Tool to improve patient-provider interactions in adult primary care: Randomized controlled pilot study.

OBJECTIVE: To assess whether an intervention to help patients prioritize goals for their visit would improve patient-provider communication and clinical outcomes. DESIGN: Randomized controlled pilot study. SETTING: Primary care clinic. PARTICIPANTS: There were 120 adult hypertensive patients enrolled. INTERVENTION: Patients were randomized to receive either usual care or a previsit patient activation card developed through a series of focus groups that prompted patients to articulate their needs and set priorities for their clinic visit. Encounters were audiorecorded, transcribed, and assessed using duplicate ratings of patient activation and decision making. MAIN OUTCOME MEASURES: The primary outcome was change in medication adherence as measured by pill count at 4 and 12 weeks after the initial visit. Secondary outcomes evaluated patient-provider interaction quality (patient satisfaction, patient activation, shared decision making, patient trust, and physicians' perceived difficulty of the encounter), functional status, and blood pressure control. RESULTS: Of the 120 enrolled patients, 106 completed the baseline visit (mean age of 66 years, 53% women, 57% Black, 36% White). Participants had multiple comorbidities (median number of medications = 8). During the visit, there was greater patient activation in the intervention arm than in the control arm (4.4 vs 3.8, P = .047; ratings were based on a scale from 1 to 10). However, after the visit there were no differences in medication adherence (4 weeks: 45.8% vs 49.5%; 12 weeks: 49.4% vs 51.1%), blood pressure control (4 weeks: 133/78 mm Hg vs 131/77 mm Hg; 12 weeks: 129/77 mm Hg vs 129/76 mm Hg), or encounter satisfaction (78.6% vs 73.8% fully satisfied; P = .63). There were also no differences in shared decision making, patients' trust, or perceived difficulty of the encounter. CONCLUSION: A single previsit tool designed to prompt patients to set a prioritized agenda improved patient activation during the visit, but did not affect the quality of the interaction or postvisit patient-centred outcomes.

Ten lessons learned from conducting an adherence intervention trial.

Clinical practice research provides a unique opportunity to care for a diverse patient population in various health care system settings. Federal study of Adherence to Medications in the Elderly (FAME) was the first prospective observational and randomized controlled trial to implement effective strategies to enhance medication adherence and health outcomes in older patients using polypharmacy. Ten lessons learned from conducting this adherence intervention trial are described: (1) Link the trial to existing clinical work, (2) Begin with a thorough understanding of medication adherence, (3) Ensure that trial highlights individualized intervention, (4) Tailor inclusion criteria and study duration to target population, (5) Employ a range of outcomes linked to meaningful clinical effects, (6) Win the support of the multidisciplinary team and the administration, (7) Promote team work, (8) Consider the potential limitations, (9) Seize the grant opportunities, and (10) Share the findings.

Relationship between glycemic status and progression of carotid intima-media thickness during treatment with combined statin and extended-release niacin in ARBITER 2.

BACKGROUND: We previously reported in a placebo-controlled study that extended-release niacin slowed the progression of carotid atherosclerosis when added to statin monotherapy. This analysis examines the relationship between glycemic status and the effects of niacin on common carotid intima-media thickness (CIMT) and HDL cholesterol. METHODS: Post-hoc, subgroup analysis of ARBITER 2, a randomized, placebo-controlled trial of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease. The primary analysis was a comparison of the primary endpoint, the change in CIMT, between participants with either normal glycemic status, diabetes mellitus (DM) or the metabolic syndrome (MS). RESULTS: Baseline cardiovascular risk variables were significantly worse in those with abnormal glycemic status, particularly among subjects with MS. Niacin increased HDL-C to a similar degree (approximately 20%) across normals, DM and MS. Placebo-treated patients had the greatest CIMT progression, regardless of glycemic status. The lowest progression rate was observed in niacin treated patients with normal glycemic status. Among all niacin treated subjects, there was a significant linear relationship between change in CIMT and change in HDL-C (r = -0.16; p = 0.05), which was of similar magnitude in subgroups with normal glycemic status (r = -0.23; p = 0.08) and DM (r = -0.22; p = 0.17). In those with MS, there was no relationship between changes in HDL and CIMT, (r = 0.11; p = 0.44), whereas blood glucose was positive correlated to change in CIMT (r = 0.30; p = 0.04). In multivariable linear models controlling for MS characteristics and blood glucose changes, only the change in HDL independently predicted change in CIMT. CONCLUSIONS: During niacin treatment, increases in HDL-C are related to changes in CIMT in the setting of both normal glycemic status and diabetes mellitus.

How should we measure medication adherence in clinical trials and practice?

OBJECTIVE: To determine if simple adherence measures, such as twenty-four hour recall and refill history, are accurate for routine use, compared to more time-consuming measures such as pill counts. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Walter Reed Army Medical Center, a tertiary medical center in Washington. PATIENTS: Men and women >30 years old with known coronary heart disease and taking a statin medication. INTERVENTION: Clinical pharmacists met with patients for adherence assessments. MAIN OUTCOME MEASURES: Adherence was measured by pill counts, twenty-four hour recall by patient, and refill history per computer record. Temporal changes in these adherence measures were assessed using general linear models for repeated measures. RESULTS: Adherence was consistently greater for the experimental agent than for the statin therapy (n = 148). Mean pill count adherence for statin drug was 78.7 +/- 25.2% compared to 93.5 +/- 11.6% (P < 0.001) for the study agent. Refill history and twenty-four hour recall inaccurately measured adherence when compared to pill counts. Adherence, as determined by pill count, for both experimental (P = 0.029) and statin therapy (P = 0.015) showed significant variability across time in general linear models. Neither refill history nor twenty-four hour recall was sensitive to temporal changes. CONCLUSIONS: Twenty-four hour recall and refill history inaccurately measure medication adherence for both clinical trial and clinical practice pharmacotherapies. Further, these measures are insensitive to changes in adherence. For a single or multiple assessments across time, pill count more accurately measures medication adherence. Pill count should be the standard for monitoring medication adherence for both clinical trials and clinical practice.

Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial.

CONTEXT: Poor medication adherence diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications, placing them at increased risk for nonadherence. OBJECTIVE: To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C). DESIGN, SETTING, AND PATIENTS: A multiphase, prospective study with an observational phase and a randomized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications. The study was conducted from June 2004 to August 2006. INTERVENTION: After a 2-month run-in phase (measurement of baseline adherence, BP, and LDL-C), patients entered a 6-month intervention phase (standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific packs). Following the intervention phase, patients were randomized to continued pharmacy care vs usual care for an additional 6 months. MAIN OUTCOME MEASURES: Primary end point of the observation phase was change in the proportion of pills taken vs baseline; secondary end points were the associated changes in BP and LDL-C. Primary end point of the randomization phase was the between-group comparison of medication persistence. RESULTS: A total of 200 elderly patients (77.1% men; mean [SD] age, 78 [8.3] years), taking a mean (SD) of 9 (3) chronic medications were enrolled. Coronary risk factors included drug-treated hypertension in 184 patients (91.5%) and drug-treated hyperlipidemia in 162 (80.6%). Mean (SD) baseline medication adherence was 61.2% (13.5%). After 6 months of intervention, medication adherence increased to 96.9% (5.2%; P<.001) and was associated with significant improvements in systolic BP (133.2 [14.9] to 129.9 [16.0] mm Hg; P = .02) and LDL-C (91.7 [26.1] to 86.8 [23.4] mg/dL; P = .001). Six months after randomization, the persistence of medication adherence decreased to 69.1% (16.4%) among those patients assigned to usual care, whereas it was sustained at 95.5% (7.7%) in pharmacy care (P<.001). This was associated with significant reductions in systolic BP in the pharmacy care group (-6.9 mm Hg; 95% CI, -10.7 to -3.1 mm Hg) vs the usual care group (-1.0 mm Hg; 95% CI, -5.9 to 3.9 mm Hg; P = .04), but no significant between-group differences in LDL-C levels or reductions. CONCLUSIONS: A pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00393419

Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2: a double-blind, placebo-controlled study of extended-release niacin on atherosclerosis progression in secondary prevention patients treated with statins.

BACKGROUND: Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown. METHODS AND RESULTS: This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CIMT (0.884+/-0.234 mm), low-density lipoprotein cholesterol (89+/-20 mg/dL), and HDL-C (40+/-7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044+/-0.100 mm; P<0.001) and was unchanged in the niacin group (0.014+/-0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P=0.20). CONCLUSIONS: The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.

Implementation of a therapeutic-interchange clinic for HMG-CoA reductase inhibitors.

A therapeutic-interchange clinic for statins is described. In 1999, the Department of Defense mandated the use of cerivastatin and simvastatin as the formulary statins in all military health care facilities by April 2000. Cerivastatin was the preferred agent; the goal was to use this agent in 60-65% of all patients. Walter Reed Army Medical Center developed a voluntary therapeutic-interchange clinic for patients receiving statins. Goals included facilitating the rapid switching of patients to the formulary statins, maximizing the use of the preferred agent, maintaining or improving lipid control, monitoring safety, determining costs, educating patients about their treatment, and documenting satisfaction with the clinic. Written educational materials were prepared, an algorithm for statin conversion was created, and laboratory tests were performed, among other measures. Between January and April 2000, 1356 patients were seen by the therapeutic-interchange clinic; of these, 942 agreed to have the efficacy and safety of their therapy monitored by the clinic. Before the formulary change, the most commonly prescribed statins were atorvastatin (44% of patients) and pravastatin (42%). Under the conversion policy, 96% of patients received cerivastatin and 4% simvastatin. The percentage of patients achieving their targeted low-density-lipoprotein cholesterol concentration increased from 65% to 75%. The policy saved an average of $115 per patient in the first year. Most patients were satisfied with the clinic, but only 36% of providers were satisfied. Cerivastatin was withdrawn from the market in August 2001; simvastatin became the only formulary statin. A therapeutic-interchange clinic at a military medical center provided an efficient means of switching a large number of patients to alternative statin therapy, monitoring the outcomes, and individualizing patient care.