Importance:Patients with diabetes and food insecurity are at greater risk of adverse health outcomes. Effective strategies to promote healthy food access are urgently needed. Objective:To evaluate the effect of a produce prescription (PRx) program on cardiometabolic health outcomes and health care utilization among patients with diabetes who were at risk of food insecurity. Design, Setting, and Participants:This 2-arm, pragmatic, randomized clinical trial was conducted in an integrated academic health system in the southeastern US, and patients were recruited from June to August 2023 and followed up for 12 months. Patients were randomly assigned to be offered a PRx (treatment group) or continued to receive usual care (comparison group). Inclusion criteria included a diabetes diagnosis and being at risk for food insecurity. Randomization was stratified by mean hemoglobin A1c (HbA1c) level during the past year (≥8% vs <8%). Data were analyzed from October 2024 to April 2025. Intervention:The PRx arm received a debit card loaded with $80 monthly for up to 12 months. The card was valid to purchase eligible fresh, frozen, or canned fruits, vegetables, and legumes from grocery retailers. Both arms received diabetes self-management educational materials. Main Outcomes and Measures:Primary outcomes were HbA1c levels and emergency department visits at 12 months following randomization. Secondary outcomes included body mass index, blood pressure, and inpatient visits. Results:Of 9608 patients assessed for eligibility, 2155 provided consent and were randomized and studied. The mean (SD) age was 56 (14) years, 1524 (71%) were female, 112 (5.3%) were Hispanic, 1272 (61%) were non-Hispanic Black, 663 (32%) were non-Hispanic White, and mean (SD) baseline HbA1c levels were 7.48% (1.77%; to convert to the proportion of total hemoglobin, multiply by 0.01). Benefit use was moderate, with only 433 participants (30%) using 80% or more per month. At 12 months, the treatment (n = 1450) and usual care comparison arm (n = 705) participants had an adjusted between-arm difference in HbA1C levels of 0.20 percentage points (95% CI, 0.05%-0.35%), favoring usual care. There were no significant between-group differences in emergency department visits, blood pressure, body mass index, and inpatient visits. Results were similar in the subgroup (n = 651) with elevated HbA1c levels (≥8%). Conclusions and Relevance:This randomized clinical trial found that the PRx program did not improve cardiometabolic health or health care utilization at 12 months. A produce prescription subsidy alone did not improve outcomes among patients with diabetes at risk for food insecurity. Trial Registration:ClinicalTrials.gov Identifier: NCT05896644.
BackgroundSerious illness communication occurs with <10% of outpatients with end-stage liver disease (ESLD), despite high morbidity and mortality. We determined the feasibility of assessing changes in readiness for serious illness communication engagement following an evidence-based intervention.MethodsWe conducted a single group pre-post evaluation of a pilot intervention in adults with ESLD in an outpatient hepatology clinic. Study intervention included a standard outpatient hepatology visit with addition of a serious illness conversation performed by one hepatologist trained in evidence-based communication frameworks. Serious illness communication engagement was measured using a validated survey at baseline and over 6 months. Sociodemographic, clinical information, and post-study qualitative data were collected.Results31 participants enrolled and 22 participants (70.9%) completed the 6-month assessment. The mean age was 53 years, 42% (n = 13) were female, 55% (n = 17) self-identified as non-White and/or Hispanic ethnicity, 60% (n = 18) had more than a high school education, and 65% (n = 20) were not partnered. SIC readiness improved immediately following the SIC intervention (mean 4.0, SD 1.0, P < 0.001), and was maintained at 3 months (mean 4.0, SD 1.1, P < 0.001) and 6 months (mean 3.8, SD 1.3, P = 0.002). Post-study qualitative data showed participants were comfortable with serious illness communication, desired provider initiation and family involvement with a preference for outpatient conversations with a known provider.ConclusionOur hepatologist-led, evidence-based intervention resulted in clinically meaningful and statistically significant increases in serious illness communication readiness for patients with ESLD.
Importance:In 2023, the American Heart Association Cardiovascular-Kidney-Metabolic Scientific Advisory Group introduced the Predicting Risk of Cardiovascular Disease Events (PREVENT) equations, a race-free, sex-specific model for cardiovascular disease (CVD) risk prediction in adults aged 30 to 79 years. While initial validations showed strong performance, their reliability under missingness conditions remains unclear. Objective:To evaluate discrimination and calibration of the PREVENT equations in an electronic health record (EHR) cohort and assess robustness to missingness. Design, Setting, and Participants:This retrospective cohort study used Duke University Health System, a health network encompassing tertiary hospitals, regional hospitals, and primary care practices across North Carolina, EHR data from March 2014 to December 2024 with up to 8 years follow-up. Patients without baseline CVD with sufficient data to calculate PREVENT risk were included. Two cohorts were defined: a relaxed cohort, allowing for missing laboratory and vital sign data with race-sex median imputation, and a strict cohort, restricted to those with complete records. Data were analyzed from October 2024 to June 2025. Exposures:Published PREVENT equations alongside locally fitted Cox proportional hazards, discrete-time neural network, and recalibrated PREVENT models. Main Outcomes and Measures:The primary outcomes were estimated 5-year risk of incident CVD and assessed discrimination (C-index) and calibration (expected vs observed event rates) at 5 years by race, sex, and socioeconomic subgroups. The local adaptation via Duke retraining was compared with machine learning-based recalibration of PREVENT scores. Results:The study included 406 230 patients in the relaxed cohort (239 764 females with a mean [SD] age of 49 [20] years and 166 466 males with a mean [SD] age of 49 [20] years; 16 291 Asian [4.0%], 107 114 Black [26.4%], and 256 403 White [63.1%]) and 127 151 patients in the strict cohort (71 086 females with a mean [SD] age of 54 [13] years and 56 065 males with a mean [SD] age of 53 [12] years; 8210 Asian [6.5%], 29 033 Black [22.8%], and 83 515 White [65.7%]). PREVENT showed strong discrimination in both cohorts (C-index, 0.77 for both males and females in the strict cohort vs 0.75 for males and 0.77 for females in the relaxed cohort), indicating robustness to missing data. Calibration ratios were higher in the strict cohort, indicating more risk underestimation in the relaxed cohort. Local adaptations minimally affected discrimination and modestly improved calibration. Conclusions and Relevance:In this cohort study, the PREVENT equations showed strong discrimination and generalizability, including with missing laboratory and vital sign data when imputation was applied, supporting reliable CVD risk identification and ranking in routine practice.
Mailed stool-based fecal immunochemical testing (FIT) can improve colorectal cancer (CRC) screening rates. We aim to determine whether enhancing communications with evidence-based behavioral economics principles in mailed FIT kits further improves screening rates. This study focused predominantly on Medicare patients at average-risk for colon cancer who were not up-to-date on CRC screening. Patients were randomly assigned to one of two interventions: original communication (a series of standard communications, including a pre-mailing letter, FIT kit and letter, and reminders via text or robo-call); or enhanced communication (the same sequence, but incorporating behavioral economics principles to encourage FIT completion). We compared the rate of FIT tests completed at 90 days and factors associated with completion. 4,070 patients were included. Within 90 days, 27
Patient decision aids (PDAs) are evidence informed tools designed to support patients in the process of making decisions about their health. The International Patient Decision Aid Standards (IPDAS) Collaboration last updated the standards in 2013 and the evidence about patient decision aids has expanded substantially. In this article, we report on an update to IPDAS that used a modified Delphi process with two rounds of voting to reach consensus on evidence informed changes to the criteria. The 202 participants were from 26 countries, and included patients/consumers, policy makers, researchers, and clinician researchers. IPDAS 5.0 includes seven qualifying criteria (necessary to be a patient decision aid), 10 essential criteria (necessary to reduce biased decisions), and 54 enhancing criteria (additional criteria that might improve the quality of a patient decision aid). The updated standards reflect the IPDAS Collaboration's founding goal of providing high quality patient decision aids for patients that minimise potential biases in the decisions made about potential healthcare options.
BACKGROUND:Food insecurity (FI) exacerbates type 2 diabetes (T2D) by limiting access to nutritious foods and worsening glycemic control. Produce prescription (PRx) programs subsidize fruits and vegetables to improve food security and diet quality, yet factors associated with PRx engagement patterns remain understudied. OBJECTIVES:This study aimed to evaluate factors associated with enrollment and benefit use in a PRx program among patients with T2D at risk for FI. METHODS:This observational cohort study analyzed participants from a pragmatic randomized trial in a large integrated health system. Eligible adults (≥18 y) had recent glycated hemoglobin measurements and FI risk based on Medicaid enrollment, high Area Deprivation Index (ADI ≥7), or documented unmet social needs. Of 9644 contacted, 2177 enrolled and were randomly divided 2:1 to receive the EatWell PRx program, receiving a reloadable debit card providing $80/mo for 12 mo to purchase fruits and vegetables. We examined predictors of: 1) study enrollment, 2) any spending (>$0), 3) high spending (>$53/mo median), and 4) highest spending (>$70/mo). Multivariate logistic regression included demographic, socioeconomic, and clinical covariates. RESULTS:Of the 9644 contacted, 2177 enrolled (22.6%), 1450 were assigned to the PRx arm, and 1148 (79.2% of enrollees) activated their cards. Enrollment was lower among older adults [per 10-y increase: odds ratio (OR): 0.75; 95% confidence interval (CI): 0.72, 0.77], males (OR: 0.57; 95% CI: 0.51, 0.63), Medicaid enrollees (OR: 0.61; 95% CI: 0.53, 0.69), high-ADI (OR: 0.62; 95% CI: 0.55, 0.70), and non-Hispanic White (OR: 0.76; 95% CI: 0.68, 0.85) and Hispanic/Latino (OR: 0.72; 95% CI: 0.57, 0.90) participants compared with Black participants. Among card activators, high spending was associated with older age (OR: 1.15; 95% CI: 1.04, 1.27), whereas highest spending was associated with being married (OR: 1.43; 95% CI: 1.03, 1.96) and Black compared with White race (OR: 1.56; 95% CI: 1.09, 2.22). CONCLUSIONS:Demographic and socioeconomic factors are significantly associated with PRx enrollment and utilization. Multimodal outreach strategies and targeted implementation approaches may be necessary to ensure equitable program reach and effectiveness. This trial is registered at clinicaltrials.gov as NCT05896644.
Screening and treatment for unhealthy alcohol use (UAU) and alcohol use disorder (AUD) are recommended but underutilized, particularly in hospital settings. To determine whether a comprehensive screening and treatment protocol for UAU in hospitalized patients can help reduce alcohol use. Quality improvement study at single-center safety-net hospital. 27,914 patients were admitted from 9/2022 to 9/2024, and 18,146 (65.0
Background: Colorectal cancer (CRC) is the second leading cause of cancer mortality worldwide, with the majority of patients diagnosed at advanced stages. Early detection through screenings has been shown to improve morbidity and mortality. Faecal Immunochemical Test (FIT) or Faecal Occult Blood Test (FOBT) are established cost-effective screening modalities for CRC, and patients with an abnormal FIT/FOBT require a follow-up colonoscopy. However, only 32%-56% of patients adhere to their follow-up colonoscopy screening. Our study aims to evaluate 1) interventions targeting colonoscopy completion after an abnormal FIT/FOBT, and 2) the prevalence of colonoscopy completion after an abnormal FIT/FOBT. Methods: We searched MEDLINE, Embase, and Cochrane from inception to May 9, 2026, to identify cohort studies or randomized controlled trials comparing interventions to improve follow-up colonoscopy after an abnormal FIT/FOBT. We computed prevalence and risk ratios (RR) with accompanying 95% confidence Intervals (CIs) for each study and pooled the results using a random-effects meta-analysis. Results: 21 studies (19,625 patients) evaluating interventions to improve colonoscopy completion after an abnormal FIT/FOBT were included. Patient navigation (RR:1.24, 95%CI:1.15-1.34, I2=58.2), patient reminders (RR:1.32, 95%CI:1.04–1.67, I2=89.9), provider reminders (RR:1.36, 95%CI:1.12-1.65, I2=94.4), and automated referrals to gastrointestinal consult (RR:1.68, 95%CI:1.09-2.60, I2=91.9) were effective in increasing follow-up colonoscopy completion with moderate to high heterogeneity detected within and across intervention types. Sensitivity analyses excluding outliers resulted in low heterogeneity for patient navigation, patient reminders (messaging), and provider reminders, while moderate heterogeneity remained for automated referrals. Follow-up colonoscopy increased from 49.6% in controls to 72.7% after interventions. Conclusion: Patient-level and system-level interventions, including patient navigation, patient reminders, and provider reminders, increase completion of follow-up colonoscopy after an abnormal FIT/FOBT. More studies are required to evaluate the efficacy of automated referral to GI consult and to study the incremental effect of each intervention in multicomponent interventions.
OBJECTIVES:This study aimed to investigate the perspectives of international experts and Danish citizens on relevant knowledge about population-based breast, colorectal and cervical cancer screening. METHODS:This was a qualitative interview study with focus group interviews with experts and Danish citizens eligible for breast, colorectal and/or cervical cancer screening. Data were collected using semi-structured interview guides, audio-recorded and transcribed verbatim. A thematic analysis was conducted. RESULTS:Participants were nine international experts from Germany, Canada, the USA, Sweden, the Netherlands and Australia, and 54 citizens from Denmark. Most citizens had 'adequate' or 'problematic' levels of health literacy. Themes that experts and citizens agreed on were: knowledge about the disease and symptoms, practical information about screening, benefits of screening, the option of non-participation and the importance of having numeric information of possible screening outcomes. Experts agreed on the importance of knowledge about the harms of screening, but only a minority of citizens considered this important. CONCLUSIONS:The experts and citizens disagreed on the relevance of knowledge about harms of screening and agreed on other relevant knowledge. PRACTICE IMPLICATIONS:What experts and citizens find important may not align when making informed decisions. Therefore, experts and citizens needs to be involved when developing questionnaires.
Background: Palliative care delivery in oncology is challenging and referral practices vary widely. Standardized, needs-based screening and triage systems are essential to more effectively address patients' palliative care needs. Objective: Assess the feasibility, acceptability, and appropriateness among patients with advanced solid cancers of using electronic patient-reported outcomes (ePROs) to screen for palliative care needs. Design: We developed a 13-item ePRO palliative care survey to assess multidimensional palliative care needs and conducted a pilot study (n = 25) of a palliative care screening intervention using ePRO monitoring and presentation of ePRO reports to a multidisciplinary care team. Feasibility was assessed through enrollment, retention, and ePRO adherence rates. Acceptability and appropriateness were evaluated through exit surveys of all participants and semistructured interviews of a subset of participants (n = 10). Results: From May 2022 to April 2023, 68% (25/37) of eligible patients consented and enrolled on the ePRO platform. Overall, 96% (22/23; 2 censored for death/hospice) of participants completed the study and 96% of participants met predefined ePRO adherence thresholds. Overall, 84% (21/25) of patients reported a severe response during the study period, of whom 95% (20/21) received supportive services during the study period. Patients found the ePRO palliative survey acceptable and appropriate. Qualitative interviews found patient-identified barriers to the intervention and areas for improvement. Conclusions: Screening patients for unmet palliative needs using ePRO monitoring is feasible, acceptable, and appropriate among patients, but more work is needed to understand the perspectives of diverse patients and how to integrate ePRO palliative care screening into clinical workflows.
Introduction: Effective December 2023, North Carolina expanded Medicaid eligibility to cover individuals up to 138% of the Federal Poverty Level. The authors sought to understand the preventive care needs of the newly Medicaid-eligible population. Methods: The authors conducted a repeat cross-sectional analysis using the 2016, 2018, 2020, and 2022 North Carolina Behavioral Risk Factor Surveillance Survey. The authors defined the Medicaid expansion population as those aged 18–64 years with household incomes below 138% Federal Poverty Level and reporting no current source of insurance. The authors compared with those enrolled in traditional Medicaid and all nonelderly adult North Carolinians, evaluating up-to-date use of preventive care services. Survey weights were used to estimate total unmet need. Results: The authors estimated 294,000 individuals in the Medicaid expansion population in 2022. Preventive care use was low for the expansion population in all years. In 2022, 36.7% (27.7%–46.8%) reported having a regular source of care, 40.2% (31.1%–50%) reported a past-year wellness visit, and 45.7% (36.6%–55.2%) reported delaying needed care owing to cost. Among eligible respondents, 28.6% (13.8%–50.2%) were up to date with colorectal cancer screening (vs 49.4% [30.5%–68.4%] for traditional Medicaid and 71% [67.3%–74.4%] for all North Carolina population). It was estimated that 176,000 in the expansion population needed a wellness visit; 186,000 needed a regular care provider; and 66,000 needed 1 or more cancer screening. Conclusions: The North Carolina Medicaid expansion population has a high number of unmet preventive care needs. North Carolina should consider approaches to improve provider capacity for those in Medicaid and promote preventive care and risk reduction for the newly enrolled expansion population.
Introduction Mailed stool testing for colorectal cancer (CRC) may improve screening uptake and reduce the incidence and mortality of CRC, especially among patients at federally qualified health centers (FQHCs). To expand screening programs it is important to identify cost-effective approaches. Methods We developed a decision -analytic model to estimate the cost, effects on screening and patient outcomes (CRCs detected, CRCs prevented, CRC deaths prevented), and cost-effectiveness of implementing a state-wide mailed stool testing program over 5 years among unscreened, age -eligible (aged 50-75 y) patients at FQHCs in Texas. We compared various outreach strategies and organizational structures (centralized, regional, or a hybrid). We used data from our existing regional mailed stool testing program and recent systematic reviews to set parameters for the model. Costs included start-up and ongoing activities and were estimated in 2022 US dollars from the perspective of a hypothetical third -party payer. Cost-effectiveness was assessed by using both incremental and average cost-effectiveness ratios. Results Using either a statewide centralized or hybrid organizational configuration to mail stool tests to newly eligible FQHC patients and patients who have responded at least once since program inception is likely to result in the best use of resources over 5 years, enabling more than 110,000 additional screens, detecting an incremental 181 to 194 CRCs, preventing 91 to 98 CRCs, and averting 46 to 50 CRC deaths, at a cost of $10 million to $11 million compared with no program. Conclusions A statewide mailed stool testing program for FQHC patients can be implemented at reasonable cost with considerable effects on CRC screening outcomes, especially when its structure maximizes program efficiency while maintaining effectiveness.
Background Despite many benefits of end-of-life (EOL) planning, only 1 in 3 adults has EOL documentation, with low rates in resident primary care clinics as well. Objective To increase clinic completion of life-sustaining treatment (LST) notes and advance directives (AD) for veterans at highest risk for death. Methods The setting was a Veterans Affairs (VA) internal medicine primary care clinic. All clinic residents in the 2021-2022 academic year and all clinic patients identified through a VA risk-stratification tool as highest risk for death were included. Baseline AD and LST completion rates were determined through manual chart review. Our interventions included 2 hours of teaching to increase resident knowledge of EOL planning and a systematic process improvement to complete EOL planning appointments. Outcomes assessed included anonymous resident pre- and post-surveys of self-assessed knowledge and comfort with EOL conversations, as well as rates of LST and AD completion determined through serial chart review. Results In the 2021-2022 academic year, 22 residents (100%) and 54 patients were included. Post-intervention surveys (n=22, 100%) showed improved self-assessed knowledge of EOL concepts and comfort with patient discussions (median Likert increase 3 to 4). The number of residents who completed an EOL planning visit increased from 9 of 22 (41%) to 15 (68%). LST completion increased from 9 of 54 (17%) to 29 (54%), and AD completion increased from 18 of 54 (33%) to 33 (61%). Conclusions A brief teaching intervention to prepare residents for comprehensive EOL visits combined with process improvement to offer EOL planning visits improved self-reported knowledge and comfort and completion of EOL visits.
Screening and brief intervention (BI) can reduce risky alcohol use but has not been widely implemented in primary care settings. We sought to implement a screening and telephone-based program within a Federally Qualified Health Center (FQHC). Prior to this program, adult patients were routinely screened using AUDIT-C with no further systematic follow-up. We designed a team-based, tele-care-centered program to (1) follow-up positive screening results or provider referrals with full AUDIT and (2) provide a social worker-administered two-session BI for patients with AUDIT 4–12; those with high AUDIT scores received BI and were offered pharmacotherapy and/or referral for additional support. Repeat AUDIT was administered at 3–6 months. From March 2021 to May 2023, 3959 patients were screened using AUDIT-C, with 632 (16
Clinical practice guidelines recommend screening for primary hyperaldosteronism (PH) in patients with resistant hypertension. However, screening rates are low in the outpatient setting. We sought to increase screening rates for PH in patients with resistant hypertension in our Veterans Affairs (VA) outpatient resident physician clinic, with the goal of improving blood pressure control. Patients with possible resistant hypertension were identified through a VA Primary Care Almanac Metric query, with subsequent chart review for resistant hypertension criteria. Three sequential patient-directed cycles were implemented using rapid cycle improvement methodology during a weekly dedicated resident quality improvement half-day. In the first cycle, patients with resistant hypertension had preclinic PH screening labs ordered and were scheduled in the clinic for hypertension follow-up. In the second cycle, patients without screening labs completed were called to confirm medication adherence and counselled to screen for PH. In the third cycle, patients with positive screening labs were called to discuss mineralocorticoid receptor antagonist (MRA) initiation and possible endocrinology referral. Of 97 patients initially identified, 58 (60%) were found to have resistant hypertension while 39 had pseudoresistant hypertension from medication non-adherence. Of the 58 with resistant hypertension, 44 had not previously been screened for PH while 14 (24%) had already been screened or were already taking an MRA. Our screening rate for PH in resistant hypertension patients increased from 24% at the start of the project to 84% (37/44) after two cycles. Of the 37 tested, 24% (9/37) screened positive for PH, and 5 patients were started on MRAs. This resident-led quality improvement project demonstrated that a focused intervention process can improve PH identification and treatment.
Importance:Most of the rapid increase in cutaneous melanoma incidence in the US has been localized disease that is treated surgically and is associated with high survival rates. However, little is known about the psychological well-being of survivors in the US. Objective:To explore the lived experiences and fear of cancer recurrence among survivors of localized cutaneous melanoma. Design, Setting, and Participants:This was a qualitative and survey-based study that used semistructured interviews and the Fear of Cancer Recurrence Inventory short form (FCRI-SF) survey tool with participants recruited from an academic dermatology practice affiliated with the University of Texas, Austin. Interviews were completed via telephone or in person from August 2021 to September 2022. Each of the 9 items in the FCRI-SF was rated on a 5-point Likert scale, scored from 0 to 4, with a maximum possible score of 36 points. Data analyses were performed from February 2022 to June 2023. Main Outcomes and Measures:Semistructured interviews were analyzed for themes and subthemes associated with the lived experiences of survivors of cutaneous melanoma. The FCRI-SF scores were tabulated, with scores of 13 or greater identifying potential cases of clinically significant fear of cancer recurrence. Results:In all, 51 participants (mean [SD] age, 49.5 [11.7] years; 34 [67%] female and 17 [33%] male) with a history of localized melanoma (stage 0-IIA) completed the interview and survey. Among them, 17 (33%) had survived a diagnosis of stage 0 melanoma, and the remainder, at least 1 invasive melanoma diagnosis (stage I-IIA). Semistructured interviews revealed several themes: (1) emotions surrounding follow-up appointments, (2) intensity of melanoma surveillance, (3) lifestyle changes regarding sun exposure, and (4) thoughts about life and death. Thirty-eight of 51 participants had an FCRI-SF score above the threshold for clinical fear of cancer recurrence. Conclusions and Relevance:This qualitative and survey-based study found that despite having an excellent prognosis, some survivors of localized melanoma, even those who had stage 0, have high rates of fear of cancer recurrence and intense survivorship experiences that affect their psychological well-being.