Association between medication regimen complexity and glycemic control among patients with type 2 diabetes.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) and comorbid conditions require patients to take complex medication regimens. Greater regimen complexity has been associated with poorer T2DM management; however, the relationship between overall regimen complexity and glycemic control is unclear. OBJECTIVES: Our objectives were: (1) to examine associations between regimen complexity (with the Medication Regimen Complexity Index [MRCI]) and glycemic control (A1C), and (2) to compare overall MRCI with other measures of regimen complexity (overall and diabetes-specific medication count) and diabetes-specific MRCI. METHODS: This was a secondary data analysis of cross-sectional data from a parent trial. Participants were patients with T2DM taking at least 3 chronic medications followed in safety net clinics in the Chicago area. The MRCI measures complexity based on dosing frequency, route of administration, and special instructions for prescribed medications. MRCI scores were created for overall regimens and diabetes-specific medications. Sociodemographics and outpatient visit utilization were included in models as covariates. Linear regression was used to examine the associations between variables of interest and hemoglobin A1C. RESULTS: Participants (N = 432) had a mean age of 56.9 years, most were female (66.0%), and Hispanic or Latino (73.3%). Regimen complexity was high based on overall medications (mean = 6.6 medications, SD: 3.09) and MRCI (mean = 21.4, SD: 11.3). Higher diabetes-specific MRCI was associated with higher A1C in bivariate and multivariable models. In multivariable models, overall MRCI greater than 14, fewer outpatient health care visits, male gender, and absence of health insurance were independently associated with higher A1C. The variance in A1C explained by MRCI was higher compared to medication count for overall and diabetes-specific regimen complexity. CONCLUSIONS: More complex regimens are associated with worse A1C and measuring complexity with MRCI may have advantages. Deprescribing, increasing insurance coverage, and promoting engagement in health care may improve A1C among underserved populations with complex regimens.

Knowledge and Behaviors of Adults with Underlying Health Conditions During the Onset of the COVID-19 U.S. Outbreak: The Chicago COVID-19 Comorbidities Survey.

Accurate understanding of COVID-19 safety recommendations early in the outbreak was complicated by inconsistencies in public health and media messages. We sought to characterize high-risk adults' knowledge of COVID-19 symptoms, prevention strategies, and prevention behaviors. We used data from the Chicago COVID-19 Comorbidities (C3) survey collected between March 13 thru March 20, 2020. A total of 673 predominately older adults with ≥ 1 chronic condition completed the telephone interview. Knowledge was assessed by asking participants to name three symptoms of COVID-19 and three actions to prevent infection. Participants were then asked if and how they had changed plans due to coronavirus. Most participants could identify three symptoms (71.0%) and three preventive actions (69.2%). Commonly reported symptoms included: fever (78.5%), cough (70.6%), and shortness of breath (45.2%); preventive actions included: washing hands (86.5%) and social distancing (86.2%). More than a third of participants reported social distancing themselves (38.3%), and 28.8% reported obtaining prescription medication to prepare for the outbreak. In multivariable analyses, no participant characteristics were associated with COVID-19 knowledge. Women were more likely than men, and Black adults were less likely than White adults to report practicing social distancing. Individuals with low health literacy were less likely to report obtaining medication supplies. In conclusion, though most higher-risk individuals were aware of social distancing as a prevention strategy early in the outbreak, less than half reported enacting it, and racial disparities were apparent. Consistent messaging and the provision of tangible resources may improve future adherence to safety recommendations.

Implementation fidelity of patient-centered prescription label to promote opioid safe use.

PURPOSE: Patient-centered labels may improve safe medication use, but implementation challenges limit use. We assessed implementation of a patient-centered "PRN" (as needed) label entitled "Take-Wait-Stop" (TWS) with three deconstructed steps replacing traditional wording. METHODS: As part of a larger investigation, patients received TWS prescriptions (eg, Take: 1 pill if you have pain; Wait: at least 4 h before taking again; Stop: do not take more than 6 pills in 24 h). Prescriptions labels recorded at follow-up were classified into three categories: (1) one-step wording (Take 1 pill every 4 h [without daily limits]), (2) two-step wording (Take 1 pill every 4 h; do not exceed 6 pills/day), and (3) three-step wording. There were three subtypes of three-step wording: (3a) three-step, not TWS (three deconstructed steps, not necessarily TWS wording), (3b) TWS format, employing three steps with leading verbs, but "with additions or replacements" (eg, replaced "do not take" with "do not exceed"), and (3c) verbatim TWS. RESULTS: Two hundred eleven participants completed follow-up. Mean age was 44.3 years (SD 14.3); 44% were male. One-step bottles represented 12% (n = 25) of the sample, whereas 26% (n = 55) had two-step wording. The majority (44%, n = 93) had three-deconstructed steps, not TWS (3a); 16% (n = 34) retained TWS structure, but not verbatim (3b). Only 2% (n = 4) displayed verbatim TWS wording (3c). All category three labels (utilizing deconstructed instructions) were considered adequate implementation (62%). CONCLUSIONS: Exact intervention adherence was not achieved in the majority of cases, limiting impact. Nonetheless, community pharmacies were responsive to new instructions, but higher implementation reliability requires additional supports.

What is the quality of drug safety information for patients: An analysis of REMS educational materials.

BACKGROUND: Poor-quality patient drug information has been identified as a major cause of preventable medication errors in the United States. The US Food and Drug Administration (FDA) has the authority to require marketing authorization holders of medicinal products to implement risk evaluation and mitigation strategies (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. Aside from medication guides, no research has been conducted to assess the quality of patient-targeted REMS materials, including whether, and to what extent, patients find these materials understandable and actionable. PURPOSE: To describe the readability, understandability, and actionability of patient educational materials in currently approved REMS programs, and to highlight opportunities for improving both the quality and effectiveness of these important drug safety tools. METHODS: Seventy-seven REMS programs were identified from the FDA REMS database. We excluded medication guides (MGs) from our analysis because of the fact that there is a mandatory MG template. Based on this, we identified a total of 27 (non-MG) REMS patient materials on the FDA REMS website for analysis purposes. The materials were tested for readability using the Lexile Measure, the Gunning Fog Index, and Flesch Kincaid and then assessed using the Patient Education Materials Assessment Tool for printable materials, for understandability and actionability. RESULTS: Twenty-three of 77 (30%) REMS programs used educational materials to communicate serious risks to patients, yielding a total of 27 REMS patient materials for analysis. The median readability score for these materials was at a ninth-grade reading level or higher. While most (89%) of these patient education materials met established criteria for being understandable, less than half (49%) were deemed actionable. DISCUSSION: Currently approved REMS patient materials fell short in terms of recommended reading level, and over half did not meet recommended standards for actionability. Developers of these materials should apply plain language principles when design these materials to improve their readability and to assess both understandability and actionability in order to increase the effectiveness when distributed to patients.

Older Adult Preferences of Mobile Application Functionality Supporting Medication Self-Management.

Health systems and insurers alike are increasingly interested in leveraging mHealth (mobile health) tools to support patient health-related behaviors including medication adherence. However, these tools are not widely used by older patients. This study explores patient preferences for functionality in a smartphone application (app) that supports medication self-management among older adults with multiple chronic conditions. We conducted six discussion groups in Chicago, Miami, and Denver (N = 46). English-speaking older adults (55 and older) who owned smartphones and took five or more prescription medicines were invited to participate. Discussions covered familiarity with and use of current apps and challenges with taking multidrug regimens. Participants reviewed a range of possible mobile app functions and were asked to give feedback regarding the acceptability and desirability of each to support medication management. Very few participants (n = 3) reported current use of a mobile app for medication support, although all were receptive. Challenges to medication use were forgetfulness, fear of adverse events, and managing medication information from multiple sources. Desired features included (1) a list and consolidated schedule of medications, (2) identification and warning of unsafe medication interactions, (3) reminder alerts to take medicine, and (4) the ability record when medications were taken. Features relating to refill ordering, pharmacy information, and comparing costs for medication were not considered to be as important for an app.

Characterizing Caregiver Roles and Conflict in Health Management Support to Older People With Multiple Chronic Conditions.

Caregivers provide critical support for older adults managing multiple chronic conditions (MCCs), but few studies describe the assistance caregivers provide or identify factors influencing their provision of support. We conducted qualitative interviews with 25 caregivers to older adults with MCCs to describe caregivers' roles and identify the factors that influence caregivers' ability to carry out these roles. Transcripts were analyzed using the Framework Method. Caregivers supported the management of MCCs in several ways, including monitoring conditions, communicating with clinicians, and tracking health information. Disagreement, or conflicted relationships, between caregivers and older adults over health and behaviors influenced the provision of support, resulting in less involved and less effective caregivers. Caregivers in conflicted relationships were more challenged by resistance from older adults. Greater agreement, or collaboration, between caregivers and older adults resulted in more involved and effective caregivers. Addressing health-related conflict may enhance caregivers' capacity to support older adults with MCCs.

Managing medications among individuals with mild cognitive impairment and dementia: Patient-caregiver perspectives.

BACKGROUND: With changing cognitive abilities, individuals with mild cognitive impairment (MCI) and dementia face challenges in successfully managing multidrug regimens. We sought to understand how individuals with MCI or dementia and their family caregivers manage multidrug regimens and better understand patient-to-caregiver transitions in medication management responsibilities. METHODS: We conducted qualitative interviews among patient-caregiver dyads. Eligibility included: patients with a diagnosis of MCI, mild or moderate dementia, managing ≥3 chronic conditions, ≥5 prescription medications, who also had a family caregiver ≥18 years old. Semi-structured interview guides, informed by the Medication Self-Management model, ascertained roles and responsibilities for medication management and patient-to-caregiver transitions in medication responsibilities. RESULTS: We interviewed 32 patient-caregiver dyads. Older adults and caregivers favored older adult autonomy in medication management, and individuals with MCI and mild dementia largely managed their medications independently using multiple strategies (e.g., establishing daily routines, using pillboxes). Among individuals with moderate dementia, caregivers assumed all medication-related responsibilities except when living separately. In those scenarios, caregivers set up organizers and made reminder calls, but did not observe family members taking medications. Patient-to-caregiver transitions in medication responsibilities frequently occurred after caregivers observed older adults making errors with medications. As caregivers sought to assume greater responsibilities with family members' medicines, they faced multiple barriers. Most barriers were dyadic; they affected both the older adult and the caregiver and/or the relationship. Some barriers were specific to caregivers; these included caregivers' competing responsibilities or inaccurate perceptions of dementia, while other barriers were related to the healthcare system. CONCLUSIONS: To ease medication management transitions, balance must be sought between preservation of older adult autonomy and early family caregiver involvement. Clinicians should work to initiate conversations with family caregivers and individuals living with MCI or dementia about transitioning medication responsibilities as memory loss progresses, simplify regimens, and deprescribe, as appropriate.

Medication Dosing Schedules, Medication Knowledge, and Dosing Errors of Adults Taking Complex Drug Regimens.

This study examined how patients take complex medication regimens at home. Participants were primary care patients, 21 years or older, and prescribed three or more medications. Interviews assessed medication dosing schedules, medication knowledge, and dosing errors. Participants (N=441) were middle aged (mean 56.9); the majority were Hispanic/Latino (73.4%), had limited English proficiency (59.0%), and had limited health literacy (89.0%). One in five participants dosed medication five or more times per day, although no participants in the sample had a label instructing them to take medication more than times times daily. On average, participants correctly identified the purpose of 65% of their medications. Half of participants made one or more dosing errors. Less than high school education and a regimen size of six or more medications were independently associated with less medication knowledge, whereas language discordant label instructions were associated with dosing errors. Screening for regimen dosing complication and interventions to simplify dosing schedules are needed.

Barriers and facilitators of self-management behaviors among patients with chronic obstructive pulmonary disease and chronic comorbidities: A mixed-methods investigation.

OBJECTIVES: We investigated how individuals with chronic obstructive pulmonary disease (COPD) and multi-morbidity (MM) navigate barriers and facilitators to their health management. METHODS: We conducted a mixed-methods study using semi-structured interviews and survey assessments of adults with COPD, hypertension, and/or diabetes. We recruited 18 participants with an average age of 65, with 39% being male, 50% Black, and 22% Hispanic/Latino/a. Five investigators used an iterative, hybrid-coding process combining a priori and emergent codes to analyze transcripts and compare quantitative and qualitative data for themes. RESULTS: Participants reported a generalized approach to their health rather than managing MMs separately. Individuals with good or mixed adherence found daily routines facilitated regular medication use, while those with poor adherence experienced complex prescriptions and life stressors as barriers. Walking was viewed as beneficial but challenging due to limited mobility. Most participants viewed diet as important to their MMs, but only two reported high diet quality and many held inaccurate beliefs about healthy diet choices. DISCUSSION: Participants with MM were highly motivated to engage in self-management activities, but some individuals experienced barriers to maintaining them. Emphasizing an individualized clinical approach to assessing and solving patient barriers may improve self-management outcomes in this complex population.

Caregiver involvement in managing medications among older adults with multiple chronic conditions.

OBJECTIVE: We sought to characterize caregiver medication assistance for older adults with multiple chronic conditions. DESIGN: Semi-structured qualitative interviews. SETTING: Community and academic-affiliated primary care practices. PARTICIPANTS: A total of 25 caregivers to older adults participating in an ongoing cohort study with ≥3 chronic conditions. MEASUREMENTS: A semi-structured interview guide, informed by the Medication Self-Management model, aimed to understand health-related and medication-specific assistance caregivers provided. RESULTS: Three typologies of caregiver assistance with medications emerged: Actively Involved, Peripherally Involved, and Not Involved. A total of 10 caregivers were Actively Involved, which was defined as when the caregiver perceived a need for and offered assistance, and the patient accepted the assistance. Peripherally Involved (n = 6) was defined as when the caregiver perceived a need and offered assistance; however, the patient rejected this assistance, yet relied on the caregiver as a backup in managing his or her medications. To combat resistance from the patient, caregivers in this typology disguised assistance and deployed workaround strategies to monitor medication-taking behaviors to ensure safety. Lastly, nine caregivers were classified as Not Involved, defined as when the caregiver did not perceive a need to offer assistance with medications, and the patient managed his or her medicines independently. A strong preference toward autonomy in medication management was shared across all three typologies. CONCLUSION: These findings suggest that caregivers value independent medication management by their care recipient, up until safety is seriously questioned. Clinicians should not assume caregivers are actively and consistently involved in older adults' medication management; instead, they should initiate conversations with patients and caregivers to better understand and facilitate co-management responsibilities, especially among those whose assistance is rejected by older adults.

Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review.

INTRODUCTION: Risk minimization programs are interventions mandated by regulatory agencies to ensure that benefits of pharmaceutical products outweigh risks. Many regulatory agencies require programs be evaluated for effectiveness; however, the quality of evidence has limited the ability to definitively determine if programs improve drug safety. OBJECTIVE: The aim of this systematic review was to assess and describe the current status of reporting on the effectiveness of pharmaceutical risk management programs. METHODS: Peer-reviewed articles published between January 2012 and December 2018 were selected from three online databases (MEDLINE, PubMed, Embase). Eligible studies reported on effectiveness evaluations of mandated risk minimization measures (beyond labeling) and were written in English. Two reviewers independently examined 2744 titles of articles and 52 full articles were included. Forty-eight sources of gray literature from conference abstract presentations and publicly available regulatory documents were also included. RESULTS: Key opportunities for improvement in reporting included the provision of information regarding (1) selection, design, and testing of risk minimization measures, (2) implementation of programs, (3) process and outcome metrics, including the extent to which programs reached the intended audience, were integrated into the target healthcare settings, or were sustained over time, and (4) burden of the program on the healthcare system and implications for patient access. CONCLUSIONS: Gaps in reporting of risk minimization program evaluation studies were identified. Addressing gaps will help build the evidence base regarding risk minimization initiatives, as well as ensure that programs are maximally effective and minimally burdensome on the healthcare system, and do not unduly interfere with patient access to the medicine.

Test-retest reliability of the Newest Vital Sign health literacy instrument: In-person and remote administration.

OBJECTIVE: To determine the reliability of the Newest Vital Sign (NVS) administered via telephone by examining test-retest properties of the measure. METHODS: Data were obtained from a randomized controlled trial promoting opioid safe use. Participants were 18 or older and English-speaking. NVS assessment occurred in-person at baseline and in-person or via telephone at follow-up. Intraclass correlation coefficients (ICCs) were used to assess the test-retest reliability using raw NVS scores by mode of administration of the second NVS assessment. Kappa statistics were used to examine test-retest agreement based on categorized NVS score. Internal consistency was measured with Cronbach's alpha. RESULTS: Data from 216 patients (70 completing follow-up in-person and 146 via telephone) were included. Reliability was high (ICCs: in-person = 0.81, phone = 0.70). Agreement was lower for three category NVS score (Kappas: in-person = 0.58, 95% CI [0.39-0.77]; phone = 0.52, 95% CI [0.39-0.65]) compared to two category NVS (Kappas: in-person = 0.65, 95% CI [0.46-0.85]; phone = 0.64, 95% CI [0.51-0.78]). Correlations decreased as time between administrations increased. Internal consistency was moderately high (baseline NVS in-person (α = 0.76), follow-up NVS in-person (α = 0.76), and phone follow-up (α = 0.78). CONCLUSION: The test-retest properties of the NVS are similar by mode of administration. PRACTICE IMPLICATIONS: This data suggests the NVS measure is reliably administered by telephone.

A Multifaceted Intervention to Improve Patient Knowledge and Safe Use of Opioids: Results of the ED EMC2 Randomized Controlled Trial.

OBJECTIVES: Despite increased focus on opioid prescribing, little is known about the influence of prescription opioid medication information given to patients in the emergency department (ED). The study objective was to evaluate the effect of an Electronic Medication Complete Communication (EMC2 ) Opioid Strategy on patients' safe use of opioids and knowledge about opioids. METHODS: This was a three-arm prospective, randomized controlled pragmatic trial with randomization occurring at the physician level. Consecutive discharged patients at an urban academic ED (>88,000 visits) with new hydrocodone-acetaminophen prescriptions received one of three care pathways: 1) usual care, 2) EMC2 intervention, or 3) EMC2  + short message service (SMS) text messaging. The ED EMC2 intervention triggered two patient-facing educational tools (MedSheet, literacy-appropriate prescription wording [Take-Wait-Stop]) and three provider-facing reminders to counsel (directed to ED physician, dispensing pharmacist, follow-up physician). Patients in the EMC2  + SMS arm additionally received one text message/day for 1 week. Follow-up at 1 to 2 weeks assessed "demonstrated safe use" (primary outcome). Secondary outcomes including patient knowledge and actual safe use (via medication diaries) were assessed 2 to 4 days and 1 month following enrollment. RESULTS: Among the 652 enrolled, 343 completed follow-up (57% women; mean ± SD age = 42 ± 14.0 years). Demonstrated safe opioid use occurred more often in the EMC2 group (adjusted odds ratio [aOR] = 2.46, 95% confidence interval [CI] = 1.19 to 5.06), but not the EMC2  + SMS group (aOR = 1.87, 95% CI = 0.90 to 3.90) compared with usual care. Neither intervention arm improved medication safe use as measured by medication diary data. Medication knowledge, measured by a 10-point composite knowledge score, was greater in the EMC2  + SMS group (ß = 0.57, 95% CI = 0.09 to 1.06) than usual care. CONCLUSIONS: The study found that the EMC2 tools improved demonstrated safe dosing, but these benefits did not translate into actual use based on medication dairies. The text-messaging intervention did result in improved patient knowledge.

Electronic medication complete communication strategy for opioid prescriptions in the emergency department: Rationale and design for a three-arm provider randomized trial.

BACKGROUND: Thousands of people die annually from prescription opioid overdoses; however there are few strategies to ensure patients receive medication risk information at the time of prescribing. OBJECTIVES: To compare the effectiveness of the Emergency Department (ED) Electronic Medication Complete Communication (EMC2) Opioid Strategy (with and without text messaging) to promote safe medication use and improved patient knowledge as compared to usual care. METHODS: The ED EMC2 Opioid Strategy consists of 5 automated components to promote safe medication use: 1) physician reminder to counsel, 2) inbox message sent on to the patient's primary care physician, 3) pharmacist message on the prescription to counsel, 4) MedSheet supporting prescription information, and 5) patient-centered Take-Wait-Stop wording of prescription instructions. This strategy will be assessed both with and without the addition of text messages via a three-arm randomized trial. The study will take place at an urban academic ED (annual volume>85,000) in Chicago, IL. Patients being discharged with a new prescription for hydrocodone-acetaminophen will be enrolled and randomized (based on their prescribing physician). The primary outcome of the study is medication safe use as measured by a demonstrated dosing task. Additionally actual safe use, patient knowledge and provider counseling will be measured. Implementation fidelity as well as costs will be reported. CONCLUSIONS: The ED EMC2 Opioid Strategy embeds a risk communication strategy into the electronic health record and promotes medication counseling with minimal workflow disruption. This trial will evaluate the strategy's effectiveness and implementation fidelity as compared to usual care. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov with identifier NCT02431793.