Purpose:With the expansion of telemedicine, patient-centered approaches for delivering diabetes mellitus (DM) self-care education in both in-person and remote settings are needed. A novel Diabetes Survival Skills Toolkit (Kit) (physical toolkit, website, paper guide) was developed, using a user-centered design approach. The aim of this study was to develop a hybrid protocol to assess the perceived usability of the Kit and the skills attainment of its users. Methods:Adults without prior exposure to DM self-care were recruited. User tests were conducted between January 2021 and July 2022. Initially, the usability of the website alone was tested. Then, usability and skills attainment tests were conducted with all 3 components delivered together. Usability was measured by the System Usability Scale (SUS) and skills attainment was measured thorough simulated insulin injection and lancing device use. Results:User tests (N = 43) were conducted remotely (27/43; 63%) and in-person (16/43; 37%). SUS scores were largely excellent (35%) or acceptable (47%). Users who completed skills attainment testing (N = 32) all successfully injected insulin with simulation supplies. However, SUS scores and skills attainment were poorly correlated: users with unacceptable SUS scores (4/32, 13%) successfully attained the tested skills, while 2 of the 3 users who did not demonstrate successful lancing device use had excellent SUS scores. Conclusion:Hybrid user testing of a multi-component Kit to teach DM survival skills showed high skills attainment among adult users new to DM self-care. Pairing usability and skills attainment testing can help optimize the design of DM education interventions.

Background: Patients newly diagnosed with diabetes mellitus (diabetes), who require insulin must acquire diabetes "survival" skills prior to discharge home. COVID-19 revealed considerable limitations of traditional in- person, time-intensive delivery of diabetes education and survival skills training (diabetes survival skills training). Furthermore, diabetes survival skills training has not been designed to meet the specific learning needs of patients with diabetes and their caregivers, particularly if delivered by telehealth. The objective of the study was to identify and understand the needs of users (patients newly prescribed insulin and their caregivers) to inform the design of a diabetes survival skills training, specifically for telehealth delivery, through the application of user-centered design and adult learning and education principles. Methods: Users included patients newly prescribed insulin, their caregivers, and laypersons without diabetes. In semi-structured interviews, users were asked about experienced or perceived challenges in learning diabetes survival skills. Interviews were audio-recorded and transcribed. Investigators performed iterative rounds of coding of interview transcripts utilizing a constant comparative method to identify themes describing the dominant challenges users experienced. Themes were then mapped to adult learning and education principles to identify novel educational design solutions that can be applied to telehealth-based learning. Results: We interviewed 18 users: patients (N = 6, 33 %), caregivers (N = 4, 22 %), and laypersons (N = 8, 44 %). Users consistently described challenges in understanding diabetes survival skills while hospitalized; in preparing needed supplies to execute diabetes survival skills; and in executing diabetes survival skills at home. The challenges mapped to three educational strategies: (1) spiral learning; (2) repetitive goal directed practice and feedback, which have the potential to translate into design solutions supporting remote/virtual learning; and (3) form fits function organizer, which supports safe organization and use of supplies to execute diabetes survival skills independently. Conclusion: Learning complex tasks, such as diabetes survival skills, requires time, repetition, and continued support. The combination of a user-centered design approach to uncover learning needs as well as identification of relevant adult learning and education principles could inform the design of more user-centered, feasible, effective, and sustainable diabetes survival skills training for telehealth delivery.

Objective: Advancements in diagnostics and treatment options for cardiac amyloidosis have improved patient outcomes, yet few patient education materials exist to help patients understand the disease and diagnosis process. We sought to develop and evaluate a set of plain language, patient-centered infographics describing the condition and common diagnostic tests. Methods: Using health literacy best practices, we developed 7 infographics which were further revised based on multilevel stakeholder feedback. To evaluate the materials, we recruited 100 patients from healthcare settings in Chicago, IL; participants completed a web-assisted interview during which they were randomized 1:1 to first view either our infographics or a standard material. Participants completed a knowledge assessment on their assigned material and subsequently reported impressions of both materials. Results: No differences were found between study arms in knowledge. The infographics took significantly less time to read and were more highly rated by participants in terms of appearance and understandability. Over two-thirds of participants preferred the infographics to the standard. Conclusions: The infographics created may improve the learning process about a complex condition and diagnosis process unknown to most adults. Innovation: These infographics are the first of their kind for cardiac amyloidosis and were created using health literacy best practices.

Abstract Disclosure: S.J. Freeman: None. B. Radonski: None. L. Lecka: Employee; Self; Doximity. Stock Owner; Self; Doximity. K. Davis: None. G. Prince: None. K. Carthy: None. J.J. Seley: Speaker; Self; Lifescan Diabetes Institute. J. Song: None. J. Lee: None. S.C. Bailey: Consulting Fee; Self; Merck, Lundbeck, Sanofi-Aventis, Pfizer, Inc., Luto, University of Westminster, Gilead. Grant Recipient; Self; Merck, Eli Lilly & Company, Pfizer, Inc., Lundbeck, Gordon and Betty Moore Foundation, National Institutes of Health, Gilead. R. Khorzad: None. D. Gatchell: None. B. Ankenman: None. D.R. Lewis: Grant Recipient; Self; Pfizer, Inc., Spencer Foundation, National Institutes of Health. J. Holl: None. A. Wallia: Consulting Fee; Self; Eli Lilly & Company. Grant Recipient; Self; Novo Nordisk. Research Investigator; Self; UnitedHealth Group, Eli Lilly & Company. Patient-centered approaches for teaching diabetes mellitus (DM) survival skills are essential. Furthermore, in the peri-COVID era, interventions also need to be amenable to remote care delivery. User-Centered design (UCD) including usability testing is a key strategy to optimize adoption and engagement of interventions. We developed a Diabetes Survival Skills Toolkit (website, paper guide, and a physical Kit with simulation supplies) using UCD (> 50 sessions), followed by administration of system usability surveys (SUS) (scored as unacceptable, acceptable, or excellent) and, in a subset, additional skills testing. Skills testing included simulated blood glucose checks and insulin administration, conducted by 2 trained observers. Forty-three participants with no prior history of DM were recruited between 01/2021-07/2022 to independently learn survival skills using different Toolkit components [website only (N=11), Kit + paper guide (N=28), and Kit + website (N=4)]. Purposive sampling for age and highest education level resulted in 33% being ≥ 65 years and 35% having < 4-year degree. Overall, SUS scores were deemed excellent (N=15/43 [35%]) or acceptable (N=20/43 [47%]). Unacceptable scores were noted in 8/43 (19%) [4 website only (all > 4-year degree) and 4 Kit + paper guide (3 of 4 > 65 years, all < 4-year degree)]. Use of the website alone resulted in a higher rate of unacceptable SUS scores (37%) compared to use of the Kit with either the paper guide or website (13%). SUS-score category was not associated with age (82% acceptable/excellent among <45 years, 86% among 45-64 years, and 79% among >=65 years; Fishers’ p=1.00) nor highest education level (80% acceptable/excellent among <4-year degree and 82% among >=4-year degree; Fisher’s p=0.69). Participants who completed skills testing (N= 28 Kit + paper guide, 4 Kit + website), regardless of their SUS score, all correctly demonstrated the ability to inject insulin with simulation supplies. However, 4/32 (13%) (all SUS scores acceptable/excellent) were unable to navigate all steps independently and 9/32 (28%) (2 SUS unacceptable) did not use the recommended instructional pathway. All 4 participants (3 with > age 65 and < 4-year degree) who completed skills testing but had unacceptable SUS scores still correctly demonstrated the ability to measure blood glucose and inject insulin. In conclusion, a Survival Skills Toolkit, resulted in excellent rates of successful survival skills performance when tested with laypersons of diverse ages and education levels. Subjective usability (SUS scores) did differ among users of different Toolkit components; however, they did not align with actual skill performance. Design preferences and usability tests as well as subsequent skills testing are critical to optimally design tools for diabetes survival skills training. Presentation: Saturday, June 17, 2023

Introduction Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care.Methods and analysis We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to ‘hardwire’ preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18–44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic’s assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects.Ethics and dissemination This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request.Trial registration number ClinicalTrials.gov Registry (NCT04976881).

Objective: To investigate well-being, lifestyle behaviors, self-management capacity and healthcare utilization among adults with chronic conditions at the outbreak of the COVID-19 pandemic. Methods: Data was collected from two interviewer-administered telephone surveys conducted between March 27-May 22, 2020. Participants were patients at Chicago-area clinics. Self-report and validated measures were used for study-related outcomes. Results: A total of 553 participants (age range 23-88) completed data collection at both timepoints. One in five (20.7%) participants experienced stress due to the coronavirus most or all the time and rates of negative well-being were high (WHO-5 Index mean = 58.7%). Almost a quarter (22.3%) engaged in hazardous drinking and 79.7% reported insufficient physical activity. Nearly one in four participants (23.7%) avoided seeking medical care due to worry about COVID-19. In multivariable analyses, greater COVID-19 related stress was associated with less physical activity, lower self-efficacy, greater difficulty managing health and medications, and delays in seeking medical care due to the coronavirus. Conclusions: Mental well-being, lifestyle behaviors, self-management capacity, and healthcare utilization were impacted in the months following the COVID outbreak. Innovation: These findings suggest health systems should implement proactive measures for detecting and treating emotional and behavioral COVID-related concerns.

BACKGROUND:At the onset of the pandemic, there was poor public awareness and inaction in response to COVID-19; it is less known whether this translated to subsequent infections. OBJECTIVES:To explore whether adults who perceived COVID-19 as less of a threat and who were not taking early actions were more likely to become infected over the following year. RESEARCH DESIGN:Survey data from the ongoing (COVID-19 & Chronic Conditions (C3) anonymized for review) cohort study. PARTICIPANTS:Six hundred forty-two adults with a mean age of 63 and ≥1 chronic condition. MEASURES:Self-reported attitudes and behaviors regarding COVID-19 were assessed from March 13 to April 3, 2020, and COVID-19 infection status was captured between May 2020 and January 2021. Bivariate and multivariable analyses examined associations between early perceptions and behaviors with later infection. RESULTS:Approximately 7% reported infection with COVID-19 (N = 46). Adults who perceived the threat of COVID-19 less seriously at the initial outbreak were more likely to test positive over the following year [odds ratio (OR): 0.81, CI: 0.70-0.94; P = 0.006]. Those who were less likely to believe their actions would affect whether they would become infected were more likely to test positive (OR: 0.87, CI: 0.77-0.99; P = 0.03), as were adults who reported not changing their routines (OR: 0.45; CI: 0.24-0.85; P = 0.01). CONCLUSIONS:Adults with delayed responses in acknowledging the threat of COVID-19 and in changing behaviors were more likely to contract the virus. This investigation provides insight into the consequences of inadequate public understanding and response to COVID-19, and it highlights the importance of promoting early awareness among high-risk groups during public health crises.

With pervasive health misinformation and mistrust, many of those at greatest risk from COVID-19 have demonstrated lower vaccine acceptance. In Chicago, IL, surveillance data has revealed lower rates of vaccine uptake among Black and Latinx individuals compared with others. We partnered with two local federally qualified health centers (FQHCs) to develop and implement language-concordant, low literacy patient education materials to promote COVID-19 vaccine knowledge, acceptance, and uptake. Our multi-phase study included: 1) iterative content generation and refinement by health literacy experts, health center providers and staff, and community-dwelling adults; and 2) materials testing via a two-arm randomized experiment among adults from Latinx communities in the Chicagoland area. Results indicate that our English and Spanish-language COVID-19 Fact Sheets increase knowledge about COVID-19 vaccination. These materials are publicly available and can be used by health centers or community organizations to promote COVID-19 vaccination among diverse populations.

ObjectivesTo examine the prevalence of mental health symptoms during the first surge of COVID-19 in the USA, and their associations with COVID-19-related emotional distress, health self-management and healthcare utilisation.DesignCross-sectional analysis of wave 3 (1–22 May 2020) survey data from the ongoing Chicago COVID-19 Comorbidities (C3) study.SettingSeven academic and community health centres in Chicago, Illinois.Participants565 adults aged 23–88 with one or more chronic conditions completing at least one prior C3 study wave.Primary and secondary outcome measuresClinically relevant anxiety and depressive symptoms as measured using Patient-Reported Outcomes Measurement Information System short forms. Self-reported emotional and health-related responses to COVID-19 were measured through a combination of single-item questions and validated measures.ResultsRates of anxiety and depressive symptoms were 14% (81/563) and 15% (84/563), respectively. Anxiety and depressive symptoms were then each separately associated with greater worry about contracting COVID-19 (relative risk (RR) 2.32, 95% CI 1.52 to 3.53; RR 1.67, 95% CI 1.10 to 2.54), greater stress (RR 4.93, 95% CI 3.20 to 7.59; RR 3.01, 95% CI 1.96 to 4.61) and loneliness (RR 3.82, 95% CI 2.21 to 6.60; RR 5.37, 95% CI 3.21 to 8.98), greater avoidance of the doctor (RR 1.62, 95% CI 1.06 to 2.49; RR 1.54, 95% CI 1.00 to 2.36) and difficulty managing health (least square means (LS Means) 6.09, 95% CI 5.25 to 6.92 vs 4.23, 95% CI 3.70 to 4.75; LS Means 5.85, 95% CI 5.04 to 6.65 vs 4.22, 95% CI 3.70 to 4.75) and medications (LS Means 3.71, 95% CI 2.98 to 4.43 vs 2.47, 95% CI 2.02 to 2.92) due to the pandemic.ConclusionsIdentifying and addressing mental health concerns may be an important factor to consider in COVID-19 prevention and management among high-risk medical populations.

The U.S. public health response to coronavirus disease 2019 (COVID-19) has been widely criticized as having downplayed the potential implications COVID-19 could have on one's personal health. Despite the unprecedented threat of COVID-19, many individuals still believed that it was not at all likely that they would become infected. We sought to investigate trends in adults' perceived susceptibility to COVID-19 over the first year of the pandemic, whether distinct trajectories emerged, and if these trajectories differed by participant socio-demographic characteristics. This was a longitudinal cohort study with 5 time points of data collection (March 13, 2020-March 3, 2021). Subjects included 627 adults living with >= 1 chronic conditions, who completed a baseline interview and at least one follow-up interview. In addition to collecting relevant socio-demographic characteristics, participants' perceived susceptibility to COVID-19 across time was assessed and classified into distinct trajectories. Nearly two-thirds (62.2%) of participants perceived themselves to be highly susceptible to COVID-19 from the onset of the pandemic ("early responders") and sustained this over a year, a third (29.0%) eventually perceived themselves to be highly susceptible ("late responders"), and 8.8% maintained a low likelihood of susceptibility throughout the pandemic ("non-responders"). In multivariable analyses, compared to White participants, Latinx participants were significantly more likely to be non-responders and report low likelihood of perceived susceptibility (Risk Ratio [RR]: 3.46; 95% confidence interval: 1.19, 10.1), as were Black participants (RR: 5.49; 95% confidence interval: 2.19, 13.8). A year into the COVID-19 pandemic, 1 out of 11 participants persistently did not think they might be susceptible and potentially infected. Future studies are needed to understand reasons why certain individuals, particularly those of racial/ethnic minorities, did not perceive themselves at risk for infection.

OBJECTIVE:While health podcasts can be effective in reducing stigma and increasing knowledge, we know little about their mechanisms of action. This qualitative study explored the mechanisms of how women connected with the podcast 'menopause: unmuted', which presented menopause information in a storytelling format.METHODS:A diverse sample of 30 women aged 40-60 years were interviewed after listening to the podcast. Interviews covered participant's views and perceptions of the stories presented. Transcripts were analyzed thematically.FINDINGS:Two overarching themes were identified. 'Openness and authenticity' describes the value of personal stories told in an authentic way by real experts-by-experience. 'Relatability and representation' explores participants' emotional reaction to the podcast, influenced by the extent to which they identified with the stories and storytellers on the podcast.CONCLUSIONS:Authenticity and relatability were identified as key mechanisms through which participants connected with audio stories, consistent with Fisher's narrative theory. These findings have important implications for the application of storytelling in podcasts designed to influence health behaviors.PRACTICE IMPLICATIONS:Diverse stories representing a range of demographic characteristics and experiences are needed when creating podcasts about health information to increase listener's relatability and connection.

Most health literacy measures require in-person administration or rely upon self-report. We sought to develop and test the feasibility of a brief, objective health literacy measure that could be deployed via text messaging or online survey. Participants were recruited from ongoing NIH studies to complete a phone interview and online survey to test candidate items. Psychometric analyses included parallel analysis for dimensionality and item response theory. After 9 months, participants were randomized to receive the final instrument via text messaging or online survey. Three hundred six English and Spanish-speaking adults with ≥ 1 chronic condition Thirty-three candidate items for the new measure and patient-reported physical function, anxiety, depression, and medication adherence. All participants previously completed the Newest Vital Sign (NVS) in parent NIH studies. Participants were older (average 67 years), 69.6% were female, 44.3% were low income, and 22.0% had a high school level of education or less. Candidate items loaded onto a single factor (RMSEA: 0.04, CFI: 0.99, TLI: 0.98, all loadings >.59). Six items were chosen for the final measure, named the HL6. Items demonstrated acceptable internal consistency (α=0.73) and did not display differential item functioning by language. Higher HL6 scores were significantly associated with greater educational attainment (r=0.41), higher NVS scores (r=0.55), greater physical functioning (r=0.26), fewer depressive symptoms (r=−0.20), fewer anxiety symptoms (r=−0.15), and fewer barriers to medication adherence (r=−0.30; all p<.01). In feasibility testing, 75.2% of participants in the text messaging arm completed the HL6 versus 66.2% in the online survey arm (p=0.09). Socioeconomic disparities in completion were more common in the online survey arm. The HL6 demonstrates adequate reliability and validity in both English and Spanish. This performance-based assessment can be administered remotely using commonly available technologies with fewer logistical challenges than assessments requiring in-person administration.

Abstract. The U.S. public health response to coronavirus disease 2019 (COVID-19) has been widely criticized as having downplayed the potential implications COVID-19 could have on one's personal health. Despite the unprecedented threat of COVID-19, many individuals still believed that it was not at all likely that they would become infected. We sought to investigate trends in adults’ perceived susceptibility to COVID-19 over the first year of the pandemic, whether distinct trajectories emerged, and if these trajectories differed by participant socio-demographic characteristics. This was a longitudinal cohort study with 5 time points of data collection (March 13, 2020–March 3, 2021). Subjects included 627 adults living with ≥1 chronic conditions, who completed a baseline interview and at least one follow-up interview. In addition to collecting relevant socio-demographic characteristics, participants’ perceived susceptibility to COVID-19 across time was assessed and classified into distinct trajectories. Nearly two-thirds (62.2%) of participants perceived themselves to be highly susceptible to COVID-19 from the onset of the pandemic (“early responders”) and sustained this over a year, a third (29.0%) eventually perceived themselves to be highly susceptible (“late responders”), and 8.8% maintained a low likelihood of susceptibility throughout the pandemic (“non-responders”). In multivariable analyses, compared to White participants, Latinx participants were significantly more likely to be non-responders and report low likelihood of perceived susceptibility (Risk Ratio [RR]: 3.46; 95% confidence interval: 1.19, 10.1), as were Black participants (RR: 5.49; 95% confidence interval: 2.19, 13.8). A year into the COVID-19 pandemic, 1 out of 11 participants persistently did not think they might be susceptible and potentially infected. Future studies are needed to understand reasons why certain individuals, particularly those of racial/ethnic minorities, did not perceive themselves at risk for infection.

BACKGROUND:Mixed methods are valuable in understanding multifaceted health behaviors like medication adherence. Kidney transplant recipients (KTRs) have complex medication regimens and are more vulnerable to nonadherence relative to other transplant recipients. Yet mixed methods have not been widely applied to examine adherence among KTRs, especially in relation to prescribed medications beyond immunosuppressants.OBJECTIVES:As part of a sequential approach, we used in-depth interviews to better understand findings from a previous quantitative study and to describe additional factors that influence prescription medication-taking among adult KTRs.METHODS:Semi-structured interviews were conducted with a purposive sample of 14 adult KTRs recruited from a transplant center in Chicago, IL. Deductive and inductive content analysis was used to code transcripts and identify key themes.RESULTS:Across the sample, we identified insurance challenges, disruptions in routine, and poor mental well-being as barriers to adherence at the patient level. For Black and Hispanic KTRs, poor communication between providers and disjointed care transitions posed additional barriers at the health system level. Compared with White KTRs, Black and Hispanic KTRs experienced greater medication burden due to comorbidities, while medication and digital literacy challenges were unique to Hispanic KTRs.CONCLUSION:KTRs are often motivated to take medications as prescribed, but sometimes lack the capacity or support to do so. Eliciting KTR perspectives is necessary in addressing knowledge and resource gaps at the patient and health system levels to improve adherence. In addition, recognizing the relative burden of taking comorbidity medications compared with immunosuppressants may important, particularly for Black and Hispanic KTRs.

Purpose To assess the relationship between stress regarding COVID-19 and medication adherence. Patients and Methods Older adults with ≥1 chronic condition(s) were recruited from 4 active, federally funded studies in Chicago to participate in a longitudinal telephone survey. Participants self-reported stress regarding COVID-19 in the last week. Adherence was measured via the ASK-12 survey. Results Most participants reported feeling stressed “some of the time” (54.0%), while 18.2% felt stressed “most” or “all of the time” and 27.8% “never” felt stressed. In bivariate analyses, participants who reported being stressed “most” or “all of the time” had worse medication adherence than participants who reported being stressed “some of the time” or “never” (p < 0.001). In multivariable analyses, participants who reported feeling stressed “most” or “all of the time” had worse adherence than those who “never” felt stressed (Adjusted Least Square Mean (Standard Error): 21.3 (0.6) vs 19.7 (0.6), p=0.01). Conclusion Stress due to COVID-19 has significantly impacted medication adherence, which has negative implications for the course of both COVID-19 and comorbid conditions. Healthcare providers should be aware of the potential impact of COVID-19 on patients’ mental and physical well-being and consider ways to routinely assess patient experiences.

Background: Patient-provider communication surrounding menopause symptoms and treatment is often limited. We developed and evaluated a health literacy-appropriate discussion guide to support patient education. Materials and Methods: A cross-sectional randomized study was conducted among 100 English-speaking women, aged 45-60 years, in Chicago, IL, and Durham, NC. Participants were randomly assigned to review either the discussion guide or a standard education material (n = 50 per arm) and to complete an open book knowledge questionnaire; they then rated the appearance and quality of both materials. Bivariate analyses examined knowledge and satisfaction by study arm and across sociodemographic characteristics. Multivariable models tested the effectiveness of the discussion guide to improve knowledge compared with the standard material. Results: Women receiving the discussion guide demonstrated significantly higher knowledge scores compared with those who reviewed the standard material (mean [M] = 20.0, standard deviation [SD] = 2.7, vs. M = 18.1, SD = 2.6; p < 0.001); 82.0% of those exposed to the discussion guide correctly answered ≥85% of knowledge items compared with only 48.0% of those reviewing the standard material (p < 0.001). In multivariable analyses, participants receiving the discussion guide displayed significantly greater knowledge in comparison with those receiving the standard material regardless of whether knowledge was examined as a score (∝ = 1.9, 95% confidence interval [CI]: 0.9-2.9, p < 0.001) or 85% threshold (odds ratio: 5.7, 95% CI: 2.0-16.2, p < 0.001). More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content. Conclusions: The discussion guide improved understanding of menopause symptoms and treatment options in comparison with a current standard and was well received by a diverse audience.

Design of a pragmatic trial requires planning of key components (cohort identification, participant recruitment, consent and enrollment, intervention delivery, and outcomes measurements). The delivery of healthcare was significantly disrupted by COVID-19; this also affected research. We applied health services and outcomes research (HSOR) methods to inform design adaptations of trial components. The trial is an intervention to improve self-care of patients with diabetes mellitus (DM), discharged from the hospital on insulin. Key informant interviews, clinical observations (N=5), patient tracers (N=5), and operational data were gathered from health system stakeholders (N=9), clinicians (N=20), and measurement experts (N=2). Table 1 describes the trial components, HSOR approaches, data sources, and results. A cohort identification algorithm was created using enterprise data warehouse (EDW) data and validated by chart review, and 3 clinical care process maps were produced. Multiple options for each trial component, allowing for flexibility should care disruptions occur, were identified and pretested (N=5). HSOR approaches are effective to rapidly adapt trial design components, even during healthcare delivery disruptions that threaten research. Application of these approaches should be considered as a strategy to design resilient, flexible, and effective pragmatic trials.View largeDownload slideView largeDownload slide DisclosureP. Wax: None. C. Barnard: None. R. T. Ackermann: None. J. L. Holl: None. A. Wallia: Research Support; Self; Eli Lilly and Company, Novo Nordisk, UnitedHealth Group. R. Khorzad: None. C. M. Yu: None. E. K. Touma: None. A. Rosales: None. G. Prince: None. K. Coyne: None. S. Bailey: Consultant; Self; Luto UK, Pfizer Inc., Sanofi US, University of Westminster (UK), Research Support; Self; Eli Lilly and Company, Gordon and Betty Moore Foundation, Lundbeck, Merck & Co., Inc., National Institutes of Health, Pfizer Inc. T. Pollack: None.FundingAgency for Healthcare Research and Quality (3R18HS026143-02S1)