Study protocol: The Adherence and Intensification of Medications (AIM) study - a cluster randomized controlled effectiveness study

Abstract Background Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. Methods In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. Discussion Integration of the three intervention elements - proactive identification, adherence counseling and medication intensification - is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. Trial Registration The ClinicalTrials.gov registration number is NCT00495794.http://deepblue.lib.umich.edu/bitstream/2027.42/78258/1/1745-6215-11-95.xmlhttp://deepblue.lib.umich.edu/bitstream/2027.42/78258/2/1745-6215-11-95.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/78258/3/1745-6215-11-95-S1.DOCPeer Reviewe

Improving Heart Failure Self-Management Support by Actively Engaging Out-of-Home Caregivers: Results of a Feasibility Study

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/72336/1/j.1751-7133.2008.07474.x.pd

Personalized behavior change program for glaucoma patients with poor adherence: a pilot interventional cohort study with a pre-post design

Abstract Background About half of people with glaucoma do not adhere to their recommended medications. Interventions for other chronic conditions have successfully utilized reminder systems and motivational interviewing (MI)-based counseling. This study was designed to pilot a personalized intervention that leverages these strategies to assess their impact on medication adherence in glaucoma patients. Methods Glaucoma patients taking ≥ 1 medication will be pre-screened by telephone survey for adherence to their medication(s). Those who self-report poor adherence will be enrolled in a 3-month monitoring period to measure medication adherence using electronic medication monitors. Participants who are non-adherent (take </=80% of their medication doses) over the 3-month run in phase will be eligible for the study. We plan to enroll 57 participants who are non-adherent to their medications. Participants’ adherence will then be continuously measured with electronic medication monitors, by self-report, and via pharmacy refill data over 2 years, during which two successively more resource-intensive components of an intervention aimed to improve medication adherence will be administered. The first component is a 3-month period of reminders (audio and/or visual) and text message or automated phone call if a dose of medication is not taken within a pre-specified time frame. The second component is a 6-month MI-based counseling program with a trained glaucoma counselor. This component uses the eyeGuide, a computer-based personalized behavior change program that enables para-professional staff to provide personalized education and counseling for glaucoma. The primary outcome is change in medication adherence. The secondary outcomes include changes in clinical outcomes (intraocular pressure, IOP, and IOP fluctuation) and psychosocial mediators of adherence (e.g., competence, energy for change and satisfaction). Participants will undergo semi-structured interviews at 12 months to give feedback about the counseling program in order to improve it. Discussion This pilot study will provide insight into ways to deliver more personalized health care to non-adherent glaucoma patients in order to better support them in managing their chronic disease. Trial registration Retrospectively registered with ClinicalTrials.gov ( NCT03159247 ).https://deepblue.lib.umich.edu/bitstream/2027.42/145182/1/40814_2018_Article_320.pd

A pilot study of a Community Health Agent-led type 2 diabetes self-management program using Motivational Interviewing-based approaches in a public primary care center in São Paulo, Brazil

Abstract Background Rates of noncommunicable diseases (NCDs) such as type 2 diabetes are escalating in low and middle-income countries such as Brazil. Scalable primary care-based interventions are needed to improve self-management and clinical outcomes of adults with diabetes. This pilot study examines the feasibility, acceptability, and outcomes of training community health agents (CHAs) in Motivational Interviewing (MI)-based counseling for patients with poorly controlled diabetes in a primary care center in São Paulo, Brazil. Methods Nineteen salaried CHAs participated in 32 h of training in MI and behavioral action planning. With support from booster training sessions, they used these skills in their regular monthly home visits over a 6 month period with 57 diabetes patients with baseline HbA1cs > 7.0%. The primary outcome was patients’ reports of the quality of diabetes care as measured by the Portuguese version of the Patient Assessment of Chronic Illness Care (PACIC) scale. Secondary outcomes included changes in patients’ reported diabetes self-management behaviors and in A1c, blood pressure, cholesterol and triglycerides. We also examined CHAs’ fidelity to and experiences with the intervention. Results Patients reported improvements over the 6 month period in quality of diabetes care received (PACIC score improved 33 (+/−19) to 68 (+/−21) (p < .001)). They reported increases in physical activity (p = .001), consumption of fruits and vegetables (p < .001) and medication adherence (p = .002), but no decreases in consumption of high-fat foods (p = .402) or sweets (p = .436). Participants had mean 6-month A1c levels 0.34% points lower than at baseline (p = .08) and improved mean LDL (−16.1 mg/dL, p = .005) and triglyceride levels (−38.725 mg/dL, p = .002). Of the 16 CHAs observed in fidelity assessments, 13 were categorized as medium- or high-performing on MI skills, while 3 were low-performing. CHAs expressed enthusiasm about learning new skills, and many described a shift from advice-giving to encouraging patients to define their own goals. Conclusion In resource-scarce settings, it is essential to fully utilize existing primary care resources to stem the epidemic of diabetes and other NCDs. Our pilot results support the potential of training CHAs to incorporate effective diabetes self-management support into their routine patient encounters. Trial registration NCT02994095 12/14/2016 Registered retrospectively.http://deepblue.lib.umich.edu/bitstream/2027.42/135718/1/12913_2016_Article_1968.pd

No One Could Say: Accessing Emergency Obstetrics Information as a Prospective Prenatal Patient in Post-Roe Oklahoma

This report by the Center for Reproductive Rights, Physicians for Human Rights, and Oklahoma Call for Reproductive Justice raises concerns about pregnant patients' ability to access life-saving obstetric care in states where abortion is banned

Factors Influencing Cost-Related Nonadherence to Medication in Older Adults: A Conceptually Based Approach

Although multiple noncost factors likely influence a patient's propensity to forego treatment in the face of cost pressures, little is known about how patients' sociodemographic characteristics, physical and behavioral health comorbidities, and prescription regimens influence cost-related nonadherence (CRN) to medications. We sought to determine both financial and nonfinancial factors associated with CRN in a nationally representative sample of older adults.We used a conceptual model developed by Piette and colleagues that describes financial and nonfinancial factors that could increase someone's risk of CRN, including income, comorbidities, and medication regimen complexity. We used data from the 2004 wave of the Health and Retirement Study and the 2005 HRS Prescription Drug Study to examine the influence of factors within each of these domains on measures of CRN (including not filling, stopping, or skipping doses) in a nationally representative sample of Americans age 65+ in 2005.Of the 3071 respondents who met study criteria, 20% reported some form of CRN in 2005. As in prior studies, indicators of financial stress such as higher out-of-pocket payments for medications and lower net worth were significantly associated with CRN in multivariable analyses. Controlling for these economic pressures, relatively younger respondents (ages 65–74) and depressive symptoms were consistent independent risk factors for CRN.Noncost factors influenced patients' propensity to forego treatment even in the context of cost concerns. Future research encompassing clinician and health system factors should identify additional determinants of CRN beyond patients' cost pressures.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/78680/1/j.1524-4733.2009.00679.x.pd

The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial

Abstract Background Diabetes shared medical appointments (SMAs) and reciprocal peer support programs have been found in efficacy trials to help adults with diabetes improve their self-management and achieve short-term gains in clinical and patient-centered outcomes. In order to translate this evidence to system-level interventions, there is a need for large-scale, pragmatic trials that examine the effectiveness, implementation, and costs of SMAs and reciprocal peer support across diverse settings. Methods The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study is a multisite, cluster randomized trial that is evaluating the effectiveness and implementation of SMAs with and without an additional reciprocal Peer-to-Peer (P2P) support program, when compared to usual care. The P2P program comprises periodic peer support group sessions and telephone contact between SMA participant pairs to promote more effective diabetes self-management. We will examine outcomes across three different treatment groups: (1) SMAs, (2) SMAs plus P2P, and (3) usual care. We will collect and analyze data over a 2.5-year implementation period at five geographically diverse Veterans Affairs (VA) health systems. The primary outcome is the relative change in hemoglobin A1c over time. Secondary outcomes are changes in systolic blood pressure, antihypertensive medication use, statin use, and insulin initiation over the study period. The unit of analysis is the individual, adjusted by the individual’s SMA group (the cluster). We will use mixed methods to rigorously evaluate processes and costs of implementing these programs in each of the clinic settings. Discussion We hypothesize that patients will experience improved outcomes immediately following participation in SMAs and that augmenting SMAs with reciprocal peer support will help to maintain these gains over time. The results of this study will be among the first to examine the effects of diabetes SMAs alone and in conjunction with P2P in a range of real-life clinical settings. In addition, the study will provide important information on contextual factors associated with successful program implementation. Trial registration ClinicalTrials.gov, ID: NCT02132676 . Registered on 21 August 2013.https://deepblue.lib.umich.edu/bitstream/2027.42/136794/1/13063_2017_Article_1959.pd

Hospitalizations and Deaths Among Adults With Cardiovascular Disease Who Underuse Medications Because of Cost A Longitudinal Analysis

Context: It is well-documented that the financial burden of out-ofpocket expenditures for prescription drugs often leads people with medication-sensitive chronic illnesses to restrict their use of these medications. Less is known about the extent to which such costrelated medication underuse is associated with increases in subsequent hospitalizations and deaths. Objective: We compared the risk of hospitalizations among 5401 and of death among 6135 middle-aged and elderly adults with one or more cardiovascular diseases (diabetes, coronary artery disease, heart failure, and history of stroke) according to whether participants did or did not report restricting prescription medications because of cost. Design and Setting: A retrospective biannual cohort study across 4 cross-sectional waves of the Health and Retirement Study, a nationally representative survey of adults older than age 50. Using multivariate logistic regression to adjust for baseline differences in sociodemographic and health characteristics, we assessed subsequent hospitalizations and deaths between 1998 and 2006 for respondents who reported that they had or had not taken less medicine than prescribed because of cost. Results: Respondents with cardiovascular disease who reported underusing medications due to cost were significantly more likely to be hospitalized in the next 2 years, even after adjusting for other patient characteristics (adjusted predicted probability of 47% compared with 38%, P Ͻ 0.001). The more survey waves respondents reported cost-related medication underuse during 1998 to 2004, the higher the probability of being hospitalized in 2006 (adjusted predicted probability of 54% among respondents reporting cost-related medication underuse in all 4 survey waves compared with 42% among respondents reporting no underuse, P Ͻ 0.001). There was no independent association of cost-related medication underuse with death. Conclusions: In this nationally representative cohort, middle-aged and elderly adults with cardiovascular disease who reported cutting back on medication use because of cost were more likely to report being hospitalized over a subsequent 2-year period after they had reported medication underuse. The more extensively respondents reported cost-related underuse over time, the higher their adjusted predicted probability of subsequent hospitalization

New research directions on disparities in obesity and type 2 diabetes

Obesity and type 2 diabetes disproportionately impact U.S. racial and ethnic minority communities and lowâ income populations. Improvements in implementing efficacious interventions to reduce the incidence of type 2 diabetes are underway (i.e., the National Diabetes Prevention Program), but challenges in effectively scalingâ up successful interventions and reaching atâ risk populations remain. In October 2017, the National Institutes of Health convened a workshop to understand how to (1) address socioeconomic and other environmental conditions that perpetuate disparities in the burden of obesity and type 2 diabetes; (2) design effective prevention and treatment strategies that are accessible, feasible, culturally relevant, and acceptable to diverse population groups; and (3) achieve sustainable health improvement approaches in communities with the greatest burden of these diseases. Common features of guiding frameworks to understand and address disparities and promote health equity were described. Promising research directions were identified in numerous areas, including study design, methodology, and core metrics; program implementation and scalability; the integration of medical care and social services; strategies to enhance patient empowerment; and understanding and addressing the impact of psychosocial stress on disease onset and progression in addition to factors that support resiliency and health.This report discusses a workshop convened by the National Institutes of Health to understand how to (1) address socioeconomic and other environmental conditions that perpetuate disparities in the burden of obesity and type 2 diabetes; (2) design effective prevention and treatment strategies that are accessible, feasible, culturally relevant, and acceptable to diverse population groups; and (3) achieve sustainable health improvement approaches in communities with the greatest burden of these diseases.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/154507/1/nyas14270_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/154507/2/nyas14270.pd