Effect of a Standard vs Enhanced Implementation Strategy to Improve Antibiotic Prescribing in Nursing Homes: A Trial Protocol of the Improving Management of Urinary Tract Infections in Nursing Institutions Through Facilitated Implementation (IMUNIFI) Study.

Importance: Suspicion of urinary tract infection (UTI) is the major driver of overuse and misuse of antibiotics in nursing homes (NHs). Effects of interventions to improve the recognition and management of UTI in NHs have been mixed, potentially owing to differences in how interventions were implemented in different studies. An improved understanding of how implementation approach influences intervention adoption is needed to achieve wider dissemination of antibiotic stewardship interventions in NHs. Objective: To compare the effects of 2 implementation strategies on the adoption and effects of a quality improvement toolkit to enhance recognition and management of UTIs in NHs. Design, Setting, and Participants: This cluster-randomized hybrid type 2 effectiveness-implementation clinical trial will be performed over a 6-month baseline (January to June 2019) and 12-month postimplementation period (July 2019 to June 2020). A minimum of 20 Wisconsin NHs with 50 or more beds will be recruited and randomized in block sizes of 2 stratified by rurality (rural vs urban). All residents who are tested and/or treated for UTI in study NHs will be included in the analysis. All study NHs will implement a quality improvement toolkit focused on enhancing the recognition and management of UTIs. Facilities will be randomized to either a usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback. Enhanced implementation is hypothesized to be associated with improvements in adoption of the quality improvement toolkit and clinical outcomes. Primary outcomes of the study will include number of (1) urine cultures per 1000 resident days and (2) antibiotic prescriptions for treatment of suspected UTI per 1000 resident-days. Secondary outcomes of the study will include appropriateness of UTI treatments, treatment length, use of fluoroquinolones, and resident transfers and mortality. A mixed-methods evaluation approach will be used to assess extent and determinants of adoption of the UTI quality improvement toolkit in study NHs. Discussion: Knowledge gained during this study could help inform future efforts to implement antibiotic stewardship and quality improvement interventions in NHs. Trial Registration: ClinicalTrials.gov identifier: NCT03520010.

Feeling Loved: A Novel Brief Self-Report Health Measure.

CONTEXT: There is need for a short validated self-report instrument for assessing the feeling of being loved. The Feeling Loved instrument asks: "Do you feel loved?" and "How loved do you feel?" as well as "Do you love yourself?" and "How much do you love yourself?" with 100 mm visual analogue scales assessing the continuous response options. OBJECTIVE: To assess convergent and discriminant validity and to explore psychometric structure for this novel self-report measure. DESIGN: Convergent validity comparators include: general mental health, perceived social support, perceived stress, depressive symptoms, and positive/negative emotion. Discriminant validity comparators include: gender, age, ethnicity, socioeconomic status, and body mass index. Latent class analysis techniques explore psychometric structure. SETTING: Baseline evaluation for a randomized controlled trial. PARTICIPANTS: Community-recruited adults in Madison, Wisconsin. INTERVENTION: This validation study is based on pre-intervention data. MAIN OUTCOME MEASURES: Strength of correlation with comparators is used to assess convergence and discrimination. Goodness-of-fit indicators assess latent class models. RESULTS: Of n = 412 respondents, 92% answered positively to both Yes/No questions, and 59% self-rated ≥75/100 on both 0-to-100 VAS scales. Supporting convergent validity, highly significant (p < 0.001) Spearman's rho=ρ correlations of a summed Feeling Loved score were: mental health (ρ = 0.49); social support (ρ = 0.46); perceived stress (ρ = -0.46), depressive symptoms (ρ = -0.31), and both positive (ρ = 0.50) and negative (ρ = -0.43) emotion. Significant associations were also found for personality indicators. Supporting discriminant validity, Feeling Loved scores did not correlate significantly with physical health (ρ = -0.08), body mass index (ρ = 0.01), age (ρ = 0.06), or income (ρ = 0.07) (p values all ≥ 0.12). Latent class analysis models suggested a 3-class structure, with strong goodness-of-fit indicators.

What do visitors know and how do they feel about contact precautions?

Patients with Clostridium difficile infection (CDI) are placed in contact precautions. We surveyed 31 visitors of CDI patients to understand their compliance, knowledge, and perceptions of contact precautions. Although most visitors knew where to find the required personal protective equipment, only 42% were fully compliant with gown and gloves. Family members accounted for 90% of visitors, and roughly half of the reasons given for not gowning were related to a lack of perceived risk for family members. Nursing staff are fundamental sources of personal protective equipment (PPE) information for visitors; however, we found variation in staff communication regarding need for visitor PPE use.

Changes to physician and nurse time burdens when caring for patients under contact precautions.

Contact precautions are complex behavioral interventions. To better understand barriers to compliance, we conducted a prospective study that compared the time burden for health care workers caring for contact precautions patients versus other patients. We found that nurses spent significantly more time in the rooms of contact precautions patients. There was no significant change in physician timing. Future studies need to evaluate workflow changes so that barriers to contact precaution implementation can be fully understood and addressed.

Serum IFN-γ-induced protein 10 (IP-10) as a biomarker for severity of acute respiratory infection in healthy adults.

BACKGROUND: The inflammatory chemokine, interferon-gamma inducible protein of 10kDa (IP-10), is a biomarker associated with several conditions. OBJECTIVES: This study investigated serum concentrations of IP-10 in healthy individuals who developed acute respiratory infection (ARI). The hypothesis is that serum IP-10 concentrations correlate with ARI severity and detection of viral pathogens. STUDY DESIGN: Data come from a randomized controlled trial measuring the effects of mindfulness meditation or exercise on ARI (Clinical Trials ID: NCT01654289). Healthy adults ages 30-69 were followed for a single season for ARI incidence and severity. This trial is ongoing, and the investigators are still blinded. When a participant reported ARI symptoms, nasal swab and lavage for PCR-based viral identification and blood samples were collected within the first 72h of ARI symptoms. Serum IP-10 concentrations were measured by ELISA (R&D Systems, Inc., Quantikine ELISA, Minneapolis, MN). ARI severity was measured using the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24) until the ARI episode resolved. RESULTS: Serum IP-10 concentrations from 225 ARI episodes correlated with ARI global severity (rho 0.28 [95% CI: 0.15-0.39]; p<0.001). IP-10 concentrations were higher with an ARI in which a viral pathogen was detected compared to no viral pathogen detected (median 366pg/ml [IQR: 227-486] vs 163pg/ml [IQR: 127-295], p<0.0001). Influenza infections had higher IP-10 concentrations than coronavirus, enterovirus or rhinovirus, and paramyxovirus. CONCLUSION: Serum IP-10 concentration correlates with ARI global severity. Also, IP-10 concentration measured early in the course of the ARI correlates with the daily severity, duration, and illness symptoms.

Self-Reported Mental Health Predicts Acute Respiratory Infection.

BACKGROUND: Poor mental health conditions, including stress and depression, have been recognized as a risk factor for the development of acute respiratory infection. Very few studies have considered the role of general mental health in acute respiratory infection occurrence. The aim of this analysis is to determine if overall mental health, as assessed by the mental component of the Short Form 12 Health Survey, predicts incidence, duration, or severity of acute respiratory infection. METHODS: Data utilized for this analysis came from the National Institute of Health-funded Meditation or Exercise for Preventing Acute Respiratory Infection (MEPARI) and MEPARI-2 randomized controlled trials examining the effects of meditation or exercise on acute respiratory infection among adults aged > 30 years in Madison, Wisconsin. A Kendall tau rank correlation compared the Short Form 12 mental component, completed by participants at baseline, with acute respiratory infection incidence, duration, and area-under-the-curve (global) severity, as assessed by the Wisconsin Upper Respiratory Symptom Survey. RESULTS: Participants were recruited from Madison, Wis, using advertisements in local media. Short Form 12 mental health scores significantly predicted incidence (P = 0.037) of acute respiratory infection, but not duration (P = 0.077) or severity (P = 0.073). The Positive and Negative Affect Schedule (PANAS) negative emotion measure significantly predicted global severity (P = 0.036), but not incidence (P = 0.081) or duration (P = 0.125). Mindful Attention Awareness Scale scores significantly predicted incidence of acute respiratory infection (P = 0.040), but not duration (P = 0.053) or severity (P = 0.70). The PHQ-9, PSS-10, and PANAS positive measures did not show significant predictive associations with any of the acute respiratory infection outcomes. CONCLUSION: Self-reported overall mental health, as measured by the mental component of Short Form 12, predicts acute respiratory infection incidence.

Age and psychological influences on immune responses to trivalent inactivated influenza vaccine in the meditation or exercise for preventing acute respiratory infection (MEPARI) trial.

BACKGROUND: Strategies to improve influenza vaccine protection among elderly individuals are an important research priority. Mindfulness-based stress reduction (MBSR) and exercise have been shown to affect aspects of immune function in some populations. We hypothesized that influenza vaccine responses may be enhanced with meditation or exercise training as compared with controls. RESULTS: No differences in vaccine responses were found comparing control to MBSR or exercise. Individuals achieving seroprotective levels of influenza antibody ≥160 units had higher optimism, less anxiety, and lower perceived stress than the nonresponders. Age correlated with influenza antibody responses, but not with IFNγ or IL-10 production. CONCLUSION: The MBSR and exercise training evaluated in this study failed to enhance immune responses to influenza vaccine. However, optimism, perceived stress, and anxiety were correlated in the expected directions with antibody responses to influenza vaccine. METHODS: Healthy individuals≥50 y were randomly assigned to exercise (n=47) or MBSR (n=51) training or a waitlist control condition (n=51). Each participant received trivalent inactivated influenza vaccine after 6 weeks, and had blood draws prior to and 3 and 12 weeks after immunization. Serum influenza antibody, nasal immunoglobulin A, and peripheral blood mononuclear cell interferon-γ (IFNγ) and interleukin-10 (IL-10) concentrations were measured. Measures of optimism, perceived stress, and anxiety were obtained over the course of the study. Seroprotection was defined as an influenza antibody concentration≥160 units. Vaccine responses were compared using ANOVA, t tests, and Kruskal-Wallis tests. The correlation between vaccine responses and age was examined with the Pearson test.

Randomized controlled trial of mindfulness meditation and exercise for the prevention of acute respiratory infection: possible mechanisms of action.

Background. A randomized trial suggests that meditation and exercise may prevent acute respiratory infection (ARI). This paper explores potential mediating mechanisms. Methods. Community-recruited adults were randomly assigned to three nonblinded arms: 8-week mindfulness-based stress reduction (N = 51), moderate-intensity exercise (N = 51), or wait-list control (N = 52). Primary outcomes were ARI illness burden (validated Wisconsin Upper Respiratory Symptom Survey). Potential mediators included self-reported psychophysical health and exercise intensity (baseline, 9 weeks, and 3 months). A Baron and Kenny approach-based mediational analysis model, adjusted for group status, age, and gender, evaluated the relationship between the primary outcome and a potential mediator using zero-inflated modeling and Sobel testing. Results. Of 154 randomized, 149 completed the trial (51, 47, and 51 in meditation, exercise, and control groups) and were analyzed (82% female, 94% Caucasian, 59.3 ± SD 6.6 years old). Mediational analyses suggested that improved mindfulness (Mindful Attention Awareness Scale) at 3 months may mediate intervention effects on ARI severity and duration (P < 0.05); 1 point increase in the mindfulness score corresponded to a shortened ARI duration by 7.2-9.6 hours. Conclusions. Meditation and exercise may decrease the ARI illness burden through increased mindfulness. These preliminary findings need confirmation, if confirmed, they would have important policy and clinical implications. This trial registration was Clinicaltrials.gov: NCT01057771.

Value associated with mindfulness meditation and moderate exercise intervention in acute respiratory infection: the MEPARI Study.

BACKGROUND AND OBJECTIVES: Acute respiratory infection (ARI) is among the most common, debilitating and expensive human illnesses. The purpose of this study was to assess ARI-related costs and determine if mindfulness meditation or exercise can add value. METHODS: One hundred and fifty-four adults ≥50 years from Madison, WI for the 2009-10 cold/flu season were randomized to (i) wait-list control (ii) meditation or (iii) moderate intensity exercise. ARI-related costs were assessed through self-reported medication use, number of missed work days and medical visits. Costs per subject were based on cost of generic medications, missed work days ($126.20) and clinic visits ($78.70). Monte Carlo bootstrap methods evaluated reduced costs of ARI episodes. RESULTS: The total cost per subject for the control group was $214 (95% CI: $105-$358), exercise $136 (95% CI: $64-$232) and meditation $65 (95% CI: $34-$104). The majority of cost savings was through a reduction in missed days of work. Exercise had the highest medication costs at $16.60 compared with $5.90 for meditation (P = 0.004) and $7.20 for control (P = 0.046). Combining these cost benefits with the improved outcomes in incidence, duration and severity seen with the Meditation or Exercise for Preventing Acute Respiratory Infection study, meditation and exercise add value for ARI. Compared with control, meditation had the greatest cost benefit. This savings is offset by the cost of the intervention ($450/subject) that would negate the short-term but perhaps not long-term savings. CONCLUSIONS: Meditation and exercise add value to ARI-associated health-related costs with improved outcomes. Further research is needed to confirm results and inform policies on adding value to medical spending.

Advantage of meditation over exercise in reducing cold and flu illness is related to improved function and quality of life.

PURPOSE: To examine whether apparent advantages following training in meditation over exercise can be attributed to specific symptoms, functional impairments, or quality-of-life indicators assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-24). METHODS: Results from the randomized controlled trial "Meditation or Exercise for Preventing Acute Respiratory Illness" showed mean global severity and total days of illness were worse in control (358, 8·9) compared with exercise (248, 5·1) or meditation (144, 5·0). Global severity of illness was estimated using area under the curve from daily self-reported severity scores on the WURSS-24. For this project, we estimated within-group WURSS item-level severity and between-group effect sizes (Cohen's "d" statistic) relative to control. The item-level effect sizes were grouped into (i) symptom and (ii) function and quality of life domains. RESULTS: Among the three groups, mediators showed the lowest severity estimates for 21 of 22 WURSS items. Item-level Cohen's "d" indicated most benefit was evident in WURSS items representing function and quality of life. Compared with exercise, meditation fostered larger reductions in illness severity, although due mostly to improved function and the quality of life domain (d=-0·33, P<0·001) compared with symptom domain (d=-0·22, P<0·001). CONCLUSIONS: The apparent advantage of training in meditation over exercise for reducing cold and flu illness is explained more by improved function and quality of life than by a reduction in symptom severity.

Meditation or exercise for preventing acute respiratory infection: a randomized controlled trial.

PURPOSE: This study was designed to evaluate potential preventive effects of meditation or exercise on incidence, duration, and severity of acute respiratory infection (ARI) illness. METHODS: Community-recruited adults aged 50 years and older were randomized to 1 of 3 study groups: 8-week training in mindfulness meditation, matched 8-week training in moderate-intensity sustained exercise, or observational control. The primary outcome was area-under-the-curve global illness severity during a single cold and influenza season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) to assess severity. Health care visits and days of missed work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid. RESULTS: Of 154 adults randomized into the study, 149 completed the trial (82% female, 94% white, mean age 59.3 ± 6.6 years). There were 27 ARI episodes and 257 days of ARI illness in the meditation group (n = 51), 26 episodes and 241 illness days in the exercise group (n = 47), and 40 episodes and 453 days in the control group (n = 51). Mean global severity was 144 for meditation, 248 for exercise, and 358 for control. Compared with control, global severity was significantly lower for meditation (P = .004). Both global severity and total days of illness (duration) trended toward being lower for the exercise group (P=.16 and P=.032, respectively), as did illness duration for the meditation group (P=.034). Adjusting for covariates using zero-inflated multivariate regression models gave similar results. There were 67 ARI-related days of-work missed in the control group, 32 in the exercise group (P = .041), and 16 in the meditation group (P <.001). Health care visits did not differ significantly. Viruses were identified in 54% of samples from meditation, 42% from exercise, and 54% from control groups. Neutrophil count and interleukin-8 levels were similar among intervention groups. CONCLUSIONS: Training in meditation or exercise may be effective in reducing ARI illness burden.

Echinacea for treating the common cold: a randomized trial.

BACKGROUND: Echinacea is widely used to treat the common cold. OBJECTIVE: To assess the potential benefits of echinacea as a treatment of common cold. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00065715) SETTING: Dane County, Wisconsin. PATIENTS: 719 patients, aged 12 to 80 years, with new-onset common cold. INTERVENTION: Patients were assigned to 1 of 4 parallel groups: no pills, placebo pills (blinded), echinacea pills (blinded), or echinacea pills (unblinded, open-label). Echinacea groups received the equivalent of 10.2 g of dried echinacea root during the first 24 hours and 5.1 g during each of the next 4 days. Indistinguishable placebo tablets contained only inert ingredients. MEASUREMENTS: The primary outcome was the area under the curve for global severity, with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey, short version. Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash, assessed at intake and 2 days later. RESULTS: Of the 719 patients enrolled, 713 completed the protocol. Mean age was 33.7 years, 64% were female, and 88% were white. Mean global severity was 236 and 258 for the blinded and unblinded echinacea groups, respectively; 264 for the blinded placebo group; and 286 for the no-pill group. A comparison of the 2 blinded groups showed a 28-point trend (95% CI, -69 to 13 points) toward benefit for echinacea (P = 0.089). Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group. A comparison of the blinded groups showed a nonsignificant 0.53-day (CI, -1.25 to 0.19 days) benefit (P = 0.075). Median change in interleukin-8 levels and neutrophil counts were also not statistically significant (30 ng/L and 1 cell/high-power field [hpf] in the no-pill group, 39 ng/L and 1 cell/hpf in the blinded placebo group, 58 ng/L and 2 cells/hpf in the blinded echinacea group, and 70 ng/L and 1 cell/hpf in the open-label echinacea group). LIMITATION: Higher-than-expected variability limited power to detect small benefits. CONCLUSION: Illness duration and severity were not statistically significant with echinacea compared with placebo. These results do not support the ability of this dose of the echinacea formulation to substantively change the course of the common cold. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine, National Institutes of Health.