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Characteristics associated with suboptimal viral suppression at delivery in human immunodeficiency virus-1-infected pregnant women.

OBJECTIVE: This study was undertaken to determine clinical characteristics and factors associated with suboptimal viral suppression at delivery in human immunodeficiency virus (HIV)-infected women. STUDY DESIGN: All HIV-infected women who delivered at a single urban tertiary care center from January 1999 to June 2004 were studied. Women were divided into 2 groups based on HIV viral load (VL) proximate to delivery: VL < 1000 copies per milliliter and VL > or = 1000 copies per milliliter. Demographic and clinical factors were analyzed and compared between the 2 groups. RESULTS: A total of 146 women had adequate data available for analysis: 102 (69.9%) had VL < 1000 copies per milliliter and 44 (30.1%) had VL > or = 1000 copies per milliliter at delivery. Women with a viral load > or = 1000 copies per milliliter at delivery were more likely to have a baseline viral load VL > or = 10,000 copies per milliliter (66.7% vs 32%, P < .001) and less likely to report medication adherence, (50% vs 87.8%, P < .001). CONCLUSION: Our findings support the concept that in addition to antiviral medical therapy, intervention to improve adherence and maintaining a low baseline VL are key components to VL suppression in pregnancy.

Adult↗

Pediatric appointment keeping: improving adherence in a primary care allergy clinic.

We evaluated the effects of introducing and discontinuing an intervention designed to improve adherence with scheduled appointments in a pediatric allergy clinic. Five nonadherent and three adherent patients received reminders and incentives for keeping their scheduled appointments. Adherence with appointments increased for three of the five nonadherent children, who had an average increase of 13%, and adherent patients continued to keep appointments during the intervention condition. After 10 scheduled allergy clinic appointments had been kept, incentives were discontinued while reminders continued. Improvements in adherence were not maintained after incentives were discontinued and two children showed reductions in adherence to below-baseline levels. Incentive programs increase appointment keeping, but discontinuing incentives abruptly may result in the return of nonadherence, even when reminders are provided as a maintenance strategy. Future pediatric psychology research and practice should investigate both the benefits and limitations of strategies designed to improve adherence.

Adolescent↗

Can practice guidelines be transported effectively to different settings? Results from a multicenter interventional study.

RATIONALE: Although clinical guidelines have become increasingly popular as a means to reduce variation in care, increase efficiency, and improve patient outcomes, little is known about their effectiveness when they are transported outside their original setting, or about the factors that influence their successful translation into clinical practice. This study assessed whether a clinical guideline for low-risk chest pain patients, implemented with a standardized protocol, could be effectively transported to five hospital settings. METHODS: In a prospective, interventional trial, a standardized protocol for low-risk chest pain was implemented at each site. A total of 553 consecutively hospitalized low-risk patients with chest pain were enrolled during a 3-month baseline period followed by a standardized 6-month intervention period. During the intervention period, each patient's physician was contacted about eligibility for discharge within the specified 2-day guideline period. Guideline adherence (discharged within 48 hours) and postdischarge patient outcomes were measured. Local guideline champions were interviewed about their implementation experience. RESULTS: Guideline adherence during the intervention period ranged from 61% to 100%, with only two sites achieving significant increases of > or = 10% from the baseline values. Guideline implementation did not affect clinical outcomes or patient satisfaction. Implementation factors such as preexisting hospital environment, implementation team staffing, and the rapid identification and resolution of barriers may influence the successful translation of guidelines into practice. CONCLUSIONS: Even with a standardized implementation protocol, consistent results across institutions were not obtained when a clinical guideline for chest pain was implemented beyond its original setting. These findings demonstrate the importance of understanding the local factors that influence guideline implementation.

Aged↗

Measuring adherence to antiretroviral medications in clinical trials.

Antiretroviral medications have the potential to transform HIV infection from a fatal to a chronic disease. One of the significant barriers to clinical success is medication nonadherence. Measuring adherence in clinical trials is increasingly important because inadequate adherence may explain some of the variation in clinical response in antiretroviral clinical trials. Additionally, to quantitate the success of interventions that improve adherence, accurate measures need to be utilized. This article summarizes commonly used adherence measures in HIV clinical trials and observational studies such as patient self-report, pill counts, plasma levels, and electronic monitoring. The merits and shortcomings of each measure are discussed.

Antiretroviral Therapy, Highly Active↗

Medication packaging: simple solutions to nonadherence problems?

Medication nonadherence represents a well-documented, highly prevalent obstacle to successful long-term management of chronic illnesses. Recent research has focused on predictors of nonadherence, interventions for improving adherence, and measurement of medication adherence. Better medication packaging has received little attention as a partial solution to nonadherence complexities. Packaging has the obvious advantages of being continuous, inexpensive, and patient-oriented, while demanding little physician extra involvement. The ideal packaging solution should include six component functions: storage, education, cueing, monitoring, dispensing, and reinforcement. Practically, all six functions are highly interrelated necessitating tradeoffs. Combining several functions usually results in increased cost and decreased portability. A number of proposed devices for specific adherence-improving function are described, ranging from complex to simple. The need for more and better research to define and validate interventions is more critical, now that we recognize the consequences of nonadherence.

Cues↗

Facilitating adherence to the tobacco use treatment guideline with computer-mediated decision support systems: physician and clinic office manager perspectives.

BACKGROUND: A majority of physicians do not adhere to all the elements of the evidence-based USPHS guideline on tobacco use and dependence treatment. Among physicians and clinic office managers in Vermont we assessed perceived barriers to guideline adherence. We then assessed attitudes towards a computer-mediated clinical decision support system (CDSS) to gauge whether this type of intervention could support performance of the guideline. METHODS: A random sample of 600 Vermont primary care and subspecialty physicians were surveyed with a mailed survey instrument. A separate survey instrument was mailed to the census of 93 clinic office managers. RESULTS: The response rates of physicians and clinic office managers were 67% and 76%, respectively. Though most physicians were aware of the guideline and had positive attitudes towards it, there was a lack of familiarity with Vermont's smoking cessation resources as 35% would refer smokers to non-existent counseling resources and only 48% would refer patients to a toll-free quit line. Time constraints and the perception that smokers are unreceptive to counseling were the two most common barriers cited by both physicians and office managers. The vast majority of physicians (92%) have access to a computer in their outpatient clinics, and 68% have used computers during the course of a patient's visit. Four of the eight information management services that a CDSS could provide were highly valued by both physicians and clinic office managers. CONCLUSIONS: Interventions to improve adherence to the guideline should address the inaccurate perception that smokers are unreceptive to counseling, and physicians' lack of familiarity with resources. A CDSS may improve knowledge of these resources if the design addresses cost, space, and time limitations.

Adult↗

Physicians' knowledge and attitudes about coronary heart disease prevention guidelines and technology assisted interventions.

BJC Healthcare is conducting a randomized controlled study to evaluate the impact of a technology-assisted pharmacist intervention on physicians' adherence to national coronary heart disease (CHD) prevention guidelines. We surveyed physicians to assess their knowledge of the guidelines and attitudes toward pharmacist-mediated interventions.

Attitude of Health Personnel↗

Effect of intervention through a pharmaceutical care program on patient adherence with prescribed once-daily atorvastatin.

AIMS: Correct execution of prescribed dosing regimen(s) is essential for patients to benefit from lipid lowering treatments. The objective of this study was to estimate the effect of a pharmaceutical care program on the adherence of once-daily atorvastatin treatment in patients with elevated cholesterol levels. METHODS: In both linguistic regions of Belgium, two districts were randomized between usual care and a supportive intervention program. Eligible patients included hyperlipemic subjects taking atorvastatin for at least 3 months. 'Adherence' was defined as the proportion of days during which the electronic device record showed that the patient had taken the daily dose. 'Persistence' quantifies how long the treatment is executed. RESULTS: A total of 392 patients from 35 pharmacies were included in the intent-to-treat (ITT) analysis of the data (194 patients received intervention and 198 in the control group). The intervention resulted in a 6.5% increase in post-baseline adherence (p < 0.001) mainly driven by a 13% increase in persistence at 1 year (p = 0.002). CONCLUSION: A supportive pharmaceutical care program consisting of review by patient and pharmacist of each patient's electronically compiled dosing history, plus educational reminders, improves patient adherence to the once-daily atorvastatin dosing regimen, mainly by extending persistence.

Atorvastatin↗

Association between adherence to diuretic therapy and health care utilization in patients with heart failure.

STUDY OBJECTIVE: To determine the relationship between adherence to diuretic therapy and health care utilization. DESIGN: Prospective, observational study. SETTING: University-affiliated medical center. PATIENTS: Forty-two patients with heart failure. INTERVENTION: Electronic monitoring of adherence to diuretic therapy (percentage of diuretic prescription container openings) and to scheduling (percentage of container openings within a specific time). MEASUREMENTS AND MAIN RESULTS: All patients were prescribed a diuretic, most commonly furosemide (88%). Patients varied widely in adherence to therapy (mu = 72% +/- 30%) and to scheduling (mu = 43% +/- 30%). Education was a predictor of drug-taking adherence (p=0.0062) but not of scheduling adherence. Log-linear models revealed that poor scheduling adherence was associated with increased cardiovascular-related hospitalizations (chi2 11.63, p=0.0006) and predicted more heart failure-related hospitalizations (chi2 4.04, p=0.0444). In contrast, neither measure was significantly associated with cardiovascular- or heart failure-related emergency department visits. We found a moderate correlation between scheduling adherence and taking adherence (r = 0.6513). CONCLUSION: Patients taking a greater proportion of diuretic agents on schedule may decrease the risk of cardiovascular- and heart failure-related hospitalizations. If these findings are confirmed by a larger study, interventions to improve adherence and patient health outcomes should consider the timing of doses as well as the number of daily doses of a diuretic.

Diuretics↗

Couple-focused support to improve HIV medication adherence: a randomized controlled trial.

OBJECTIVE: To assess the efficacy of a couple-based intervention to improve medication-taking behavior in a clinic population with demonstrated adherence problems. DESIGN: A randomized controlled trial (SMART Couples Study) conducted between August 2000 and January 2004. SETTING: Two HIV/AIDS outpatient clinics in New York City. PARTICIPANTS: Heterosexual and homosexual HIV-serodiscordant couples (n = 215) in which the HIV-seropositive partner had < 80% adherence at baseline. The sample was predominantly lower-income racial/ethnic minorities. INTERVENTION: Participants were randomly assigned to a four-session couple-focused adherence intervention or usual care. The intervention consisted of education about treatment and adherence, identifying adherence barriers, developing communication and problem-solving strategies, optimizing partner support, and building confidence for optimal adherence. OUTCOME MEASURES: Medication adherence at week 8 (2 weeks after the intervention) compared with baseline, assessed with a Medication Event Monitoring System cap. RESULTS: Intervention participants showed higher mean medication adherence at post-intervention when compared with controls whether adherence was defined as proportion of prescribed doses taken (76% versus 60%) or doses taken within specified time parameters (58% versus 35%). Also, participants in the intervention arm were significantly more likely to achieve high levels of adherence (> 80%, > 90%, or > 95%) when compared with controls. However, in most cases, effects diminished with time, as seen at follow-up at 3 and 6 months. CONCLUSION: The SMART Couples program significantly improved medication adherence over usual care, although the level of improved adherence, for many participants, was still suboptimal and the effect was attenuated over time.

Adult↗

Adherence to medication regimens among children with human immunodeficiency virus infection.

BACKGROUND: Rigorous adherence to antiretroviral medication regimens is necessary to achieve and maintain undetectable viral levels. This study describes adherence in a population of children with HIV infection. METHODS: Caregivers of HIV-infected children were interviewed about their experiences with administration of medications for treatment of HIV, opinions regarding medication-related issues and the potential usefulness of interventions to improve adherence. RESULTS: In the 90 caregiver interviews completed, 78% of the children were taking 3 or more medications, 17% missed a dose in the previous 24 h and 43% missed at least 1 dose in the previous week. Children whose caregivers reported no missed doses in the previous week (adherent) were more likely to have an HIV viral load <400 copies/ml (50% vs. 24%, P = 0.04). Nonadherent caregivers (who reported 1 or more missed doses in the previous week) were more likely than adherent caregivers to agree with a statement that full adherence is impossible (44% vs. 12%, P = 0.001) and express the need for more help with medication administration (26% vs. 6%, P = 0.02). They were less likely to have informed the school or day-care site about the child's HIV infection (42% vs. 67%, P = 0.05) and more concerned about the child's teachers and friends finding out (54% vs. 31%, P = 0.05). Of 10 potential interventions 6 were rated by a majority of respondents as "very helpful": better tasting medications (81%); longer dosing intervals (72%); medications that did not require refrigeration (63%); access to 24-h telephone advice (62%); a follow-up call from a health care provider (57%); and a pill organizer (56%). CONCLUSIONS: Caregivers' perceptions that adherence is too difficult or concerns about loss of privacy may affect their ability to adhere to complicated medication regimens. Caregivers felt that the most helpful interventions would be modifications to improve the convenience and palatability of medications and increased access to medical advice.

Adolescent↗

Physician alerts to increase antidepressant adherence: fax or fiction?

BACKGROUND: Many managed care organizations use feedback based on electronically maintained claims data to alert physicians to potential treatment problems, including patient medication nonadherence. However, the efficacy of such interventions for improving adherence among patients treated for depression is unknown. METHODS: We examined an antidepressant compliance program consisting of faxed alerts to physicians beginning May 2003 using interrupted time series analysis to evaluate its impact on rates of antidepressant adherence between May 2002 and May 2004 among members of the managed care plan of Harvard Pilgrim Health Care, which is a health plan operating in 3 states in New England, with corporate headquarters in Wellesley, Mass. The program alerted prescribing physicians to patients with gaps of more than 10 days in refilling antidepressant prescriptions during the first 180 days of treatment. Our outcome measures were rates of nonadherence among patients with refill gaps of more than 10 days ("delayed refill") and proportion of days without treatment within the first 180 days of treatment. RESULTS: A total of 13 128 patients (> or = 18 years of age) who were starting treatment with antidepressants met the study criteria. Rates of nonadherence among patients with delayed refills remained constant (P = .22) over the 2-year study period, averaging 75% (95% confidence interval, 72.7%-77.3%). Rates of antidepressant nonadherence significantly increased over time (P = .04), with an average of 40% (95% confidence interval, 38.4%-41.6%) of days without dispensed antidepressants available during treatment episodes. CONCLUSIONS: Using real-time pharmacy information to alert physicians regarding patient adherence was not successful in increasing antidepressant adherence rates among members of the managed care plan. Effectiveness of electronically triggered, patient-specific, faxed feedback should be carefully evaluated before widespread implementation, because faxes are insufficient as a stand-alone policy tool.

Adult↗

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↗

Visual-feedback therapy for antipsychotic medication adherence.

This pilot study aimed to examine the effectiveness of visual-feedback therapy for individuals with psychotic disorders. Visual-feedback therapy combines structured psychodynamic therapy and visual feedback achieved via an electronic monitoring medication cap to increase insight about medication behaviours. Thirty subjects were randomly assigned either to visual feedback or to a supportive counselling group. Medication adherence was measured by both electronic monitoring and blood plasma drug concentration levels. The results showed that, at the end of the 3-month, intervention (bimonthly sessions), adherence rates of the visual-feedback group slightly increased, but declined during the course of the study for the supportive counselling control group (P=0.026).

Adult↗

Assessing the strength and integrity of an intervention.

PURPOSE/OBJECTIVES: To evaluate the strength and integrity of a pilot behavioral intervention designed to assist mothers with breast cancer and their children. RESEARCH APPROACH: A single-group analysis of the strength and integrity characteristics of an intervention developed for a pilot research study. SETTING: Homes of study participants in an urban area. PARTICIPANTS: Seven households with a mother and father and one household with a single mother. METHODOLOGIC APPROACH: Observer-reported checklists, audiorecorded intervention session data, and structured interview data obtained from study participants. MAIN RESEARCH VARIABLES: Strength of the intervention included dimensions such as the theoretical foundation, competence of the interventionist, and specificity to the breast cancer experience in the family. Intervention integrity consisted of adherence by the interventionist and participants to the intervention plan. FINDINGS: The strength of the intervention was determined to be an asset. Careful planning had included a framework, a defined set of scripted sessions, a competent interventionist, and content specific to the breast cancer experience. In regard to integrity, the protocol content was delivered as scripted. Improvements in the dosage and purity dimensions were found to be needed. Homework assignments and in-session skill-building approaches with the mothers were refined. CONCLUSIONS: An intervention can be examined carefully for strength and integrity with established criteria to determine improvements needed. INTERPRETATION: A clinical research protocol can be improved through an assessment of an intervention's strength and integrity.

Adolescent↗

A pilot study of health beliefs and attitudes concerning measures of antiretroviral adherence among prisoners receiving directly observed antiretroviral therapy.

High level adherence to antiretroviral therapy (ART) is required to achieve and maintain suppression of HIV replication. Although directly observed therapy (DOT) has been suggested as an intervention to improve adherence, there is a paucity of data describing the attitudes and beliefs regarding DOT for ART among HIV-infected individuals. This study was designed to evaluate the acceptability and psychometric properties of a survey instrument for use in assessing barriers and facilitators of adherence to ART DOT in prison. From July 1, 1999 to April 1, 2000, we piloted an interviewer-administered questionnaire to assess health beliefs and attitudes regarding HIV treatment among 65 HIV-infected prison inmates receiving one or more of their antiretrovirals via directly observed therapy (DOT). The first 24 participants were administered the questionnaire to determine the feasibility of surveying prisoners in a correctional setting. There were no adherence data collected on these participants. The remaining 41 participants had their adherence measured in addition to receiving the questionnaire. Thirty-one were included in the final analysis because 10 did not complete the study. Multiple antiretroviral adherence measures (electronic device medication monitoring [eDEM] caps, medication administration records [MARs], and pill counts) were assessed among a subset of the participants (n = 31) and correlated to the instrument response items. The median internal consistency reliability coefficient for the multi-item scales was 0.79. The strongest correlation between inmates' beliefs and their adherence was between "positive beliefs about protease inhibitors" and the MAR adherence measure (r = 0.72; p < 0.001). This study provides preliminary support for the psychometric properties of the survey in this correctional setting.

Anti-Retroviral Agents↗

Health Literacy and Capecitabine Adherence in a Remote Monitoring Pilot Trial for Breast Cancer: Post Hoc Exploratory Analysis.

BACKGROUND: Oral anticancer therapy enables convenient, home-based cancer care but can introduce adherence challenges, particularly with complex dosing schedules. Capecitabine is commonly used in breast cancer, often as adjuvant therapy or in advanced disease, and typically requires twice-daily dosing on cyclical schedules, increasing the risk of missed or incorrect doses. Low health literacy may exacerbate these difficulties, and emerging remote monitoring tools may help close this gap. OBJECTIVE: In this post hoc exploratory analysis, we evaluated whether health literacy (1) was associated with capecitabine adherence and (2) modified a remote monitoring intervention's effectiveness. METHODS: We conducted post hoc analyses of a 2-arm pilot trial that randomized women with breast cancer treated with capecitabine to enhanced usual care (EUC) or remote patient monitoring (RPM). Adherence was captured with a smart pill bottle, Nomi by SMRxT, that recorded dose timing and quantity. Participants in the RPM group received messages for missed or incorrect doses and weekly symptom assessments. Incorrect or missed doses and severe symptoms triggered alerts to the oncologist. Health literacy was assessed at enrollment. To evaluate moderation, we used linear regression with an interaction term (health literacy &#xd7; intervention arm) predicting adherence (proportion of days). Marginal effects quantified differences in adherence by study arm and health literacy. RESULTS: Among 28 participants (EUC, n=15 and RPM, n=13), 9 (32.1%) had lower health literacy, 16 (57.1%) identified as Black, 10 (35.7%) identified as White, and 15 (53.6%) had income below 200% of the federal poverty level. In the regression model, the health literacy &#xd7; randomized group interaction did not reach statistical significance (-16.3 percentage points, 95% CI -35.5 to 2.9; P=.09). Predicted adherence among lower health literacy participants was 87.5% in the RPM group and 65.5% in the EUC group (difference: +22.1 percentage points, 95% CI 6.2-37.9; P=.008). Among participants with higher health literacy, adherence was 89.9% in the RPM group and 84.1% in the EUC group (difference: +5.7 percentage points, 95% CI -5.2 to 16.7; P=.29). Within the EUC group, predicted adherence was 18.6 percentage points lower among those with lower versus higher health literacy (95% CI -32.4 to -4.9; P=.01); within the RPM group, this difference was 2.3 percentage points lower among those with lower versus higher health literacy (95% CI -15.8 to 11.1; P=.73). CONCLUSIONS: In this post hoc exploratory analysis, the estimated difference in capecitabine adherence between the RPM and EUC groups was larger among participants with lower health literacy. Although the formal interaction test was not statistically significant, the magnitude and direction of the observed difference support further investigation of RPM as a potential approach to improve adherence among patients facing health literacy-related adherence barriers. Larger, prospectively powered studies are needed to confirm these findings and evaluate downstream clinical outcomes.

Humans↗

Adherence to antipsychotic and nonpsychiatric medications in middle-aged and older patients with psychotic disorders.

OBJECTIVE: The prevalence and consequences of nonadherence to antipsychotic medications in schizophrenia and related psychotic disorders have been well described; however, little is known about adherence to medications for nonpsychiatric conditions in patients with psychotic disorders. We wished to determine medication adherence in nondemented middle-aged and older Veterans Affairs outpatients with schizophrenia or other psychotic disorders who had been prescribed oral medications for hypertension, hyperlipidemia, or diabetes. METHODS: Medication adherence was assessed by review of medication fill records for 76 patients aged 40 years and older who had been prescribed an oral antipsychotic in addition to an oral agent for hypertension (N = 60), hyperlipidemia (N = 28), or diabetes (N = 24). Up to 12 months of therapy was reviewed, and a compliant fill rate (the number of adherent fills in proportion to the total number of prescription fills) and cumulative mean gap ratio (the number of days when medication was unavailable in relation to the total number of days) were calculated for each medication. RESULTS: The 12-month mean compliant fill rates for antipsychotics, antihypertensives, antihyperlipidemics, and antidiabetics ranged from 52% to 64%. Nonpsychiatric medication adherence rates were similar in patients on typical vs. atypical antipsychotics and did not correlate significantly with antipsychotic adherence rates. CONCLUSIONS: Nonadherence rates were found to be equally problematic for both antipsychotic and nonpsychiatric medications in middle-aged and older patients with psychotic disorders. Interventions to improve adherence to both antipsychotic and nonpsychiatric medications are needed.

Adult↗