Changing the home visiting research paradigm: models' perspectives on behavioral pathways and intervention techniques to promote good birth outcomes.

BACKGROUND: The US is scaling up evidence-based home visiting to promote health equity in expectant families and families with young children. Persistently small average effects for full models argue for a new research paradigm to understand what interventions within models work best, for which families, in which contexts, why, and how. Historically, the complexity and proprietary nature of most evidence-based models have been barriers to such research. To address this, stakeholders are building the Precision Paradigm, a common framework and language to define and test interventions and their mediators and moderators. This observational study used portions of an early version of the Precision Paradigm to describe models' intended behavioral pathways to good birth outcomes and their stance on home visitors' use of specific intervention technique categories to promote families' progress along intended pathways. METHODS: Five evidence-based home visiting models participated. Model representatives independently completed three structured surveys focused on 41 potential behavioral pathways to good birth outcomes, and 23 behavior change technique categories. Survey data were used to describe and compare models' intended behavioral pathways, explicit endorsement of behavior change technique categories, expectations for home visitors' relative emphasis in using endorsed technique categories, and consistency in endorsing technique categories across intended pathways. RESULTS: Models differed substantially in nearly all respects: their intended pathways to good birth outcomes (range 16-41); the number of technique categories they endorsed in any intended pathway (range 12-23); the mean number of technique categories they endorsed per intended pathway (range 1.5-20.0); and their consistency in endorsing technique categories across intended pathways (22%-100% consistency). Models were similar in rating nearly all behavior change technique categories as at least compatible with their model, even if not explicitly endorsed. CONCLUSIONS: Models successfully used components of the Precision Paradigm to define and differentiate their intended behavioral pathways and their expectations for home visitors' use of specific technique categories to promote family progress on intended pathways. Use of the Precision Paradigm can accelerate innovative cross-model research to describe current models and to learn which interventions within home visiting work best for which families, in which contexts, why and how.

Education and employment outcomes in clients of the Nurse-Family Partnership.

OBJECTIVES: Nurse-Family Partnership (NFP) is an evidence-based home visitation program designed for low-income, first-time mothers to support pregnancy, child development, and maternal self-sufficiency. This study examined educational and employment outcomes among NFP clients compared to a reference sample. DESIGN: Entropy balancing and a difference-in-difference design were used to compare the two samples of women from 2007 to 2016. SAMPLE: There were 127,427 women in the NFP sample, and 787 women in the reference cohort. MEASUREMENTS: Educational outcomes included high school completion and employment outcomes consisted of employment status. RESULTS: Across a one-year interval, NFP mothers with less than a high school diploma or general education diploma (GED) at baseline showed a 9.5 percentage point increase in diploma or GED attainment compared to the reference mothers [95% CI: 0.015-0.180]. Similarly, mothers enrolled in NFP who were not employed at baseline showed a 7.8 percentage point increase in employment compared to the reference mothers [95% CI: 0.003-0.150]. CONCLUSIONS: The findings in this study show positive results for NFP mothers attaining high school completion and employment compared to mothers in the reference group. Such findings are of importance with regard to progression toward economic self-sufficiency and corresponding reduction of health disparities.

Status of High Body Weight Among Nurse-Family Partnership Children.

PURPOSE: Increased prevalence of high levels of body weight in early childhood has become a public health concern, given its potential association with adult obesity and related comorbidities. Both socioeconomic status and race-ethnicity are related to increased prevalence. The purpose of this study was to identify additional risk factors common to children of low-income families; and to guide quality improvement initiatives within home visiting programs, potentially fostering more desirable physical development outcomes. STUDY DESIGN AND METHODS: A cohort of children (n = 14,318) of all mothers enrolled in Nurse-Family Partnership between 2007 and 2010 was evaluated. Measures consisted of demographics, health behaviors, and physical growth metrics collected by specially educated nurses during the course of home visits that also delivered the program model. Measures of weight (W) versus length (L) were converted to percentiles using the Centers for Disease Control and Prevention-World Health Organization norms with high W/L (≥97.7th percentile) defining a binary outcome. Multiple logistic regression modeling was then used to derive risk models for that outcome. RESULTS: Across each of the four time points for body measures (child's age 6, 12, 18, and 24 months), race-ethnicity, prepregnancy body mass index (BMI), maternal weight gain, and breastfeeding duration emerged as common risk factors. CLINICAL IMPLICATIONS: Moderation of weight gain during pregnancy, extending breastfeeding duration, and normalization of BMI before subsequent pregnancies may potentially serve as means of lowering the prevalence of high body weight levels in young children of low-income families served by home visitors.

Status of Birth Outcomes in Clients of the Nurse-Family Partnership.

Background The Nurse-Family Partnership (NFP) is a national, evidence-based home visiting program currently serving over 30,000 first-time, low-income mothers. Prior to public implementation, three foundational randomized controlled trials demonstrated program effectiveness in achieving beneficial birth, child development, and maternal life-course outcomes. This study describes birth outcomes of contemporary NFP clients compared to a reference cohort, providing the first evidence of program effect on a nation-wide basis during scale-up. Methods A cohort of NFP clients beginning the program between 7/1/2007-6/30/2010 was compared to a reference cohort of first-time mothers from publicly available birth data (US Natality Data). Employing propensity score matching, NFP clients (n = 27,195) were each matched to three controls based on maternal age, race-ethnicity, smoking status, education, and marital status. Measures of low birth weight and preterm birth were compared between clients and controls using McNemar's Tests. Results Similar to the foundational trials, no significant difference in low birth weight was observed (NFP 9.4%, matched controls 9.6%, p = 0.20). However, in contrast to the foundational trials, the incidence of preterm births in NFP clients was significantly lower than in matched controls (8.7% vs. 12.3%, respectively; p < 0.0001). Discussion A recent review of NFP birth outcomes employing data pooling techniques (overcoming the statistical power limitations of the original foundational trials) has shown a trend toward a favorable program effect in the incidence of preterm births. The present study provides evidence of such an effect in a well-powered evaluation of recent clients during nation-wide scale-up, with these results meriting further confirmation.

Status of Breastfeeding and Child Immunization Outcomes in Clients of the Nurse-Family Partnership.

Background The Nurse-Family Partnership (NFP) is a home visiting program serving first-time, low-income mothers, with an area of focus on healthy early childhood development. Previous foundational trials of program effect on breastfeeding and immunizations have shown a mix of neutral and positive results. The present evaluation investigates these effects following program scale-up, using a large contemporary cohort of clients. Methods Nurse-Family Partnership client breastfeeding and immunization status were compared to National Survey of Children's Health data and National Immunization Survey data, respectively. Sample differences in demographic covariates were adjusted using logistic regression. Results Nurse-Family Partnership clients were significantly more likely to have ever breastfed (adjusted prevalence ratio [aPR: 1.20 (1.17, 1.23)] and maintain breastfeeding at 6 [aPR: 1.17 (1.10, 1.24)] and 12 [aPR: 1.39 (1.25, 1.53)] months, but less likely to exclusively breastfeed at 6 months [aPR: 0.84 (0.70, 0.95)] NFP clients were significantly more likely to be up-to-date on immunizations at 6 [aPR: 1.23 (1.22, 1.25)], 18 [aPR: 1.33 (1.30,1.35)], and 24 [aPR: 1.15 (1.14, 1.16)] months of age than the reference cohort, with no significant difference at 12 months. Discussion Nurse-Family Partnership clients had more beneficial breastfeeding and immunization outcomes than children of mothers with demographically similar profiles. However, exclusive breastfeeding at 6 months lags behind the reference sample and represents a potential area for further improvement.

Patient navigation improves cancer diagnostic resolution: an individually randomized clinical trial in an underserved population.

BACKGROUND: Barriers to timely resolution of abnormal cancer screening tests add to cancer health disparities among low-income, uninsured, and minority populations. We conducted a randomized trial to evaluate the impact of lay patient navigators on time to resolution and completion of follow-up testing among patients with abnormal screening tests in a medically underserved patient population. METHODS: Denver Health, the safety-net health care system serving Denver, is one of 10 performance sites participating in the Patient Navigation Research Program. Of 993 eligible subjects with abnormal screening tests randomized to navigation and no-navigation (control) arms and analyzed, 628 had abnormal breast screens (66 abnormal clinical breast examinations, 304 BIRADS 0, 200 BIRADS 3, 58 BIRADS 4 or 5) whereas 235 had abnormal colorectal and 130 had abnormal prostate screens. RESULTS: Time to resolution was significantly shorter in the navigated group (stratified log rank test, P < 0.001). Patient navigation improved diagnostic resolution for patients presenting with mammographic BIRADS 3 (P = 0.0003) and BIRADS 0 (P = 0.09), but not BIRADS 4/5 or abnormal breast examinations. Navigation shortened the time for both colorectal (P = 0.0017) and prostate screening resolution (P = 0.06). Participant demographics included 72% minority, 49% with annual household income less than $10,000, and 36% uninsured. CONCLUSIONS: Patient navigation positively impacts time to resolution of abnormal screening tests for breast, colorectal, and prostate cancers in a medically underserved population. IMPACT: By shortening the time to and increasing the proportion of patients with diagnostic resolution patient navigation could reduce disparities in stage at diagnosis and improve cancer outcomes.

Patient navigation for breast and colorectal cancer treatment: a randomized trial.

BACKGROUND: There is limited high-quality evidence about the impact of patient navigation (PN) on outcomes for patients with diagnosed cancer. METHODS: We pooled data from two sites from the national Patient Navigation Research Program. Patients (n = 438) with newly diagnosed breast (n = 353) or colorectal cancer (n = 85) were randomized to PN or usual care. Trained lay navigators met with patients randomized to PN to help them assess treatment barriers and identify resources to overcome barriers. We used intent-to-treat analysis to assess time to completion of primary treatment, psychologic distress (impact of events scale), and satisfaction (patient satisfaction with cancer-related care) within 3 months after initiation of cancer treatment. RESULTS: The sample was predominantly middle-aged (mean age = 57) and female (90%); 44% were race-ethnic minorities (44%), 46% reported lower education levels, 18% were uninsured, and 9% reported a non-English primary language. The randomized groups were comparable in baseline characteristics. Primary analysis showed no statistically significant group differences in time to completion of primary cancer treatment, satisfaction with cancer-related care, or psychologic distress. Subgroup analysis showed that socially disadvantaged patients (i.e., uninsured, low English proficiency, and non-English primary language) who received PN reported higher satisfaction than those receiving usual care (all P < 0.05). Navigated patients living alone reported greater distress than those receiving usual care. CONCLUSIONS: Although the primary analysis showed no overall benefit, the subgroup analysis suggests that PN may improve satisfaction with care for certain disadvantaged individuals. IMPACT: PN for cancer patients may not necessarily reduce treatment time nor distress.

Comparison of physiological response to cardiopulmonary exercise testing among cancer survivors and healthy controls.

Selected physiological responses, including lactate kinetics, to cardiopulmonary exercise testing (CPET) were evaluated among a group of cancer survivors (CS, n = 55) and healthy controls (HC, n = 213). It was uncertain if lactate testing in a group of cancer survivors could provide useful information about training intensity. It was hypothesized that chemotherapy, radiation, surgery, physical inactivity or some combination thereof would alter the normal lactate kinetics (curvilinearity) in the relationship of lactate concentration versus power. Physiologic responses of CS (heart rate, blood pressure, O(2) saturation, RPE, lactate, VO(2peak), and peak power) during cycle ergometry were compared to HC. Comparisons (t tests and Chi-square) were made between the groups and shape of lactate plots were analyzed for determination of a breakpoint. Multiple logistical regressions were then utilized to identify factors related to the inability to determine lactate breakpoints. Lactate breakpoints were common to all but one HC whereas among the CS there was a small subset of subjects (n = 5) who did not show a lactate breakpoint. Group differences indicated that female CS were significantly older, had greater BMI's, and lower work capacity than HC. Males CS had significantly lower work capacity than HC. Multiple logistical regression analyses, in all instances, yielded no statistically significant models predictive of the inability to determine a lactate breakpoint. In this sample of CS and HC, physiological responses and lactate kinetics during CPET were similar while work capacity among the CS was lower. Because lactate breakpoints were found, lactate threshold could be determined for all but a few individuals. For those working with CS, CPET with ECG monitoring and lactate threshold measures should be considered for those wishing for precise and safe training intensities.

Day-to-day variation in plasma interleukin-6 concentrations in older adults.

Interleukin-6 (IL-6) is a pro-inflammatory cytokine commonly used in studies as a means of assessing chronic inflammatory status. Despite the use of plasma IL-6 as a marker of chronic inflammation few studies exist that examine the variability of plasma IL-6 within and between individuals. The purpose of this study was to assess inter- and intra-variability of plasma IL-6 concentration in men and postmenopausal women. Sixteen healthy postmenopausal women and 5 men completed the 2-week study. Fasted venous blood samples were obtained on three consecutive mornings for two consecutive weeks (six blood draws per participant). Mean plasma IL-6 values were 2.00+/-1.74 pg/mL. Intra-variability was not significantly different (p>0.05) however inter-variability was significantly different (p<0.05). The index of individuality (II) was 0.20 and the standard error of the mean (SEM) was determined to equal 0.16 pg/mL (0.32 pg/mL; 1.96 SEM). An II of 0.20 demonstrates the need to carefully evaluate changes in plasma IL-6 concentration instead of utilizing population-based reference norms. In an older adult population until plasma IL-6 differences exceed 0.32 pg/mL such values could be considered normal fluctuation between trials and most likely not attributable to a nutrition intervention.

Effects of soy or milk protein during a high-fat feeding challenge on oxidative stress, inflammation, and lipids in healthy men.

Soy isoflavones may impede atherogenic processes associated with cardiovascular disease. Research suggests that the postprandial generation of TG-rich remnants contributes to the development of atherosclerosis. The purpose of the current study was to determine if 39 g soy (85 mg aglycone isoflavones, treatment) compared with 40 g milk protein (0 mg aglycone isoflavones, control) in combination with a high-fat meal can modify postprandial, atherogenic-associated events and biomarkers for oxidative stress, inflammation, and thrombosis. Fifteen healthy men (20-47 yr) participated in a double-blind cross-over meal-challenge study occurring on two nonconsecutive days. The study meals consisted of two high-fat apple muffins consumed with either a soy or milk shake (229 mL, 41% fat, 41% carbohydrate, and 18% protein). Blood samples were obtained at baseline (fasted) and hours two, four, and six postprandial. Plasma TG significantly increased in both treatment and control meal challenges compared with baseline. There were no significant differences (P > 0.05) between treatment (soy) and control (milk) for ex vivo copper-induced LDL oxidation, serum C-reactive protein, serum interleukin-6 (IL-6), serum fibrinogen, or plasma lipids (total cholesterol, HDL, LDL, TG). IL-6-concentrations significantly decreased as a function of time during either meal challenge (P = 0.005). These data suggest that consumption of soy or milk protein in conjunction with a high-fat meal does not acutely modify postprandial oxidative stress, inflammation, or plasma lipid concentrations in young, healthy men.

Predicted vs measured energy expenditure in critically ill, underweight patients.

A retrospective analysis was conducted to compare 4 energy-prediction equations against measured resting energy expenditure (MREE) determined via indirect calorimetry. Data from a heterogeneous group of 42 critically ill, severely underweight (59.50 +/- 17.30 kg; 77.1 +/- 9.7% ideal body weight [IBW]) male patients were assessed. The Hamwi formula was used to determine IBW. The Harris-Benedict (HB) equation was calculated for patients <90% IBW using both current body weight (CBW) and IBW. Energy needs were also estimated with an Ireton-Jones formula for all mechanically ventilated patients (n = 37). For patients <85% IBW (n = 31), an adjusted body weight was determined ([CBW + IBW]/2) and used in the HB formula. The HB formula using the IBW, CBW, and adjusted body weight was significantly different (p < .05) than MREE. The Ireton-Jones equation was not significantly different (p > .05) from MREE but tended to overestimate energy needs (109.3% +/- 16.8% MREE). Conversely, using the CBW or IBW in the HB underestimated the patient's energy needs; 77.0% +/- 11.6% MREE and 90.9 +/- 16.1% MREE, respectively. For patients <85% IBW, use of the adjusted body weight in the HB represented 84.2% +/- 13.9% MREE. The average caloric need was 31.2 +/- 6.0 kcal/kg CBW. Indirect calorimetry remains the best method of determining a patient's energy needs. Until a large prospective trial is conducted, a combination of prediction equations tempered with clinical judgment and monitoring the appropriateness of the nutrition prescription remains the best approach to quality patient care.