Importance Contextualizing care is a process of incorporating information about the life circumstances and behavior of individual patients, termed contextual factors , into their plan of care. In 4 steps, clinicians recognize clues (termed contextual red flags ), clinicians ask about them (probe for context), patients disclose contextual factors, and clinicians adapt care accordingly. The process is associated with a desired outcome resolution of the presenting contextual red flag. Objective To determine whether contextualized clinical decision support (CDS) tools in the electronic health record (EHR) improve clinician contextual probing, attention to contextual factors in care planning, and the presentation of contextual red flags. Design, Setting, and Participants This randomized clinical trial was performed at the primary care clinics of 2 academic medical centers with different EHR systems. Participants were adults 18 years or older consenting to audio record their visits and their physicians between September 6, 2018, and March 4, 2021. Patients were randomized to an intervention or a control group. Analyses were performed on an intention-to-treat basis. Interventions Patients completed a previsit questionnaire that elicited contextual red flags and factors and appeared in the clinician’s note template in a contextual care box. The EHR also culled red flags from the medical record, included them in the contextual care box, used passive and interruptive alerts, and proposed relevant orders. Main Outcomes and Measures Proportion of contextual red flags noted at the index visit that resolved 6 months later (primary outcome), proportion of red flags probed (secondary outcome), and proportion of contextual factors addressed in the care plan by clinicians (secondary outcome), adjusted for study site and for multiple red flags and factors within a visit. Results Four hundred fifty-two patients (291 women [65.1%]; mean [SD] age, 55.6 [15.1] years) completed encounters with 39 clinicians (23 women [59.0%]). Contextual red flags were not more likely to resolve in the intervention vs control group (adjusted odds ratio [aOR], 0.96 [95% CI, 0.57-1.63]). However, the intervention increased both contextual probing (aOR, 2.12 [95% CI, 1.14-3.93]) and contextualization of the care plan (aOR, 2.67 [95% CI, 1.32-5.41]), controlling for whether a factor was identified by probing or otherwise. Across study groups, contextualized care plans were more likely than noncontextualized plans to result in improvement in the presenting red flag (aOR, 2.13 [95% CI, 1.38-3.28]). Conclusions and Relevance This randomized clinical trial found that contextualized CDS did not improve patients’ outcomes but did increase contextualization of their care, suggesting that use of this technology could ultimately help improve outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT03244033
Delta Healthy Sprouts was designed to test the comparative impact of 2 home visiting curricula on weight status, dietary intake, physical activity, and other health behaviors of rural, southern African-American women and their infants. Results pertaining to physical activity outcomes in the gestational period are reported.Eighty-two women, early in their second trimester of pregnancy, were enrolled and randomly assigned to one of 2 treatment arms. Self-reported physical activity was measured 3 times in the gestational period (gestational months 4, 6 and 8). Generalized linear mixed models were used to test for significant treatment, time, and treatment by time effects on weekly minutes of moderate-to-vigorous physical activity (MVPA).Significantly less MVPA was performed at gestational month 8 when compared with gestational month 4 (enrollment) for both treatment arms. Statistically significant effects were not found for treatment or treatment by time interaction.Neither the Parents as Teachers (control) curriculum nor the Parents as Teachers Enhanced intervention proved effective at increasing or maintaining MVPA in this cohort of pregnant women. Lack of adequate physical activity in pregnancy remains an important public health concern, especially given its known health benefits.
(1) Background: There are currently very few interventions performed within a community setting that compare the effects of physical activity (PA) versus PA plus weight loss on cancer and chronic disease risk in older African Americans. Therefore, we investigated the impact of an 8 week (24 session) PA intervention compared to a PA plus weight loss intervention on fat mass, glucose metabolism, and markers of inflammation in older, overweight and obese African Americans. (2) Methods: Subjects were randomized to a PA (n = 83) or PA plus weight loss (n = 72) intervention that met three times weekly for 8 weeks. At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined. (3) Results: Subjects had a mean age of 67 years (SD = 5.3) and were mostly women (88%). The PA plus weight loss group lost more total and visceral fat than the PA group (−4.0% vs. +0.6% and −4.1% vs. +3.7%, respectively, p < 0.01 for both). Changes in inflammation and glucose metabolism were similar between groups post-intervention. Within the PA plus weight loss group only, serum insulin and HOMA-IR decreased significantly. (4) Conclusions: PA combined with weight loss can decrease total and visceral fat mass and improve insulin sensitivity, confirming that these cancer- and chronic disease-related risk factors are influenced by relatively modest lifestyle changes in the short term.
Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n = 82), enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.
Background. Obesity is associated with impaired fasting blood glucose, insulin resistance (IR) and low-grade in- flammation, all of which are risk factors for chronic diseases including type 2 diabetes (T2D). Glucose metabolism and inflammation can be modified with lifestyle changes, although few studies have examined the impact of behav - ioral lifestyle interventions conducted in a “real world” community-based setting on these parameters in overweight and obese older African American (AA) adults with osteoarthritis (OA). The aim of this study was to examine the impact of an 8-week exercise only and 8- week exercise plus dietary weight management intervention on glucose me - tabolism and systemic inflammation in older overweight and obese AA adults with pre-existing lower extremity OA. Methods. Participants were randomized to an 8-week exercise-only (n=59) or exercise plus dietary weight manage - ment (n=48) intervention. Baseline and post-intervention body measures (weight, BMI, and percent body fat) and fasting serum glucose, serum insulin, high sensitivity C-reactive protein and interleukin-6 were assessed. The homeo - static model assessment of insulin resistance (HOMA-IR) was also calculated. Demographic and health-related data were obtained via questionnaire at baseline. Generalized estimating equations to compare changes from baseline ad - justed for BMI and Spearman’s correlation examining the relationship between change in body measures and change in inflammation and glucose metabolism were also examined. Results. The participants were predominately female (86%) with mean age of 67.1 (± 5.6) years and mean BMI of 34 kg/m 2 (95% Confidence Interval: 31.9 – 36.1 kg/m 2 ). Participants in the exercise plus dietary weight management group lost significantly more weight on average than those in the exercise-only group (-2.0 vs. -0.1 kg; p < 0.001). There was no significant between-groups change in markers of inflammation or glucose metabolism, although a clin - ically meaningful 5% (-5.1 mg/dl) decline in glucose from baseline was observed in the exercise plus dietary weight management group. Conclusions. An 8-week exercise plus dietary weight management intervention has potential clinical relevance in regard to improving both body weight and glucose metabolism in a population at elevated risk for T2D and its related complications. Acknowledgements. This work was supported by the National Institute on Aging at NIH (grant number: R01AG039374) and the American Cancer Society Illinois Division (grant number: 261775).
A woman’s diet while pregnant can play an important role in her reproductive health as well as the health of her unborn child. Diet quality and nutrient intake amongst pregnant women residing in the rural Lower Mississippi Delta (LMD) region of the United States is inadequate. The Delta Healthy Sprouts Project was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of women and their infants residing in the LMD region. This paper reports results pertaining to maternal diet quality and nutrient intake in the gestational period. The experimental arm (PATE) received monthly home visits beginning in the second trimester using the Parents as Teachers curriculum enhanced with a nutrition and lifestyle behavior curriculum. The control arm (PAT) received monthly home visits using the Parents as Teachers curriculum only. Maternal diet was assessed via 24-h dietary recall at gestational months (GM) 4 (baseline), 6, and 8. Diet quality was computed using the Healthy Eating Index-2010 (HEI-2010). Gestational period retention rates for PAT and PATE arms were 77 % (33/43) and 67 % (26/39), respectively. Significant effects were not found for time, treatment, or time by treatment for the HEI-2010 total or component scores, macro- or micronutrient intake or percentage of women meeting recommended nutrient intakes. Perhaps due to low participant enrollment and higher than expected rates of drop out and noncompliance, we were not able to demonstrate that the enhanced nutrition and lifestyle curriculum (PATE) intervention had a significant effect on diet quality or nutrient intake during pregnancy in this cohort of rural, Southern, primarily African American women. clinicaltrials.gov, NCT01746394 . Registered 5 December 2012.
Objective: To determine if the use of a simple self-administered Postpartum Questionnaire for Mothers (PQM) at the well-baby visit (WBV) increased the proportion of women who received health care and contraception by 6 months postpartum (PP). Methods: This was a single-site, system-level, intervention. Women were recruited from the pediatric clinic when presenting with their infants for a 2-month WBV. During phase 1 of the study, a control group was enrolled, followed by an 8-week washout period; then enrollment of the intervention group (phase 2). During phase 2, the PQM was administered and reviewed by the pediatrician during the infant's visit; the tool prompted the pediatrician to make a referral for the mother's primary or contraceptive care as needed. Data were collected at baseline and at 6 months PP, and additional data were extracted from the electronic medical record. Results: We found that PP women exposed to the PQM during their infant's WBV were more likely to have had a health care visit for themselves between 2 and 6 months PP, compared with the control group (relative risk [RR] 1.66, [confidence interval (CI) 0.91-3.03]). In addition, at 6 months PP, women in the intervention group were more likely to identify a primary care provider (RR 1.84, [CI 0.98-3.46]), and more likely to report use of long-acting reversible contraception (LARC) (RR 1.24, [CI 0.99-1.58]), compared with women in the control group. Conclusion: A simple self-administered PQM resulted in an increase in women's receipt of health care and use of LARC by 6 months PP. Clinical Trial Registration: Use of a reproductive life planning tool at the pediatric well-baby visit with postpartum women, NCT03448289.
Markers of inflammation and angiogenesis are upregulated in sedentary obese adults with research suggesting that both processes can negatively influence the development of cancer. Conceivably, modulating inflammation and angiogenesis through weight loss (WL) and increased physical activity could prevent or slow the development of cancer. The aim of this ancillary study was to examine the impact of an 8‐week exercise (E) and E+WL intervention on markers of inflammation and angiogenesis in older overweight and obese AA adults enrolled in the NIH Fit & Strong! Plus trial. Fasting blood levels of the inflammatory biomarkers C‐reactive protein, interleukin‐6, and tumor necrosis factor‐α (TNF‐α) and the angiogenic markers vascular endothelial growth factor (VEGF) and osteopontin were assessed at baseline and post‐intervention. Anthropometric and survey data was also obtained. Generalized estimating equations controlling for age, baseline BMI, and gender were used to assess mean post‐intervention change in the biomarkers. 72 subjects were randomized to E+WL and 83 to the E only group . Subjects were predominately female (88%), with a mean age of 67 years old and baseline BMI of 33.8 kg/m 2 . Albeit modest, subjects in the E+WL group lost a greater % of their baseline body weight post‐intervention vs. the E only group (−1.8% vs. −0.2%; p < 0.001). There was no significant difference in the inflammatory or angiogenic markers between the groups post‐intervention. A significant decrease in TNF‐α was observed in the E group only. VEGF was significantly lower post‐intervention in both groups compared to baseline. Post‐intervention changes in markers of inflammation and angiogenesis were minimal in older overweight and obese AA adults following an 8 week E or E+WL intervention. Modest weight loss, short intervention duration, and relatively low intensity physical activities may have impeded our ability to observe significant changes in the majority of markers. The relevance of these interventions for cancer risk reduction deserves further study. Support or Funding Information American Cancer Society Illinois Division #261775; NIH NIA #R01AG039374
