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Evidence-based health benefits management: strategies to optimize antiretroviral medication adherence and outcomes in HIV/AIDS.

OBJECTIVE: To review how evidence-based principles can be applied to benefit design, specialty network management, and medication therapy management to successfully manage pharmaceutical benefits for patients infected with human immunodeficiency virus (HIV). SUMMARY: The most critical barrier to successfully managing HIV disease is suboptimal patient adherence to antiretroviral therapy. Managing HIV infection is unique in that the risk of treatment failure increases remarkably with even relatively minor lapses in patient adherence. The incremental cost of HIV treatment failure has been approximated at $26,000 per patient per year. Treatment failure, of course, also drives mortality related to HIV and acquired immunodeficiency syndrome (AIDS). Benefit design, specialty medication management strategies, and care management programs can be integrated to deliver high-quality, efficient care that optimizes clinical outcomes for populations of HIV-infected individuals. CONCLUSION: Managed care programs can be structured to provide HIV care that allows optimal patient adherence and clinical outcomes.

Antiretroviral Therapy, Highly Active↗

Assessing medication adherence by pill count and electronic monitoring in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study.

The Medication Event Monitoring System (MEMS), an electronic monitor which records the date and time of bottle cap openings, and pill counts were used to assess patterns of adherence for the primary antihypertensive drug in the African American Study of Kidney Disease and Hypertension Pilot Study (AASK). Blacks with hypertension and moderately reduced renal function were randomized to one of two levels of blood pressure control and to one of three antihypertensive drug regimens: primary therapy with a calcium channel blocker, an angiotension converting enzyme inhibitor, or a beta-blocker. Of the 94 participants in AASK, 91 had MEMS recordings and pill counts for 313 regularly scheduled monthly follow-up visits. The average length of follow-up was 4.6 months. An acceptable level of adherence by pill count was achieved if 80% to 100% of the prescribed pills were not returned to the clinic. Adherence by MEMS to a once-a-day drug dosing schedule was acceptable if 80% of the time intervals between MEMS openings were within 24 +/- 6 h. Acceptable adherence by pill count was observed at 68% of the follow-up visits; MEMS indicated nonadherence at 47% of those visits. Blood pressure was within goal in 50% of the participants who were adherent by both pill count and MEMS throughout their follow-up visits, and only 14% of the participants who were identified nonadherent by one or both methods. These findings suggest that electronic monitoring is a useful adjunct to pill counts in assessing adherence to antihypertensive drugs. Feedback of electronically collected information on dosing intervals to participants and staff may enhance adherence.

Adolescent↗

Maximizing medication adherence in low-income hypertensives: a pilot study.

A pilot study was conducted to examine the association between free medication and comprehensive care on blood pressure control for 60 adults with uncontrolled essential hypertension (mean blood pressure = 157/96 mm Hg) referred from a variety of primary care clinics at a public teaching hospital. Subjects received comprehensive care, free antihypertensive medication dispensed in the clinic, and patient education regarding hypertension and medication compliance. Matched-pair t-tests revealed average drops in blood pressure of 22 mm Hg systolic and 13 mm Hg diastolic for the entire sample from baseline to 6 months post-enrollment (both P's < .001). The comprehensive hypertension management program with education and free medication was significantly related to reduced blood pressure across the 6 months of the study period.

Adult↗

Metacognition and medication adherence: how do older adults remember?

Fifty-one older adults (M age = 75.9 years, SD = 6.9) reported their use of memory strategies for taking of medication using the Prospective Memory for Medication Questionnaire. Older adults used internal strategies more often when the domain was restricted to medication taking but used external strategies more often when queried across a variety of everyday situations. Surprisingly, the hypothesis that medical factors would be the primary determinants of older adults' reports of memory strategy use and perceived adherence was not supported. Metamemorial variables of non-domain-specific memory self-efficacy and memory anxiety in everyday life were significant predictors of strategy use and perceived adherence over and above variables related to the domain of health.

Adult↗

Improving medication adherence through patient education distinguishing between appropriate and inappropriate utilization. Patient Education Study Group.

OBJECTIVE: To evaluate the effectiveness of a computer assisted educational intervention to facilitate appropriate utilization of an antiinflammatory medication (Arthrotec) and investigate the mechanism by which it produces these effects. METHODS: A double blind, multicenter, randomized, controlled trial studied patients over age 50 years with hip or knee osteoarthritis (OA). All patients (n = 252) were treated with the medication (diclofenac + misoprostol). Patients randomized to the experimental group interacted with a computer program delivering information about their disease, the medication, its intended and side effects, appropriate utilization (distinguishing between appropriate versus inappropriate continuation and discontinuation of medication), patient involvement in treatment related decision making, and communication with service providers. In the control condition, another computer program presented generic information about OA. Data were collected at pre-test, post-test, and 8 week followup. RESULTS: Appropriate utilization of the medication occurred more frequently in the experimental than the control group (p<0.029). Compared to controls, the experimental group demonstrated significant improvements in knowledge, realistic expectations of drug benefits, perceived ease of adherence, and self-efficacy (all p<0.05). There was no difference between the groups with regard to illness intrusiveness, pain, or disability, but there was a greater improvement in stiffness in the experimental group (-0.63; 95% CI -0.81 to -0.45) compared to the control group (-0.39; 95% CI -0.53 to -0.25) at a level of p = 0.04. CONCLUSION: In conditions such as OA, where patient involvement in decision making is essential to the effectiveness of care, computer assisted education focussing on appropriate vs inappropriate continuation and discontinuation of medications has the potential to improve knowledge, increase self-efficacy, maintain realistic expectations, and facilitate adherence, resulting in more beneficial clinical outcomes.

Aged↗

Social stigma concerns and HIV medication adherence.

The threat of social stigma may prevent people living with HIV from revealing their status to others and serve as a barrier to HIV treatment adherence. We evaluated the effect of such concerns on self-reported treatment adherence using a short, three-item measure among 204 people living with HIV. Overall, the mean age of participants was 40.1 years, 45% were African American, and 80% were male. People with high HIV stigma concerns were 2.5 times less likely to define and interpret the meaning of CD4 count correctly and 3.3 times more likely to be nonadherent to their medication regimen than those with low concerns. Concern over revealing HIV status was the only statistically significant, independent predictor of adherence in multivariate analysis. Clinical care directed to individuals living with HIV should therefore include considerations for patient sensitivity to social stigma, such as modifications to medication schedules and referrals for counseling prior to enrollment in antiretroviral therapies.

Adult↗

Pharmaceutical companies and health plans have a shared interest in boosting medication adherence.

Health plans and pharmaceutical companies develop adherence strategies. With only about half of all prescriptions being taken as directed, both health plans and pharmaceutical companies are getting serious about developing strategies to keep patients on track with their medications. What they're finding is that it's a complicated problem requiring patient-centric solutions.

Cooperative Behavior↗

Barriers and facilitators to antiretroviral medication adherence among patients with HIV in Chennai, India: a qualitative study.

Antiretroviral therapy (ART) for HIV is increasingly being introduced and utilized in diverse areas of the world. However, little research exists on adherence to ART in different cultural settings, particularly in developing countries such as India. This formative qualitative study examined barriers and facilitators of ART adherence among 60 (49 men, 11 women; 33 taking ART, 27 not currently taking ART) patients receiving HIV primary care at YRG CARE, a nongovernmental organization, in Chennai, India. The average participant reported becoming HIV infected through heterosexual transmission, was between 31 and 40 years old, had over ninth class standard education, was married, and generally had access to medical care; however, we obtained some qualitative data from various other risk categories. Trained ethnographers at the study site conducted in-depth interviews in the local language. These interviews were analyzed for content and ethnographic data. Almost all of the participants discussed the cost of ART as a barrier, with many reporting extended drug holidays, turning to family and/or friends, or taking drastic measures (i.e., selling family jewels, property) for financial assistance. Other barriers centered on privacy and stigma issues, such as disclosure of HIV inhibiting pill-taking and social support. Frequently discussed facilitators of adherence included perceived benefits of ART and proper adherence, perceptions about the consequences of nonadherence, and social support, if available. These data highlight the importance of reducing the cost of antiretroviral medications, involving family members in HIV care, and addressing privacy issues and stigma in counseling interventions in this setting.

Adult↗

Individualizing memory strategies to improve medication adherence.

Changes in cognitive processes are well documented among even essentially healthy community-dwelling older adults. Although these changes do not produce the level of cognitive impairment associated with dementia, they do have the capacity to influence the degree to which elderly individuals self-manage chronic conditions. This pilot investigation tested the effect of an intervention to improve remembering to take medications and tracking if medications were taken as intended. Twenty-seven older adults (age range = 67-89 years, M = 78 years) all self-managing prescribed medications had one medication electronically monitored for 8 weeks preintervention and then 8 weeks postintervention. The percentage of days the correct number of doses was taken increased from a mean of 64.5% to that of 78%. With the use of Wilcoxon's signed ranks test, this improvement in adherence is significant. When participants with dementia or mild cognitive impairment were eliminated from the analysis (n = 6), the intervention continued to improve adherence (70.6% to 86%), suggesting that many older adults have the potential to improve adherence through individualized implementation of memory strategies.

Adult↗

Aging and medical adherence: the use of automatic processes to achieve effortful things.

This research examined whether forming detailed implementation plans for achieving a goal improved older adults' adherence to a health behavior. Nondiabetic participants (N = 31) rehearsed, deliberated, or formed implementation intentions to perform home blood glucose monitoring, 4 times daily for 3 weeks. The implementation group performed tests nearly 50% more often than the 2 comparison groups. Results were not attributable to a priori differences in intentions to perform testing. Findings indicate that implementation intentions can facilitate older adults' performance of important medical self-care tasks in naturalistic settings over sustained periods of time and concur with previous research that implicates automatic cognitive processes that do not show age-related decline. These results support the utility of this technique for improving adherence to health behaviors in clinical populations.

Aged↗

Insight and adherence to medication in chronic schizophrenics.

Chronic schizophrenics are well-known for the tendency to not take medication. Clinical observation and studies indicate that insight plays a significant role in medication adherence. This study investigated the roles of insight and perceived benefits from medication by patients. Those patients who had insight, perceived benefits from medication and also perceived a relation between the 2 were more likely to take medication than those who did not have insight nor perceive benefits. A speculative model and possible methods of increasing medication adherence are suggested.

Awareness↗

Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens.

BACKGROUND: Although non-adherence to an immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTx), very few studies have examined non-adherence intervention in this context. This pilot randomized controlled trial (RCT) tested the efficacy of an educational-behavioural intervention to increase adherence in non-adherent RTx patients. We also assessed how NAH evolves over time. METHODS: Eighteen RTx non-adherent patients (age: 45.6 +/- 1.2 yr; 78.6% male) were randomly assigned to either an intervention group (IG) (n = 6) or an enhanced usual care group (EUCG) (n = 12), the latter receiving the usual clinical care. The IG received one home visit and three telephone interviews. We assessed NAH through electronic monitoring (EM) of medication intake during a nine-month period (three months intervention, six months follow-up). RESULTS: Five of 18 patients withdrew. Inclusion in the study resulted in a remarkable decrease in NAH in both groups over the first three months (IG chi(2) = 3.97, df = 1, p = 0.04; EUCG chi(2) = 3.40, df = 1, p = 0.06). The IG showed the greatest decrease in NAH after three months, although this did not reach statistical significance (at 90 d, chi(2) = 1.05, df = 1, p = 0.31). Thereafter, NAH increased gradually in both groups, reaching comparable levels at the end of the six-month follow-up (i.e. at nine months). CONCLUSION: Our findings suggest an inclusion effect. Although the intervention in this pilot RCT appeared to add further benefit in medication compliance, a lack of statistical power prevented us from making a strong statistical statement.

Adolescent↗

Use of pharmacy claims databases to determine rates of medication adherence.

Failure to adhere to pharmaceutical therapy leads to poor clinical outcomes and substantially increased healthcare costs. Pharmacy claims databases contain all the information required to determine adherence to therapy for populations and individual patients, but extraction and analysis of these data are difficult and time-consuming. The Standardized Therapy Adherence Research Tool (START) converts pharmacy claims databases into a standardized format to rapidly obtain comprehensive adherence information that can be used to design interventions aimed at improving adherence rates.

Databases, Factual↗

Issues in medication adherence assessment in clinical trials of the National Heart, Lung, and Blood Institute.

The mission of the National Heart, Lung, and Blood Institute is to sponsor research in the prevention, diagnosis, and treatment of heart, lung, and blood diseases. As a part of its activities toward this end, the Institute plans and conducts clinical trials that test the safety and efficacy of a broad range of preventive and treatment regimens. Many of these trials involve thousands of patients and require the cooperation of many research clinics under a common protocol, often for many years. An essential component in these efforts is a standardized methodology to allow accurate tracking of adherence patterns so that problem adherence situations can be identified and rectified. This article reviews the methods that have been used to assess adherence patterns in selected clinical trials supported by the NHLBI. The most frequently used methods have been pill count and direct measurement of the drug, its metabolites, or physiological effects in some bodily fluid. Supplementary information is frequently obtained by self-report. Experience with markers has been very limited and no systematic data are available. The Aspirin Myocardial Infarction Study is used as a case study to illustrate specific strengths and weaknesses of three types of adherence assessment methods, namely, assay of salicylates in the urine, platelet aggregation, and pill count. Generalizations to other clinical trials are discussed. Based on experience to date with traditional methods of compliance assessment, several conclusions are drawn. Combinations of measures, in general, provide the most useful profiles of adherence patterns in clinical trials.(ABSTRACT TRUNCATED AT 250 WORDS)

Aspirin↗