Publications by authors named "Laura M Curtis"

60 Publications

Perceptions of Signs of Addiction Among Opioid Naive Patients Prescribed Opioids in the Emergency Department.

J Addict Med 2021 Feb 5. Epub 2021 Feb 5.

Department of Emergency Medicine, Northwestern University, Chicago, IL (PTS, PML, HSK, DMM); Division of General Internal Medicine and Geriatrics, Department of Medicine, Northwestern University, Chicago, IL (KAC, LAO, LMC, MSW); Department of Emergency Medicine, University of Texas Southwestern, Dallas, TX (DMC).

Objectives: Patient knowledge deficits related to opioid risks, including lack of knowledge regarding addiction, are well documented. Our objective was to characterize patients' perceptions of signs of addiction.

Methods: This study utilized data obtained as part of a larger interventional trial. Consecutively discharged English-speaking patients, age >17 years, at an urban academic emergency department, with a new opioid prescription were enrolled from July 2015 to August 2017. During a follow-up phone interview 7 to 14 days after discharge, participants were asked a single question, "What are the signs of addiction to pain medicine?" Verbatim transcribed answers were analyzed using a directed content analysis approach and double coding. These codes were then grouped into themes.

Results: There were 325 respondents, 57% female, mean age 43.8 years, 70.1% privately insured. Ten de novo codes were added to the 11 DSM-V criteria codes. Six themes were identified: (1) effort spent acquiring opioids, (2) emotional and physical changes related to opioid use, (3) opioid use that is "not needed, (4) increasing opioid use, (5) an emotional relationship with opioids, and (6) the inability to stop opioid use.

Conclusions: Signs of addiction identified by opioid naive patients were similar to concepts identified in medical definitions. However, participants' understanding also included misconceptions, omissions, and conflated misuse behaviors with signs of addiction. Identifying these differences will help inform patient-provider risk communication, providing an opportunity for counseling and prevention.
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http://dx.doi.org/10.1097/ADM.0000000000000806DOI Listing
February 2021

Change in Health Literacy over a Decade in a Prospective Cohort of Community-Dwelling Older Adults.

J Gen Intern Med 2021 Apr 9;36(4):916-922. Epub 2021 Feb 9.

Center for Applied Health Research on Aging (CAHRA), Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA.

Background: Health literacy is often viewed as a static trait in longitudinal studies, which may over or underestimate an individual's ability to manage one's health.

Objectives: We sought to examine health literacy over time among older adults using three widely used measures.

Design: A prospective cohort study.

Participants: Community-dwelling adults ages 55 to 74 at baseline with at least one follow-up visit (N = 656) recruited from one academic internal medicine clinic and six community health centers in Chicago, IL.

Measures: Health literacy was measured using the Test of Functional Health Literacy in Adults (TOFHLA), Newest Vital Sign (NVS), and Rapid Estimate of Adult Literacy in Medicine (REALM) at baseline and up to three follow-up time points.

Results: In unadjusted analyses, significant changes since baseline were found beginning at the second follow-up (mean (M) = 6.0 years, SD = 0.6) for the TOFHLA (M = - 0.9, SD = 0.95, p = 0.049) and the REALM (M = 0.3, SD = 2.5, p = 0.004) and at the last follow-up (M = 8.6 years, SD = 0.5) for the NVS (M = - 0.2, SD = 1.4, p = 0.02). There were non-linear effects of baseline age on TOFHLA and NVS scores over time (piecewise cubic spline p = 0.01 and p < 0.001, respectively) and no effect on REALM scores (B = 0.02, 95% CI - 0.01 to 0.04, p = 0.17) using multivariable mixed-effects linear regression models, controlling for race, education, income, and comorbidity.

Conclusion: We found a negative relationship between age and health literacy over time as measured by the TOFHLA and NVS. Health literacy barriers appear to be more prevalent among individuals in later life, when self-care demands are similarly increasing. Clinicians might consider strategies to assess and respond to limited health literacy, particularly among patients 70 and older. REALM performance remained stable over 10 years of follow-up. This questions whether health literacy tools measure the same attribute. Prospective health literacy studies should carefully consider what measures to use, depending on their objective.
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http://dx.doi.org/10.1007/s11606-020-06423-8DOI Listing
April 2021

Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients.

Contemp Clin Trials 2021 Jan 27;103:106294. Epub 2021 Jan 27.

Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.

Background: Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ('TAKE IT') that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence.

Methods: The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined.

Conclusion: The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.
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http://dx.doi.org/10.1016/j.cct.2021.106294DOI Listing
January 2021

eHealth literacy and web-based patient portal usage among kidney and liver transplant recipients.

Clin Transplant 2021 Feb 16;35(2):e14184. Epub 2020 Dec 16.

Division of Transplantation, Department of Surgery, Emory School of Medicine, Atlanta, GA, USA.

Patient portals promote self-management, but require skills with electronic health information which can be measured by a patient's eHealth literacy. We aimed to describe eHealth literacy among a population of kidney transplant (KT) and liver transplant (LT) recipients and to investigate the relationship between eHealth literacy and Web-based patient portal utilization. We conducted phone surveys (August 2016-March 2017) among 178 KT and 110 LT recipients at two large transplant centers, including the eHealth Literacy Scale (eHEALS) and items assessing routine portal usage. Portal users were defined as routine if usage was every day, weekly, or monthly. The mean eHEALS score was 30.9 (SD: 5.4), and 45.4% routinely used the patient portal more than a few times per month. Routine users had higher eHealth literacy than non-routine users and non-users (31.97 vs. 29.97 vs. 28.20, p < .001). Routine users had higher eHealth literacy scores compared with non-users after adjusting for transplant organ type, age, educational level, employment status, mobile Internet access, and transplant center (OR: 1.10, 95% CI: 1.03-1.17). KT and LT recipients who routinely use patient portals have high eHealth literacy compared with other diseased populations, which should be leveraged by encouraging routine usage to improve post-transplant health and medication adherence.
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http://dx.doi.org/10.1111/ctr.14184DOI Listing
February 2021

Changes in COVID-19 Knowledge, Beliefs, Behaviors, and Preparedness Among High-Risk Adults from the Onset to the Acceleration Phase of the US Outbreak.

J Gen Intern Med 2020 11 1;35(11):3285-3292. Epub 2020 Sep 1.

Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine at Northwestern University, , 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA.

Background: The US outbreak of coronavirus disease 2019 (COVID-19) accelerated rapidly over a short time to become a public health crisis.

Objective: To assess how high-risk adults' COVID-19 knowledge, beliefs, behaviors, and sense of preparedness changed from the onset of the US outbreak (March 13-20, 2020) to the acceleration phase (March 27-April 7, 2020).

Design: Longitudinal, two-wave telephone survey.

Participants: 588 predominately older adults with ≥ 1 chronic condition recruited from 4 active, federally funded studies in Chicago.

Main Measures: Self-reported knowledge of COVID-19 symptoms and prevention, related beliefs, behaviors, and sense of preparedness.

Key Results: From the onset to the acceleration phase, participants increasingly perceived COVID-19 to be a serious public health threat, reported more changes to their daily routine and plans, and reported greater preparedness. The proportion of respondents who believed they were "not at all likely" to get the virus decreased slightly (24.9 to 22.4%; p = 0.04), but there was no significant change in the proportion of those who were unable to accurately identify ways to prevent infection (29.2 to 25.7%; p 0.14). In multivariable analyses, black adults and those with lower health literacy were more likely to report less perceived susceptibility to COVID-19 (black adults: relative risk (RR) 1.62, 95% confidence interval (CI) 1.07-2.44, p = 0.02; marginal health literacy: RR 1.96, 95% CI 1.26-3.07, p < 0.01). Individuals with low health literacy remained more likely to feel unprepared for the outbreak (RR 1.80, 95% CI 1.11-2.92, p = 0.02) and to express confidence in the federal government response (RR 2.11, 95% CI 1.49-3.00, p < 0.001) CONCLUSIONS: Adults at higher risk for COVID-19 continue to lack critical knowledge about prevention. While participants reported greater changes to daily routines and plans, disparities continued to exist in perceived susceptibility to COVID-19 and in preparedness. Public health messaging to date may not be effectively reaching vulnerable communities.
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http://dx.doi.org/10.1007/s11606-020-05980-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462357PMC
November 2020

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.

J Community Health 2020 12;45(6):1149-1157

Division of General Internal Medicine and Geriatrics, Center for Applied Health Research On Aging (CAHRA), Feinberg School of Medicine, Northwestern University, 750 N Lake Shore Dr, 10th Floor, Chicago, IL, 60611, USA.

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.
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http://dx.doi.org/10.1007/s10900-020-00906-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7418091PMC
December 2020

Patient-Reported Opioid Pill Consumption After an ED Visit: How Many Pills Are People Using?

Pain Med 2021 Feb;22(2):292-302

Department of Emergency Medicine, University of Texas Southwestern, Dallas, Texas, USA.

Objectives: Recent guidelines advise limiting opioid prescriptions for acute pain to a three-day supply; however, scant literature quantifies opioid use patterns after an emergency department (ED) visit. We sought to describe opioid consumption patterns after an ED visit for acute pain.

Design: Descriptive study with data derived from a larger interventional study promoting safe opioid use after ED discharge.

Setting: Urban academic emergency department (>88,000 annual visits).

Subjects: Patients were eligible if age >17 years, not chronically using opioids, and newly prescribed hydrocodone-acetaminophen and were included in the analysis if they returned the completed 10-day medication diary.

Methods: Patient demographics and opioid consumption are reported. Opioid use is described in daily number of pills and daily morphine milligram equivalents (MME) both for the sample overall and by diagnosis.

Results: Two hundred sixty patients returned completed medication diaries (45 [17%] back pain, 52 [20%] renal colic, 54 [21%] fracture/dislocation, 40 [15%] musculoskeletal injury [nonfracture], and 69 [27%] "other"). The mean age (SD) was 45 (15) years, and 59% of the sample was female. A median of 12 pills were prescribed. Patients with renal colic used the least opioids (total pills: median [interquartile range {IQR}] = 3 [1-7]; total MME: median [IQR] = 20 [10-50]); patients with back pain used the most (total pills: median [IQR] = 12 [7-16]; total MME: median [IQR] = 65 [47.5-100]); 92.5% of patients had leftover pills.

Conclusions: In this sample, pill consumption varied by illness category; however, overall, patients were consuming low quantities of pills, and the majority had unused pills 10 days after their ED visit.
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http://dx.doi.org/10.1093/pm/pnaa048DOI Listing
February 2021

Cognitive impairment no dementia and associations with health literacy, self-management skills, and functional health status.

Patient Educ Couns 2020 09 12;103(9):1805-1811. Epub 2020 Mar 12.

Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, USA. Electronic address:

Objectives: To determine the prevalence of cognitive impairment no dementia (CIND) among a diverse, community-based population, and establish associations between CIND and health literacy, chronic disease self-management and functional health status.

Methods: 863 primary care adults without dementia aged 55-74. Adjusted logistic and linear regressions were used to assess associations between CIND (None, Mild, Moderate/Severe) and outcomes.

Results: 36 % participants exhibited CIND. It was strongly associated with limited health literacy (Newest Vital Signs: Mild [OR 3.25; 95 % CI 1.93, 5.49], Moderate/Severe [OR 6.45; 95 % CI 3.16, 13.2]; Test of Functional Health Literacy in Adults: Mild [OR 3.46; 95 % CI 2.08, 5.75], Moderate/Severe [OR 8.82; 95 % CI 4.87, 16.0]; all p's < 0.001) and poor chronic disease self-management (Mild [B = -11.2; 95 % CI -13.5, -8.90], Moderate/Severe CI [B = -21.0; 95 % CI -23.6, -18.4]; both p's < 0.001). Associations between CIND and functional health status were non-significant.

Conclusions: CIND was prevalent in this cohort, and strongly associated with requisite skills for managing everyday health needs.

Practice Implications: Attention to subtle declines in chronic disease self-care may assist with CIND identification and care management within this population. When CIND is observed, clinicians should also expect and address difficulties with self-management.
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http://dx.doi.org/10.1016/j.pec.2020.03.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7864102PMC
September 2020

Barriers and solutions to implementing a pragmatic diabetes education trial in rural primary care clinics.

Contemp Clin Trials Commun 2020 Jun 3;18:100550. Epub 2020 Mar 3.

Northwestern University, Department of Preventive Medicine, 680 N. Lake Shore Drive, Chicago, IL, 60611, USA.

Introduction: The purpose of this report is to describe barriers and solutions to the implementation and optimization of a pragmatic trial that tests an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care in rural primary care clinics.

Methods: The two-arm pragmatic trial has been implemented in six rural family medicine clinics in Arkansas. It tests a self-management education and counseling intervention for patients with type 2 diabetes compared to enhanced usual care. Barriers and solutions were identified as issues arose and through interviews with clinic directors and clinic administrators and a focus group, interviews, and tracking reports with clinic health coaches who delivered the intervention.

Results: Barriers to optimizing enrollment, intervention delivery, and data collection were addressed through targeted education of and relationship building with leadership, changing enrollment oversight, and ongoing training of health coaches.

Conclusions: Successful implementation and optimization of this pragmatic clinical trial in rural primary care clinics was achieved through establishing common goals with clinic leadership, minimizing demands on clinic staff and administration, frequent contact and ongoing support of health coaches, and collaborative troubleshooting of issues with delivering the intervention.
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http://dx.doi.org/10.1016/j.conctc.2020.100550DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7068634PMC
June 2020

Prevalence of Universal Medication Schedule prescribing and links to adherence.

Am J Health Syst Pharm 2020 Jan;77(3):196-205

Division of General Internal Medicine, Emory School of Medicine, Atlanta, GA.

Purpose: A Universal Medication Schedule (UMS) that uses explicit language to describe when to take medicine has been proposed as a patient-centered prescribing and dispensing standard. Despite widespread support, evidence of its actual use and efficacy is limited. We investigated the prevalence of UMS instructions and whether their use was associated with higher rates of medication adherence.

Methods: National pharmacy records were analyzed for a cohort of type 2 diabetic adults ≥18 years old (N = 676,739) new to ≥1 oral diabetes medications between January and June 2014. Prescription instructions (N = 796,909) dispensed with medications were classified as UMS or non-UMS. Instructions coded as UMS were further categorized as either providing precise UMS language (tier 1: "take 1 pill at morning, noon, evening, or bedtime") or offering some explicit guidance (tier 2: "take 1 tablet by mouth before breakfast"; tier 3: "take 1 tablet twice daily with a meal"). Adherence over 12 months was measured by proportion of days covered.

Results: One-third of instructions (32.4%, n = 258,508) were classified as UMS (tier 1: 12.6%, n = 100,589; tier 2: 6.0%, n = 47,914; tier 3: 13.8%, n = 110,005). In multivariable analyses, UMS instructions (all tiers) exhibited better adherence compared to non-UMS instructions (relative risk [RR], 1.01; 95% confidence interval [CI], 1.00-1.02; P = 0.01). Patients older than 65 years who were less educated and taking medication more than once daily received greater benefit from tier 1 UMS instructions (RR, 1.14; 95% CI, 1.07-1.21; P < 0.001).

Conclusion: While infrequently used, the UMS could help older, less-educated patients adhere to more complex regimens with minimal investment.
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http://dx.doi.org/10.1093/ajhp/zxz305DOI Listing
January 2020

Longitudinal Investigation of Older Adults' Ability to Self-Manage Complex Drug Regimens.

J Am Geriatr Soc 2020 03 25;68(3):569-575. Epub 2019 Nov 25.

Health Literacy and Learning Program, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

Objectives: We sought to investigate older patients' ability to correctly and efficiently dose multidrug regimens over nearly a decade and to explore factors predicting declines in medication self-management.

Design: Longitudinal cohort study funded by the National Institute on Aging.

Setting: One academic internal medicine clinic and six community health centers.

Participants: Beginning in 2008, 900 English-speaking adults, aged 55 to 74 years, were enrolled in the study, completing a baseline (T1) assessment. To date, 303 participants have completed the same assessment 9 years postbaseline (T4).

Measurements: At T1, subjects were given a standardized, seven-drug regimen and asked to demonstrate how they would take medicine over 24 hours. The number of dosing errors made and times per day that a participant would take medicine were recorded. Health literacy was measured via the Newest Vital Sign, and cognitive decline was measured by the Mini-Mental State Examination.

Results: Participants on average made 2.9 dosing errors (SD = 2.5 dosing errors; range = 0-21 dosing errors) of 21 potential errors at T1 and 5.0 errors (SD = 2.1 errors; range = 1-18 errors; P < .001) at T4. In a multivariate model, limited literacy (β = .69; 95% confidence interval [CI] = .18-1.20; P = .01), meaningful cognitive decline (β = 1.72; 95% CI = .70-2.74; P = .01), number of chronic conditions (β = .21; 95% CI = .07-.34; P = .01), and number of baseline dosing errors (β = -.76; 95% CI = -.85 to -.67; P < .001) were significant, independent predictors of changes in dosing errors. Most patients overcomplicated their daily medication schedule; no sociodemographic characteristics were predictive of poor regimen organization in multivariate models. In a multivariate model, there were no significant predictors of changes in regimen consolidation over time, except regimen consolidation at T1.

Conclusions: Older patients frequently overcomplicated drug regimens and increasingly made more dosing errors over 9 years of follow-up. Patients with limited literacy, cognitive decline, and multimorbidity were at greatest risk for errors. J Am Geriatr Soc 68:569-575, 2020.
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http://dx.doi.org/10.1111/jgs.16255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7056504PMC
March 2020

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

Acad Emerg Med 2019 12 19;26(12):1311-1325. Epub 2019 Nov 19.

Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.

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 (EMC ) 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) EMC intervention, or 3) EMC  + short message service (SMS) text messaging. The ED EMC 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 EMC  + 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 EMC group (adjusted odds ratio [aOR] = 2.46, 95% confidence interval [CI] = 1.19 to 5.06), but not the EMC  + 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 EMC  + SMS group (β = 0.57, 95% CI = 0.09 to 1.06) than usual care.

Conclusions: The study found that the EMC 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.
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http://dx.doi.org/10.1111/acem.13860DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6901720PMC
December 2019

Electronic Health Record-Based Strategy to Promote Medication Adherence Among Patients With Diabetes: Longitudinal Observational Study.

J Med Internet Res 2019 10 21;21(10):e13499. Epub 2019 Oct 21.

Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.

Background: Poor medication adherence is common; however, few mechanisms exist in clinical practice to monitor how patients take medications in outpatient settings.

Objective: This study aimed to pilot test the Electronic Medication Complete Communication (EMC) strategy, a low-cost, sustainable approach that uses functionalities within the electronic health record to promote outpatient medication adherence and safety.

Methods: The EMC strategy was implemented in 2 academic practices for 14 higher-risk diabetes medications. The strategy included: (1) clinical decision support alerts to prompt provider counseling on medication risks, (2) low-literacy medication summaries for patients, (3) a portal-based questionnaire to monitor outpatient medication use, and (4) clinical outreach for identified concerns. We recruited adult patients with diabetes who were prescribed a higher-risk diabetes medication. Participants completed baseline and 2-week interviews to assess receipt of, and satisfaction with, intervention components.

Results: A total of 100 patients were enrolled; 90 completed the 2-week interview. Patients were racially diverse, 30.0% (30/100) had a high school education or less, and 40.0% (40/100) had limited literacy skills. About a quarter (28/100) did not have a portal account; socioeconomic disparities were noted in account ownership by income and education. Among patients with a portal account, 58% (42/72) completed the questionnaire; 21 of the 42 patients reported concerns warranting clinical follow-up. Of these, 17 were contacted by the clinic or had their issue resolved within 24 hours. Most patients (33/38, 89%) who completed the portal questionnaire and follow-up interview reported high levels of satisfaction (score of 8 or greater on a scale of 1-10).

Conclusions: Findings suggest that the EMC strategy can be reliably implemented and delivered to patients, with high levels of satisfaction. Disparities in portal use may restrict intervention reach. Although the EMC strategy can be implemented with minimal impact on clinic workflow, future trials are needed to evaluate its effectiveness to promote adherence and safety.
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http://dx.doi.org/10.2196/13499DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6829279PMC
October 2019

Health Literacy and Income Mediate Racial/Ethnic Asthma Disparities.

Health Lit Res Pract 2019 Jan 18;3(1):e9-e18. Epub 2019 Jan 18.

Background: Health literacy and socioeconomic status (SES) are associated with both race/ethnicity and asthma outcomes. The extent to which health literacy and SES mediate racial/ethnic asthma disparities is less clear.

Objective: To determine if health literacy and SES mediate racial/ethnic asthma disparities using advanced mediation analyses.

Methods: A secondary analysis was performed using a Chicago-based longitudinal cohort study conducted from 2004 to 2007 involving 342 adults age 18 to 41 years with persistent asthma. Phone interviews were conducted every 3 months assessing asthma quality of life (AQOL; scored 1-7, with 7 being the highest) and asthma-related health care use measures. Structural equation models assessed mediation of race/ethnicity effects on AQOL and health care use through health literacy and SES. Covariates in the best-fit model included sex, year and season of interview, and cigarette smoking.

Key Results: The study sample was 77.8% female, 57.3% African American/non-Hispanic, and 28.7% Hispanic. Race/ethnicity was significantly associated with AQOL and asthma-related emergency department (ED) visits, but only indirectly, through the effects of health literacy and income. Compared with White/non-Hispanics, African American/non-Hispanics and Hispanics had significantly higher odds of low health literacy and lower income. Low health literacy was associated with significantly lower AQOL scores (β = -0.24, 95% confidence interval (CI) [-0.38, -0.10]) and higher odds of an ED visit (adjusted odds ratio = 1.24, 95% CI [1.07, 1.43]). Increasing income was associated with significantly higher AQOL scores (β = 0.18, 95% CI [0.08, 0.28]) and lower odds of an ED visit (adjusted odds ratio = 0.88, 95% CI [0.80, 0.97]).

Conclusions: The relationships between race/ethnicity and several asthma outcomes were mediated by health literacy and income. Interventions to improve racial/ethnic asthma disparities should target health literacy and income barriers. .

Plain Language Summary: Using advanced statistical methods, this study suggests racial/ethnic differences in several asthma outcomes are largely due to effects of health literacy and income. Interventions to improve racial/ethnic asthma disparities should target health literacy and income barriers.
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http://dx.doi.org/10.3928/24748307-20181113-01DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6608912PMC
January 2019

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

Pharmacoepidemiol Drug Saf 2019 09 9;28(9):1251-1257. Epub 2019 Jul 9.

Health Literacy and Learning Program, Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, Illinois.

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.
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http://dx.doi.org/10.1002/pds.4795DOI Listing
September 2019

Perceived Adequacy of Tangible Social Support and Associations with Health Outcomes Among Older Primary Care Patients.

J Gen Intern Med 2019 11 26;34(11):2368-2373. Epub 2019 Jun 26.

Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

Background: The availability and adequacy of tangible social support may be critical to older adults managing multiple chronic conditions, yet few studies have evaluated the perceived adequacy of needed tangible support and its relation to health outcomes.

Objective: We investigated the association between unmet, tangible social support needs, health status, and urgent healthcare use among community-dwelling older adults.

Design: Cross-sectional analysis.

Participants: English-speaking older adults (n = 469) who participated in the Health Literacy and Cognitive Function cohort study.

Main Measures: Perceived adequacy of tangible social support was measured using a brief, validated scale that determined (1) if an individual needed assistance managing his or her health, and (2) if yes, whether this need was met. Health status was measured using physical function, depression, and anxiety PROMIS short-form instruments. Urgent healthcare utilization (emergency department and hospitalization) was self-reported for the past 12 months.

Key Results: Participants' mean age was 69 years; 73% were women and 31% were African American, and 16% identified unmet support needs. Unmet support needs were associated with worse physical (β - 6.32; 95% CI - 8.31, - 4.34) and mental health (anxiety: β 3.84; 95% CI 1.51, 6.17; depression: β 2.45; 95% CI 0.32, 4.59) and greater urgent healthcare utilization (ED: OR 2.86; 95% CI 1.51, 5.41; hospitalization: OR 3.75; 95% CI 1.88, 7.50).

Conclusions: Perceived unmet support needs were associated with worse health status and greater urgent healthcare use. Primary care practices might consider screening older patients for unmet tangible support needs, although appropriate responses should first be established if unmet needs are identified.
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http://dx.doi.org/10.1007/s11606-019-05110-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6848542PMC
November 2019

Racial, Ethnic, and Socioeconomic Disparities in Web-Based Patient Portal Usage Among Kidney and Liver Transplant Recipients: Cross-Sectional Study.

J Med Internet Res 2019 04 22;21(4):e11864. Epub 2019 Apr 22.

Department of Medicine, Emory University, Atlanta, GA, United States.

Background: Kidney and liver transplant recipients must manage a complex care regimen after kidney transplant. Although the use of Web-based patient portals is known to improve patient-provider communication and health outcomes in chronic disease populations by helping patients manage posttransplant care, disparities in access to and use of portals have been reported. Little is known about portal usage and disparities among kidney and liver transplant recipients.

Objective: The aim of this study was to examine patient racial/ethnic, socioeconomic, and clinical characteristics associated with portal usage among kidney and liver transplant recipients.

Methods: The study included all adult kidney and liver transplant recipients (n=710) at a large academic transplant center in the Southeastern United States between March 2014 and November 2016. Electronic medical record data were linked with Cerner portal usage data. Patient portal use was defined as any portal activity (vs no activity) recorded in the Cerner Web-based portal, including viewing of health records, lab results, medication lists, and the use of secure messaging. Multivariable log-binomial regression was used to determine the patient demographic, clinical, and socioeconomic characteristics associated with portal usage, stratified by organ.

Results: Among 710 transplant recipients (n=455 kidney, n=255 liver), 55.4% (252/455) of kidney recipients and 48.2% (123/255) of liver recipients used the patient portal. Black patients were less likely to use the portal versus white patients among both kidney (57% black vs 74% white) and liver (28% black vs 55% white) transplant recipients. In adjusted multivariable analyses, kidney transplant recipients were more likely to use the portal if they had higher education; among liver recipients, patients who were white versus black and had higher education were more likely to use the portal.

Conclusions: Despite studies showing that patient portals have the potential to benefit transplant recipients as a tool for health management, racial and socioeconomic disparities should be considered before widespread implementation. Transplant centers should include portal training and support to all patients to encourage use, given its potential to improve outcomes.
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http://dx.doi.org/10.2196/11864DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6658258PMC
April 2019

Who Is Keeping Their Unused Opioids and Why?

Pain Med 2020 01;21(1):84-91

Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Objective: To better understand patients' reasoning for keeping unused opioid pills.

Methods: As part of a larger study, patients were asked their plans for their unused opioids. Responses were categorized as "dispose," "keep," and "don't know." Baseline characteristics were compared between the "keep" and "dispose" groups. Verbatim responses categorized as "keep" were analyzed qualitatively using a team-based inductive approach with constant comparison across cases.

Results: One hundred patients planned to dispose of their pills; 117 planned to keep them. There were no differences in demographics between the groups. Among patients who planned to keep their pills, the mean age was 43 years and 47% were male. Analysis revealed four categories of patient responses: 1) plans to keep their pills "just in case," with reference to a medical condition (e.g., kidney stone); 2) plans to keep pills "just in case" without reference to any medical condition; 3) plans to dispose in delayed fashion (e.g., after pill expiration) or unsure of how to dispose; and 4) no identified plans, yet intended to keep pills. In this sample, there were no differences in characteristics of those reporting planning to keep vs dispose of pills; however, there were diverse reasons for keeping opioids.

Conclusions: This manuscript describes a sample of patients who kept their unused opioids and presents qualitative data detailing their personal reasoning for keeping the unused pills. Awareness of the range of motivations underpinning this behavior may inform the development of tailored education and risk communication messages to improve opioid disposal.
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http://dx.doi.org/10.1093/pm/pnz025DOI Listing
January 2020

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

Patient Educ Couns 2019 04 22;102(4):749-752. Epub 2018 Nov 22.

Department of Emergency Medicine, Feinberg School of Medicine at Northwestern University, Chicago, IL, USA. Electronic address:

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.
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http://dx.doi.org/10.1016/j.pec.2018.11.016DOI Listing
April 2019

Rationale and development of a randomized pragmatic trial to improve diabetes outcomes in patient-centered medical homes serving rural patients.

Contemp Clin Trials 2018 10 20;73:152-157. Epub 2018 Sep 20.

Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Highway, Shreveport, LA 71130-3932, USA.

Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that can be readily implemented and sustained in rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on our team developed an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care that includes: 1) the American College of Physicians (ACP) Diabetes Guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change; 2) a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans'); and 3) a training module for health coaches that prepares them to assume educator/counselor roles with the Diabetes Guide as a teaching tool. While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, its optimal implementation is not known. This project took advantage of a unique opportunity to modify and disseminate the ACP health literacy intervention among patients with type 2 diabetes cared for at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices all had health coaches that could be leveraged to provide chronic disease self-management mostly via phone, but also at the point-of-care. Hence we conducted a patient-randomized, pragmatic clinical trial in 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.
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http://dx.doi.org/10.1016/j.cct.2018.09.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6179446PMC
October 2018

Patient Activation Mediates Health Literacy Associated with Hospital Utilization among Whites.

Health Lit Res Pract 2017 Jul 6;1(3):e128-e135. Epub 2017 Sep 6.

Department of Medicine Boston University School of Medicine, Boston, MA, USA.

Background: Reducing the 30-day hospital readmission rate is a national priority and patient activation has emerged as a modifiable target to reduce hospital readmissions.

Objective: Prior studies demonstrate that low patient activation and low health literacy are each associated with higher rates of hospital utilization. The aim of this study was to use path analysis methods to assess if patient activation mediates the relationship between health literacy and hospital utilization in the 30 days after discharge.

Design And Participants: We performed a secondary analysis of data from a randomized controlled trial of patients receiving care at an urban safety net hospital. Path analyses were used to assess patient activation as a mediator of the relationship of education and health literacy with 30-day hospital utilization. The final model was stratified by race and ethnicity.

Measure: 30 day Hospital Utilization.

Results: In the overall study sample, a one standard deviation (SD) higher patient activation measure (PAM) score was associated with 18% reduced odds of hospital utilization (odds ratio (OR) 0.82, 95% confidence interval (CI): 0.73, 0.91, p=<0.001). PAM mediated the relationship between education level and health literacy and hospital utilization. When stratified by race, the mediating effect of PAM was evident among Whites, but not among non-Whites. Specifically, a one SD higher PAM score was significantly associated with a 33% reduced odds of utilization among Whites (OR 0.67, 95% CI: 0.57, 0.79, p<0.001). With the inclusion of PAM in the model, there was no direct relationship between either health literacy or education and 30-day hospital utilization.

Conclusion: Patient activation is only associated with hospital utilization among Whites. Further research is needed to assess if this selective protection is seen in other cohorts. Potential interventions to reduce hospital readmissions may need to consider other modifiable factors in racially and ethnically diverse populations.
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http://dx.doi.org/10.3928/24748307-20170621-01DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5967226PMC
July 2017

Visual acuity, literacy, and unintentional misuse of nonprescription medications.

Am J Health Syst Pharm 2018 May;75(9):e213-e220

Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL.

Purpose: Results of a study of associations between visual acuity and the risk of misuse of nonprescription acetaminophen products in a sample of community-dwelling adults are reported.

Methods: In a study involving English-speaking adults at 4 primary care clinics, the potential for misuse of nonprescription acetaminophen products was measured via a functional assessment of product self-dosing and by testing patients' understanding of the risks of concomitant use (i.e., taking 2 products at the same time when contraindicated). Vision was assessed using the Rosenbaum vision chart and dichotomized as normal (visual acuity of 20/20-20/25) or low (acuity of 20/30-20/100). Bivariable and multivariable analyses were performed to determine the impact of visual acuity on medication misuse outcomes.

Results: Among the study participants ( = 500), 39% had limited literacy, and 54% were categorized as having low vision. After controlling for age, race, and prior acetaminophen use, low vision was independently associated with an increased risk of self-dosing errors (odds ratio [OR], 1.67; 95% confidence interval [CI], 1.25-2.21; < 0.001) and misunderstanding of concomitant-use risks (OR, 1.41; 95% CI, 1.00-2.00; = 0.05). Limited literacy was an independent risk factor for incorrect dosing (OR, 1.71; 95% CI, 1.25-2.35; = 0.001) and unawareness of concomitant use instructions (OR, 4.14; 95% CI, 2.80-6.12; < 0.001).

Conclusion: Misunderstanding of nonprescription acetaminophen product information was common among study participants and independently associated with both impaired visual acuity and low literacy skills.
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http://dx.doi.org/10.2146/ajhp170303DOI Listing
May 2018

Development and Validation of the Consumer Health Activation Index.

Med Decis Making 2018 04 13;38(3):334-343. Epub 2018 Feb 13.

UnitedHealthcare and UnitedHealth Group, Minneapolis, MN, USA.

Background: Although there has been increasing interest in patient engagement, few measures are publicly available and suitable for patients with limited health literacy.

Objective: We sought to develop a Consumer Health Activation Index (CHAI) for use among diverse patients.

Methods: Expert opinion, a systematic literature review, focus groups, and cognitive interviews with patients were used to create and revise a potential set of items. Psychometric testing guided by item response theory was then conducted among 301 English-speaking, community-dwelling adults. This included differential item functioning analyses to evaluate item performance across participant health literacy levels. To determine construct validity, CHAI scores were compared to scales measuring similar personality constructs. Associations between the CHAI and physical and mental health established predictive validity. A second study among 9,478 adults was used to confirm CHAI associations with health outcomes.

Results: Exploratory factor analyses revealed a single-factor solution with a 10-item scale. The CHAI showed good internal consistency (alpha = 0.81) and moderate test-retest reliability (ICC = 0.53). Reading grade level was found to be at the 6 grade. Moderate to strong correlations were found with similar constructs (Multidimensional Health Locus of Control, r = 0.38, P < 0.001; Conscientiousness, r = 0.41, P < 0.001). Predictive validity was demonstrated through associations with functional health status measures (depression, r = -0.28, P < 0.001; anxiety, r = -0.22, P < 0.001; and physical functioning, r = 0.22, P < 0.001). In the validation sample, the CHAI was significantly associated with self-reported physical and mental health ( r = 0.31 and 0.32 respectively; both P < 0.001).

Conclusions: The CHAI appears to be a valid, reliable, and easily administered tool that can be used to assess health activation among adults, including those with limited health literacy. Future studies should test the tool in actual use and explore further applications.
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http://dx.doi.org/10.1177/0272989X17753392DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6329370PMC
April 2018

Sociodemographic Factors Mediate Race and Ethnicity-associated Childhood Asthma Health Disparities: a Longitudinal Analysis.

J Racial Ethn Health Disparities 2018 10 29;5(5):928-938. Epub 2017 Nov 29.

Boston Medical Center, Boston, MA, USA.

Background: Race and ethnicity-based disparities in childhood asthma are well established. We characterized the longitudinal effects associated with being African-American/Black or Hispanic/Latino on a range of asthma outcomes, and the extent to which sociodemographic factors, caregiver health literacy, education level, and asthma knowledge mediate these associations.

Methods: Children ages 8-15 and their caregivers (n = 544) in the Chicago Initiative to Raise Asthma Health Equity (CHIRAH) cohort completed interviews every 3 months for 1.5 years. Health literacy was measured with the Rapid Estimate of Adult Literacy in Medicine (REALM). Other covariates include sex, age, education level, income, smoke exposure, asthma duration, employment status, and insurance status. We conducted a series of models to evaluate these factors as mediators of the relationship between race/ethnicity and (1) asthma knowledge, (2) asthma-related quality of life, (3) asthma severity, and (4) asthma control based on NAEPP/EPR-3 2007 guidelines.

Results: African-American race and Hispanic/Latino ethnicity were significantly associated with all outcomes when compared to Whites. Adjusting for sociodemographic factors resulted in the most significant mediation of racial/ethnic disparities in all outcomes. Health literacy was a partial mediator of race/ethnic disparities in asthma knowledge and asthma-related quality of life. Asthma knowledge remained significantly associated with race and ethnicity, and race remained associated with asthma-related quality of life.

Conclusions: African-American race and Hispanic/Latino ethnicity are significantly associated with worse asthma compared to Whites in longitudinal analyses. Sociodemographic factors are potent mediators of these disparities, and should be considered when designing interventions to reduce asthma disparities. Health literacy and education level are partial mediators.
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http://dx.doi.org/10.1007/s40615-017-0441-2DOI Listing
October 2018

Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults.

Contemp Clin Trials 2017 11 18;62:21-26. Epub 2017 Aug 18.

Health Literacy and Learning Program, Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.

Background: Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation.

Objective: To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults.

Methods: Older, English or Spanish-speaking patients on complex drug regimens (N=1505) will be recruited from a community health system in Chicago, IL. Enrolled patients will be randomized to one of four study arms, receiving either: 1) enhanced usual care alone; 2) daily medication reminders via SMS text messages; 3) medication monitoring via a patient portal-based assessment; or 4) both SMS text message reminders and portal-based medication monitoring. The primary outcome of the study is medication adherence, which will be assessed via multiple measures at baseline, 2months, and 6months. The effect of intervention strategies on clinical markers (hemoglobin A1c, blood pressure, cholesterol level), as well as intervention fidelity and the barriers and costs of implementation will also be evaluated.

Conclusions: This randomized controlled trial will evaluate the impact of various low-cost intervention strategies on adherence to complex medication regimens and will explore barriers to implementation. If the studied intervention strategies are shown to be effective, then these approaches could be effectively deployed across a diverse range of clinical settings and patient populations.

Clinical Trial Registration: This trial is registered on clinicaltrials.govNCT02820753.
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http://dx.doi.org/10.1016/j.cct.2017.08.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5641260PMC
November 2017

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

Contemp Clin Trials 2017 08 4;59:22-29. Epub 2017 May 4.

Health Literacy and Learning Program, Division of General Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.

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 (EMC) Opioid Strategy (with and without text messaging) to promote safe medication use and improved patient knowledge as compared to usual care.

Methods: The ED EMC 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 EMC 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.
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http://dx.doi.org/10.1016/j.cct.2017.05.003DOI Listing
August 2017

Mild Visual Impairment and Its Impact on Self-Care Among Older Adults.

J Aging Health 2018 03 10;30(3):327-341. Epub 2016 Nov 10.

1 Northwestern University, Chicago, IL, USA.

Objective: To determine the prevalence of mild visual impairment (MVI) among urban older adults in primary care settings, and ascertain whether MVI was a risk factor for inadequate performance on self-care health tasks.

Method: We used data from a cohort of 900 older adults recruited from primary care clinics. Self-management skills were assessed using the Comprehensive Health Activities Scale, and vision with corrective lenses was assessed with the Snellen. We modeled visual acuity predicting health task performance with linear regression.

Results: Normal vision was associated with better overall health task performance ( p = .004). Individuals with normal vision were more likely to recall health information conveyed via multimedia ( p = .02) and during a spoken encounter ( p = .04), and were more accurate in dosing multi-drug regimens ( p = .05).

Discussion: MVI may challenge the performance of self-care behaviors. Health care systems and clinicians should consider even subtle detriments in visual acuity when designing health information, materials, and devices.
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http://dx.doi.org/10.1177/0898264316676406DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139666PMC
March 2018

The electronic medication complete communication (EMC) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

Contemp Clin Trials 2016 11 22;51:72-77. Epub 2016 Oct 22.

Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, Chicago, IL, United States.

Background: Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs.

Objective: To evaluate the effectiveness of the Electronic Medication Complete Communication (EMC) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care.

Methods: The automated EMC Strategy consists of: 1) provider alerts to counsel patients on medication risks, 2) the delivery of patient-friendly medication information via the electronic health record, and 3) an automated telephone assessment to identify potential medication concerns or ADEs. The study will take place in two community health centers in Chicago, IL. Adult, English or Spanish-speaking patients (N=1200) who have been prescribed a high-risk medication will be enrolled and randomized to the intervention arm or usual care based upon practice location. The primary outcomes of the study are medication knowledge, proper medication use, and reporting of ADEs; these will be measured at baseline, 4weeks, and three months. Intervention fidelity as well as barriers and costs of implementation will be evaluated.

Conclusions: The EMC Strategy automates a patient-friendly risk communication and surveillance process to promote safe medication use while minimizing clinic burden. This trial seeks to evaluate the effectiveness and feasibility of this strategy in comparison to usual care.
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http://dx.doi.org/10.1016/j.cct.2016.10.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5108675PMC
November 2016

A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence.

J Gen Intern Med 2016 12 19;31(12):1482-1489. Epub 2016 Aug 19.

Department of Pharmacology, Weill Cornell Medical College, New York, NY, USA.

Background: Patient misunderstanding of prescription drug label instructions is a common cause of unintentional misuse of medication and adverse health outcomes. Those with limited literacy and English proficiency are at greater risk.

Objective: To test the effectiveness of a patient-centered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard.

Design: Two-arm, multi-site patient-randomized pragmatic trial.

Participants: English- and Spanish-speaking patients from eight community health centers in northern Virginia who received prescriptions from a central-fill pharmacy and who were 1) ≥30 years of age, 2) diagnosed with type 2 diabetes and/or hypertension, and 3) taking ≥2 oral medications.

Intervention: A patient-centered label (PCL) strategy that incorporated evidence-based practices for format and content, including prioritized information, larger font size, and increased white space. Most notably, instructions were conveyed with the UMS, which uses standard intervals for expressing when to take medicine (morning, noon, evening, bedtime).

Main Measures: Demonstrated proper use of a multi-drug regimen; medication adherence measured by self-report and pill count at 3 and 9 months.

Key Results: A total of 845 patients participated in the study (85.6 % cooperation rate). Patients receiving the PCL demonstrated slightly better proper use of their drug regimens at first exposure (76.9 % vs. 70.1 %, p = 0.06) and at 9 months (85.9 % vs. 77.4 %, p = 0.03). The effect of the PCL was significant for English-speaking patients (OR 2.21, 95 % CI 1.13-4.31) but not for Spanish speakers (OR 1.19, 95 % CI 0.63-2.24). Overall, the intervention did not improve medication adherence. However, significant benefits from the PCL were found among patients with limited literacy (OR 5.08, 95 % CI 1.15-22.37) and for those with medications to be taken ≥2 times a day (OR 2.77, 95 % CI 1.17-6.53).

Conclusions: A simple modification to pharmacy-generated labeling, with minimal investment required, can offer modest improvements to regimen use and adherence, mostly among patients with limited literacy and more complex regimens. Trial Registration (ClinicalTrials.gov): NCT00973180, NCT01200849.
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http://dx.doi.org/10.1007/s11606-016-3816-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5130952PMC
December 2016