A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.

PURPOSE: Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease (CVD), a leading cause of death in the United States. Despite clinical practice guidelines aimed at facilitating LDL-C control, many Veterans do not achieve guideline-recommended LDL-C levels. METHODS: We describe a study focused on VA healthcare system users at risk for CVD (i.e., LDL-C level >130 mg/dl and/or <80% cholesterol pill refill adherence in the last 12 months). We are conducting a two and a half year randomized controlled trial (i.e., intervention administered over 12 months) among Veterans with uncontrolled cholesterol receiving care at select VA-affiliated primary care clinics in North Carolina. We anticipate enrolling 250 diverse patients (10% women; 40% African American). Patients are randomized to an educational control group or intervention group. Intervention group participants' medication is provided in special blister packaging labeled for daily use that includes reminders; MeadWestvaco Corporation's pre-filled DosePak® contains standard doses of statins in accordance with the existing prescriptions. CONCLUSIONS: Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence. Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can: 1) improve medication adherence; 2) improve patients' LDL-C levels; 3) be well received by patients and providers; and 4) provide a cost effective solution to improve medication adherence.

The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes.

BACKGROUND: Cardiovascular disease (CVD) and diabetes account for one-third of the mortality difference between African American and white patients. We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes. METHODS: We randomized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention. The 12-month intervention provided monthly self-management support and quarterly medication management facilitation. Coprimary outcomes were changes in systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) over 12 months. We estimated between-intervention group differences over time using linear mixed-effects models. The secondary outcome was self-reported medication adherence. RESULTS: The sample was 72% female; 49% had low health literacy, and 37% had annual income <$10,000. Model-based estimates for mean baseline SBP, HbA1c, and LDL-C were 136.8 mm Hg (95% CI 135.0-138.6), 8.0% (95% CI 7.8-8.2), and 99.1 mg/dL (95% CI 94.7-103.5), respectively. Intervention patients received 9.9 (SD 3.0) intervention calls on average. Primary providers replied to 76% of nurse medication management facilitation contacts, 18% of these resulted in medication changes. There were no between-group differences over time for SBP (P = .11), HbA1c (P = .66), or LDL-C (P = .79). Intervention patients were more likely than those receiving usual care to report improved medication adherence (odds ratio 4.4, 95% CI 1.8-10.6, P = .0008), but adherent patients did not exhibit relative improvement in primary outcomes. CONCLUSIONS: This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes. Further research is needed to determine how to maximally impact CVD risk factors in African American patients.

The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: study design and methodology.

BACKGROUND: Cardiovascular disease (CVD) and diabetes account for over one third of the mortality difference between African Americans and white patients. The increased CVD risk in African Americans is due in large part to the clustering of multiple CVD risk factors. OBJECTIVES: The current study is aimed at improving CVD outcomes in African-American adults with diabetes by addressing the modifiable risk factors of systolic blood pressure , glycosylated hemoglobin, and low-density lipoprotein cholesterol. METHODS: A sample of African American patients with diabetes (N = 400) will receive written education material at baseline and be randomized to one of 2 arms: (1) usual primary care or (2) nurse-administered disease-management intervention combining patient self-management support and provider medication management. The nurse administered intervention is delivered monthly over the telephone. The nurses also interacts with the primary care providers at 3, 6, and 9 months to provide concise patient updates and facilitate changes in medical management. All patients are followed for 12 months after enrollment. The primary outcomes are change in glycosylated hemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol over 12-months. Secondary outcomes include change in overall cardiovascular risk, aspirin use, and health behaviors. CONCLUSION: Given the continued racial disparities in CVD, the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients.

Behind closed doors: management of patient expectations in primary care practices.

BACKGROUND: Managed care restrictions on resource use may affect communication between patients and health care professionals. METHODS: To characterize negotiations between primary care physicians and patients with expectations for new medications, tests, or referrals, this observational study combined survey data with audiotape recordings of clinical encounters. Fifty-five physicians from 20 randomly selected primary care practices in a managed care network and 211 patients who voiced specific expectations in a previsit survey were included. From the recorded clinic visits we determined modes of negotiation of patient expectations and requests. From the surveys we determined patient previsit expectations, postvisit fulfillment of expectations, satisfaction, and trust. RESULTS: Two-hundred fifty-six self-reported expectations were captured in 200 audiotape-recorded encounters. Of the previsit expectations, 97.3% were discussed during the encounter. Expectations were expressed by direct patient request (40.6%), mentioning of symptoms related to request (29.7%), or physician-initiated discussion (27.0%). Most expectations were met (66.8%); physicians suggested an alternative 21.6% of the time. Expectations for medications and tests were met more frequently than expectations for referrals (75.6% and 71.4% vs 40.8%). Patient satisfaction and trust remained high regardless of whether expectations were met. Physicians reported that they would not have ordered 62 (44.9%) of 138 requests had the patients not directly asked, and they were uncomfortable filling 8 requests (12.9%). CONCLUSIONS: Previsit expectations for medications, tests, or referrals were discussed at the visit, and physicians met or offered alternatives for nearly 90%. Patients generally received what they asked for and altered physician behavior nearly half of the time.

Studying communication in oncologist-patient encounters: the SCOPE Trial.

STUDY OBJECTIVE: Most oncologists have not received adequate training in physician-patient communication, and existing effective courses tend to be time and resource intensive. We are developing and testing a tailored CD-ROM educational intervention that includes feedback on oncologists' own audio-recorded conversations with their advanced cancer patients. In this report, we describe the study methods and identify challenges to implementation and how these were overcome. STUDY DESIGN: A three-phase, randomized, controlled trial. In Phase 1, we audio-recorded oncologist-patient clinic encounters. In Phase 2, oncologists were randomly assigned to a communication CD-ROM intervention or control. Phase 3 consisted of audio-recording all participating oncologists conversing with a new sample of patients, two to 12 months after the intervention, to assess its effectiveness. SETTING: Oncology clinics at Duke University Medical Center (DUMC) and the Durham Veterans Affairs Medical Center (DVAMC) in Durham, NC, and the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, PA. PARTICIPANTS: Medical, radiation and gynecological oncologists and their patients with advanced cancer. INTERVENTION: A tailored CD-ROM that contains an interactive educational interface with reference materials and video-clips of model conversations, along with the oncologists' own Phase 1 audio-recorded conversations. CONCLUSION: We present challenges and solutions to oncologist recruitment, identifying appropriate patients with advanced cancer, adapting to clinic flow, and developing a self-administered communications intervention.