Search

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Hydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested 2 mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center, non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week preintervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; P < 0.001) and sustained (39.7% to 51.4%, P < 0.001). Mean HbF increased (10.95% to 12.78%; P = 0.03). Self-reported pain frequency reduced (3.54 to 3.35 events/year; P = 0.041). InCharge Health was used ≥1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with ≥1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, P = 0.0045) and weeks 25-36 (1.25 events/patient, P = 0.0015). PDC increased with app use (P < 0.001), with the greatest effect in those with private insurance (P = 0.0078), older subjects (P = 0.033), and those with lower pain interference (P = 0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, 4 unreported), only 11.2% used HU Toolbox ≥1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence can potentially improve adherence and provide clinical benefits. A definitive randomized study is warranted. This trial was registered at www.clinicaltrials.gov as #NCT04080167.

Objective: This study examined the prevalence of food insecurity (FI) among students attending Historically Black Colleges and Universities (HBCUs) in the Southeastern United States. Participants: Students attending four HBCUs (N = 351) completed an anonymous Web-based survey. Methods: Food insecurity was assessed using the 2-item Hunger Vital Sign Tool. Summary statistics were used to quantify FI experiences. Logistic regression was conducted to determine if student demographic characteristics were significantly associated with FI outcomes. Results: Nearly 3 in 4 students (72.9%) reported some level of FI in the past year. Students representing all levels of postsecondary education reported FI. Meal plan participation did not prevent FI. Conclusions: Students attending HBCUs experience FI at levels that exceed estimates reported among students attending predominantly White institutions. More work is needed to understand the lived experience of food-insecure HBCU students as a means to ensure institution-level food policies support student academic success and wellbeing.

Background: The practice of preventive health behaviors, such as regular handwashing, use of hand sanitizers, wearing facemasks in public, and maintaining safe physical distance can help contain the spread of the COVID-19 virus. Purpose: This study aimed to understand factors that influence university students' COVID-19 preventive behaviors by using the social ecological model (SEM). Methods: A total of 112 students shared their experiences with COVID-19 including their preventive behaviors by responding to an open-ended question via Qualtrics. Data were analyzed using thematic analysis. Results: The analysis resulted in various preventive factors across five levels of SEM--perceived responsibility for one's health; lack of health insurance coverage; support of preventive measures for the protection of loved ones; dyad health communication; satisfaction with enforcement measures to protect students by universities; health safety prioritization by employers; downplaying susceptibility to the virus; media hype of the virus; and politicization of the virus and lack of regulations; lack of regulations to mandate precautionary measures; and mistrust of information sources. Translation to Health Education Practice: Since the COVID-19 pandemic is ongoing, the findings of this study can be used by college and university administrators to empower and motivate students to engage in COVID-19 preventive measures.

Background: Farm-to-University (Farm2U) programs make healthy eating accessible, easier, and the default option. Yet, few published studies have focused on Farm2U implementations in Historically Black Colleges and Universities (HBCUs) in conjunction with measurements of implementation barriers using the consolidated framework for implementation research (CFIR). Purpose: The purpose of this study was to assess the feasibility of delivering a Farm2U program in four HBCUs in North Carolina. Methods: Using a quasi-experimental pre-posttest design, four HBCUs were allocated to either the intervention or the control group. The program was administered over a 4-month period and data were collected at baseline and at post-program implementation. Results: With a target sample size of 128, we successfully recruited 351 participants, retaining 138 at follow-up, for a retention rate of 39%. Twelve CFIR constructs were measured, ten emerged as facilitators and two as mixed barriers/facilitators to program implementation. We observed an increase in local produce purchases and a significant increase in the daily intake of fruits for students. Discussion: This study demonstrated that a Farm2U program is feasible in HBCUs. Translation to Health Education Practice: Certified Health Education Specialists can use the findings to implement Farm2U programs that promote healthy food environments in school settings.

BackgroundEpilepsy affects nearly 50 million people worldwide. Self-management is critical for individuals with epilepsy in order to maintain optimal physical, cognitive, and emotional health. Implementing and adopting a self-management program requires considering many factors at the person, program, and systems levels. We conducted a systematic review of qualitative and mixed-methods studies to identify facilitators and barriers that impact implementation and adoption of self-management programs for adults with epilepsy.MethodsWe used established systematic review methodologies for qualitative and mixed-methods studies. We included studies addressing facilitators (i.e., factors that aided) or barriers (i.e., factors that impeded) to implementation and adoption of self-management interventions for adults with epilepsy. We conducted a narrative thematic synthesis to identify facilitators and barriers.ResultsThe literature search identified 2700 citations; 13 studies met eligibility criteria. Our synthesis identified five themes that categorize facilitators and barriers to successful implementation epilepsy self-management: (1) relevance, intervention content that facilitates acquisition of self-management skills; (2) personalization, intervention components that account for the individual's social, physical, and environmental characteristics; (3) intervention components, components and dosing of the intervention; (4) technology considerations, considerations that account for individual's use, familiarity with, and ownership of technology; and (5) clinician interventionist, role and preparation of the individual who leads intervention. We identified facilitators in 11 of the 13 studies and barriers in 11 of the 13 studies and classified these by social-ecological level (i.e., patient/caregiver, program, site/system).ConclusionIdentification of facilitators and barriers at multiple levels provides insight into disease-specific factors that influence implementation and adoption of self-management programs for individuals with epilepsy. Our findings indicate that involving individuals with epilepsy and their caregivers in intervention development, and then tailoring intervention content during the intervention, can help ensure the content is relevant to intervention participants. Our findings also indicate the role of the clinician (i.e., the individual who provides self-management education) is important to intervention implementation, and key issues with clinicians were identified as barriers and opportunities for improvement. Overall, our findings have practical value for those seeking to implement and adopt self-management interventions for epilepsy and other chronic illnesses.Systematic review registrationPROSPERO registration number is CRD42018098604.

Many people with Type 2 diabetes (T2D) who could benefit from digital health technologies (DHTs) are either not using DHTs or do use them, but not for long enough to reach their behavioral or metabolic goals. We aimed to identify subgroups within DHT adopters and non-adopters and describe their unique profiles to better understand the type of tailored support needed to promote effective and sustained DHT use across a diverse T2D population. We conducted latent class analysis of a sample of adults with T2D who responded to an internet survey between December 2021 and March 2022. We describe the clinical and psychological characteristics of DHT adopters and non-adopters, and their attitudes toward DHTs. A total of 633 individuals were characterized as either DHT "Adopters" (n = 376 reporting any use of DHT) or "Non-Adopters" (n = 257 reporting never using any DHT). Within Adopters, three subgroups were identified: 21% (79/376) were "Self-managing Adopters," who reported high health activation and self-efficacy for diabetes management, 42% (158/376) were "Activated Adopters with dropout risk," and 37% (139/376) were "Non-Activated Adopters with dropout risk." The latter two subgroups reported barriers to using DHTs and lower rates of intended future use. Within Non-Adopters, two subgroups were identified: 31% (79/257) were "Activated Non-Adopters," and 69% (178/257) were "Non-Adopters with barriers," and were similarly distinguished by health activation and barriers to using DHTs. Beyond demographic characteristics, psychological, and clinical factors may help identify different subgroups of Adopters and Non-Adopters. [ABSTRACT FROM AUTHOR]

Background Racial and ethnic disparities in genomic testing could exacerbate disparities in access to precision cancer therapies and survival—particularly in the context of lung cancer where genomic testing has been recommended for the past decade. However, prior studies assessing disparities in genomic testing have yielded mixed results. Methods We conducted a systemic review to examine racial and ethnic disparities in the use of genomic testing among lung cancer patients in the United States. Two comprehensive searches in PubMed, Embase, and Scopus were conducted (September 2022, May 2023). Original studies that assessed rates of genomic testing by race or ethnicity were included. Findings were narratively synthesized by outcome. Results The search yielded 2739 unique records, resulting in 18 included studies. All but 1 study were limited to patients diagnosed with non–small cell lung cancer. Diagnosis years ranged from 2007 to 2022. Of the 18 studies, 11 found statistically significant differences in the likelihood of genomic testing by race or ethnicity; in 7 of these studies, testing was lower among Black patients compared with White or Asian patients. However, many studies lacked adjustment for key covariates and included patients with unclear eligibility for testing. Conclusions A majority of studies, though not all, observed racial and ethnic disparities in the use of genomic testing among patients with lung cancer. Heterogeneity of study results throughout a period of changing clinical guidelines suggests that minoritized populations—Black patients in particular—have faced additional barriers to genomic testing, even if not universally observed at all institutions. [ABSTRACT FROM AUTHOR]