional shoppers (acting as patients) presented four new prescriptions to study pharmacies. MAIN OUTCOME MEASURES: Medication leaflets obtained by shoppers were evaluated by expert and consumer raters using criteria specified in federal law mandating distribution of useful written information to 95% of individuals receiving new prescriptions by 2006. RESULTS: Leaflets were provided by pharmacies with 89% of 1,536 prescriptions presented by professional shoppers posing as patients. Leaflet quality varied: 95% of leaflets received high ratings on accuracy, but only 19% received high ratings on the specificity of directions. Fewer than 10% of all leaflets met quality criteria regarding contraindications, precautions, and how to avoid harm. One fourth of all leaflets had poor print size, according to the shoppers. CONCLUSION: Additional efforts are needed to meet federally mandated information distribution and quality goals by 2006.

Pharmacist telemonitoring of antidepressant use: effects on pharmacist-patient collaboration.

OBJECTIVE: To explore the impact of telephone-based education and monitoring by community pharmacists on multiple outcomes of pharmacist-patient collaboration. DESIGN: A randomized, controlled, unblinded, mixed experimental design. SETTING: Eight Wisconsin community pharmacies within a large managed care organization. PATIENTS: A total of 63 patients presenting new antidepressant prescriptions to their community pharmacies. INTERVENTIONS: Patients were randomized to receive either three monthly telephone calls from pharmacists providing pharmacist-guided education and monitoring (PGEM) or usual pharmacist's care. Usual care is defined as that education and monitoring which pharmacists may typically provide patients at the study pharmacies. MAIN OUTCOME MEASURES: Patient's frequency of feedback with the pharmacist, antidepressant knowledge, antidepressant beliefs, antidepressant adherence at 3 and 6 months, improvement in depression symptoms, and orientation toward treatment progress. RESULTS: Of the 60 patients who completed the study, 28 received PGEM and 32 received usual pharmacist's care. Results showed that PGEM had a significant and positive effect on patient feedback, knowledge, medication beliefs, and perceptions of progress. There were no significant group differences in patient adherence or symptoms at 3 months; however, PGEM patients who completed the protocol missed fewer doses than did the usual care group at 6 months (P < or = .05). CONCLUSION: Antidepressant telemonitoring by community pharmacists can significantly and positively affect patient feedback and collaboration with pharmacists. Longer-term studies with larger samples are needed to assess the generalizability of findings. Future research also needs to explore additional ways to improve clinical outcomes.

Patient counseling provided in community pharmacies: effects of state regulation, pharmacist age, and busyness.

OBJECTIVE: To describe the nature and extent of patient counseling in community pharmacies and determine whether current counseling practices are influenced by pharmacist and pharmacy characteristics and variations in state regulation of patient counseling. DESIGN: Observational, cross-sectional study. SETTING: 306 community pharmacies in eight states. PARTICIPANTS: Trained shoppers (acting as patients). INTERVENTIONS: Three new prescriptions were presented in each pharmacy, and regression techniques were used to analyze the effects of pharmacist age, pharmacy type, and busyness; whether written information was provided; and "intensity" of a state's patient counseling regulation as measured by its scope, stringency, and duration. MAIN OUTCOME MEASURES: Whether any or all of these events occurred: pharmacist talked with shopper, oral drug information was given, oral risk information was given, and/or questions were asked to assess shopper understanding; number of informational items mentioned (range 0-7) was also recorded. RESULTS: About 63% of the shoppers were given oral drug information (mean = 2.3 items). Shoppers with a younger responsible pharmacist were more likely than other shoppers to receive risk information, a higher number of informational items, and assessment of understanding. While pharmacy type was unrelated to counseling, busyness reduced the odds of any pharmacist talk, oral information-giving, and assessment of understanding. Counseling practices varied significantly according to the intensity of a state's counseling regulation, with frequency of any information provision climbing from 40% to 94% as states' counseling regulations increased in intensity. More intensive regulations also increased the likelihood of any pharmacist talk, any provision of risk information, any assessment of shopper understanding, and amount of oral information given. CONCLUSION: Counseling varied significantly according to intensity of state regulation, pharmacy busyness, and age of responsible pharmacist. These results present important challenges to state boards of pharmacy, pharmacy associations, managers, and individual practitioners who are in a position to improve this important element of patient care.

Evaluation of written prescription information provided in community pharmacies: a study in eight states.

OBJECTIVES: To develop three tools for assessing the quality of written information provided with new prescriptions in community pharmacies and to identify pharmacy, pharmacist, and patient characteristics associated with the dissemination and quality of that information. DESIGN: Observational study. Regression techniques were used to analyze the influence of pharmacy, pharmacist, and shopper (acting as patient) characteristics on outcome measures. PARTICIPANTS: Trained shoppers (acting as patients) visited 306 randomly selected pharmacies in 8 states. Each shopper presented three prescriptions, answered questions according to a standard scenario, accepted the information offered, and paid for the prescriptions. MAIN OUTCOME MEASURES: Percentage of shoppers receiving any written information; quality of written information as judged by an expert panel using explicit criteria. RESULTS: Shoppers received an information leaflet with 87% of the 918 prescriptions dispensed. Although most leaflets provided unbiased information, leaflet length and quality of information varied greatly. A majority of leaflets did not include adequate information about contraindications, precautions, and how to avoid harm. Shoppers were more likely to receive leaflets in chain pharmacies and pharmacies with more staff. Information quality also was higher in chain pharmacies. Shopper and pharmacist demographic characteristics were unrelated to the level or quality of written information after controlling for other factors. CONCLUSION: The provision of patient leaflets is becoming a routine practice in the states studied. However, most leaflets do not meet quality criteria. It is important for pharmacists to become familiar with criteria for evaluating these leaflets and to take necessary action to improve their quality.

Challenges to the use of nonpharmacologic interventions in nursing homes.

The Nursing Home Reform Act, part of the Omnibus Budget Reconciliation Act of 1987, stated that nursing homes should try nonpharmacologic interventions before resorting to pharmacologic agents when addressing problem behaviors among residents. Since that time, the use of pharmacologic agents has decreased, but there is little evidence to suggest that the use of nonpharmacologic interventions has increased. Psychosocial models describe problem behaviors as complex phenomena that require individualized strategies based on a resident's unique characteristics. Categories of intervention include social contact, behavior therapy, staff training, structured activities, environmental interventions, and a combination of therapies. This article discusses internal barriers to the use of nonpharmacologic interventions based on the Porras stream organization model: organizing arrangements, social factors, technology, and physical setting. Also, external barriers related to the regulatory, legal, and economic sectors are discussed. The authors offer recommendations for overcoming these barriers.

Effects of residents' depression, sleep, and demand for medication on benzodiazepine use in nursing homes.

OBJECTIVE: This study sought to identify risk factors associated with the prescription and use of benzodiazepines in nursing homes and to assess the prevalence and determinants of demand for benzodiazepines among nursing home residents. METHODS: Data were available for 2,060 residents who had participated in a previous study of use of medications in 18 randomly selected nursing homes in Wisconsin between 1986 and 1989. Data sources included nursing home and pharmacy records; nurses' assessments of residents' behavior, pain, sleep, and demand for medication; and researchers' observations of resident requests for medication. Measures of benzodiazepine use included benzodiazepine prescriptions, prevalence and extent of as-needed drug use, and chronic use as defined by Health Care Financing Administration guidelines. RESULTS: A quarter of the residents received prescriptions for benzodiazepines. Of these, 71 percent received prescriptions to aid sleep or to be taken at bedtime; 32 percent used benzodiazepines for a longer period than recommended; and 26 percent requested medication. Logistic regression analysis showed that residents with depression, pain, or sleep problems were more likely to have received benzodiazepines and to have requested medication. Chronic use was significantly higher among residents with depression, sleep problems, or multiple benzodiazepine regimens and among those who requested medication. Demand and sleep problems also were associated with higher rates of any as-needed use and with higher numbers of as-needed doses used. CONCLUSIONS: Efforts to improve benzodiazepine use in nursing homes must address the need for better assessment and management of depression, sleep, pain, and residents' demand for these medications.

Nurse-physician communication and quality of drug use in Swedish nursing homes.

The objective was to explore the impact of the quality of nurse-physician communication on the quality of psychotropic drug use in Swedish nursing homes, while controlling for resident mix and other nursing home characteristics. Data were collected from a sample of 36 Swedish nursing homes providing care for 1645 residents. Drug use data, along with residents' demographic characteristics, were obtained from residents' medication administration lists. Ward nurses reported other residents' characteristics (e.g. diagnosis and frequency of behavioral problems), and facility characteristics were obtained from head nurses. The quality of drug use was assessed and cross-sectional relationships among study variables were compared. Outcome measures included two drug use quality scores reflecting selection of drug and polymedicine. To assess behavioral problems, a list of the most commonly observed problems was created through a number of steps, including focus groups in the target population. Furthermore, a valid and reliable scale for assessing communication quality was developed. This measure was included in a survey administrated to nurses in the 36 facilities. There was a remarkable variation in the quality of drug use according to the two drug measures. As predicted, the quality of drug use was positively associated with the quality of nurse-physician communication and with regular multidisciplinary team discussions addressing drug therapy and negatively associated with prevalence of behavioral disturbances among residents. Facility size, level of staffing, resident's diagnostic mix, and demographic mix were unrelated to the two drug quality measures. Future efforts to improve the quality of drug use in long term facilities should consider ways of improving communication skills and communication routines among health care professionals.

Using alternative methodologies for evaluating patient medication leaflets.

A variety of direct and indirect methods have been used to evaluate written medication information; however, no published research has validated assessment tools or presented direct consumer assessment of patient information leaflets (PILs) provided in US community pharmacy (CP). We report on two new instruments: the medication information design assessment scale (MIDAS), an indirect measure of design quality administered by the investigators, and the consumer information rating form (CIRF), a direct measure of comprehensibility, utility, and overall design quality applied by a consumer panel. These were used to assess two types of PILs: 36 CP-PILs obtained from community pharmacies and 3 Model-PILs incorporating recommended design characteristics. The validity of the MIDAS was demonstrated in two ways. First, as predicted, the Model-PILs were rated more positively by consumers. We also found a significant positive correlation between the number of design criteria incorporated in a CP-PIL (as measured by the MIDAS score) and the consumers rating of design quality (CIRF). In conclusion, we confirmed the importance of design characteristics in the production of written medication information and have also developed and validated two easy-to-use tools for the assessment of written medication information.

Effects of pharmacist monitoring on patient satisfaction with antidepressant medication therapy.

OBJECTIVE: To examine the effects of pharmacist monitoring on patient satisfaction with and adherence to antidepressant medication therapy. DESIGN: In this prospective field study, we interviewed patients starting an antidepressant after a new prescription was dispensed and again 2 months later. The first interview assessed patients' characteristics, antidepressant medication history, knowledge of antidepresant medications and their use, and beliefs about antidepressant medications. The second interview focused on pharmacist monitoring behavior and satisfaction with the antidepressant medication. SETTING AND PARTICIPANTS: From 23 community pharmacies, we enrolled 100 patients, 59 of whom were taking an antidepressant for the first time. MAIN OUTCOME MEASURES: Patient satisfaction with and reported adherence to their antidepressant medication regimen. RESULTS: Pharmacist monitoring of patients' antidepressant medication use varied. More than 70% of patients reported that pharmacists asked about medication concerns; 53% and 54% of patients, respectively, said pharmacists encouraged their questions and listened to their concerns; and 32% found pharmacists helpful in solving problems related to the antidepressant. Fifty-seven percent of patients reported feeling better a lot of the time since taking the antidepressant, 40% said the antidepressant did not bother them, and 83% reported missing doses, adding doses, or stopping the antidepressant during the study period. Initial beliefs about antidepressants were a strong predictor of patient outcomes. Pharmacist monitoring was predictive of satisfaction and adherence for individuals taking an antidepressant for the first time. CONCLUSION: Pharmacists can play a critical role in monitoring medication concerns at the beginning of use, allowing for problem solving, reinforcement, and greater patient satisfaction with and adherence to medication therapy. Obstacles to effective pharmacist monitoring and follow-up need to be identified and addressed in future improvement efforts.