A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study): Study protocol.

BACKGROUND: In real-world settings, low adherence to lung cancer screening (LCS) diminishes population-level benefits of reducing lung cancer mortality. We describe the Larch Study protocol, which tests the effectiveness of two patient-centered interventions (Patient Voices Video and Stepped Reminders) designed to address barriers and improve annual LCS adherence. METHODS: The Larch Study is a pragmatic randomized clinical trial conducted within Kaiser Permanente Washington. Eligible patients (target n = 1606) are aged 50-78 years with an index low-dose CT (LDCT) of the chest with negative or benign findings. With a 2 × 2 factorial-design, patients are individually randomized to 1 of 4 arms: video only, reminders only, both video and reminders, or usual care. The Patient Voices video addresses patient education needs by normalizing LCS, reminding patients when LCS is due, and encouraging social support. Stepped Reminders prompts primary care physicians to order patient's repeat screening LDCT and patients to schedule their scan. Intervention delivery is embedded within routine healthcare, facilitated by shared electronic health record components. Primary outcome is adherence to national LCS clinical guidelines, defined as repeat LDCT within 9-15 months. Patient-reported outcomes are measured via survey (knowledge of LCS, perception of stigma) approximately 8 weeks after index LDCT. Our mixed-methods formative evaluation includes process data, collected during the trial, and interviews with trial participants and stakeholders. DISCUSSION: Results will fill an important scientific gap on multilevel interventions to increase annual LCS adherence and provide opportunities for spread and scale to other healthcare settings. REGISTRATION: Trial is registered at clinicaltrials.gov (#NCT05747443).

Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial.

BACKGROUND: Severe hypoglycemia is a common and feared complication of medications used to lower blood glucose levels in individuals with diabetes. Psychoeducational interventions can prevent severe hypoglycemia in individuals with type 1 diabetes (T1D). We aim to determine the effectiveness of this approach among adults with type 2 diabetes (T2D) at elevated risk for severe hypoglycemia. METHODS: Preventing Hypoglycemia in Type 2 diabetes (PHT2) is a two-arm, parallel, randomized controlled trial. Participants are eligible if they are adults with T2D receiving care at an integrated group practice in Washington state and have experienced one or more episodes of severe hypoglycemia in the prior 12 months or have impaired awareness of hypoglycemia (Gold score ≥ 4). Participants are randomized to proactive nurse care management with or without my hypo compass, an evidence-based, psychoeducational intervention combining group and individual self-management training. For this study, my hypo compass was adapted to be suitable for adults with T2D and from an in-person to a virtual intervention over videoconference and telephone. The primary outcome is any self-reported severe hypoglycemia in the 12 months following the start of the intervention. Secondary outcomes include biochemical measures of hypoglycemia, self-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. The study includes a process evaluation to assess implementation fidelity and clarify the causal pathway. CONCLUSION: The PHT2 trial will compare the effectiveness of two approaches for reducing severe hypoglycemia in adults with T2D. TRIAL REGISTRATION: clinicaltrials.gov, # NCT04863872.

Reducing Device-Related Pressure Injuries Associated With Noninvasive Ventilation in the Neonatal Intensive Care Unit.

BACKGROUND: Noninvasive ventilation (NIV) has become the preferable modality of respiratory support for spontaneously breathing premature infants in the neonatal ICU (NICU). Whereas NIV support contributes to the prevention of long-term respiratory sequelae from mechanical ventilation, the nasal interfaces used are well known for placing patients at risk for development of NIV device-related pressure injuries (PIs). After implementing clinical practice guidelines promoting the use of sealing NIV interfaces for respiratory support in a level IV NICU, an increase in the frequency of stage 2 or worse and deep tissue injury (DTI) PI was observed. We hypothesized that the implementation of a multifaceted skin care bundle (SCB) would reduce the incidence of NIV device-related PI. METHODS: Quality improvement methodology was used to evaluate the impact of implementing an SCB for patients supported with NIV via a nasal interface. Incidence rate of stage 2 or worse and DTI PI was reported per 100 NIV days over 4 distinct time periods: (1) pre-NIV guideline, (2) post-NIV guideline, (3) post SCB, and (4) sustainability phase. Incidence comparisons were made using one-sided P values from the Farrington-Manning test of equal risks with a significance level of 0.05. RESULTS: The NICU experienced a notable rise in NIV device-related PI after implementation of NIV guidelines (0.01 vs 0.34 per 100 NIV days; P = .01). After application of an SCB, a decrease in NIV device-related skin PI was achieved (0.34 vs 0.07 per 100 NIV days; P = .04), representing a 79% reduction. CONCLUSIONS: A collaborative and multidisciplinary team approach was used to promote engagement with clinical staff to address a preventable harm. The implementation of a multifaceted PI prevention bundle contributed to reducing harm while permitting the continued use of appropriate respiratory support to a highly vulnerable patient population in the NICU.

Enhanced fluid management with continuous venovenous hemofiltration in pediatric respiratory failure patients receiving extracorporeal membrane oxygenation support.

BACKGROUND/PURPOSE: Children receiving extracorporeal membrane oxygenation (ECMO) for respiratory failure can have significant fluid overload and renal insufficiency. Addition of inline continuous venovenous hemofiltration (CVVH) could provide additional benefits in fluid management compared to use of standard medical therapies with ECMO. METHODS: Patients with pediatric respiratory failure receiving ECMO with CVVH were case-matched to similar patients receiving ECMO without CVVH to compare fluid balance, medication use, and clinical outcomes. RESULTS: Twenty-six of eighty-six patients with pediatric respiratory failure on ECMO (30%) received CVVH for >24 h (median 7.5 days on CVVH). Survival was not significantly different between patients receiving CVVH and those who did not receive CVVH (P = 0.51). For ECMO survivors receiving CVVH, overall fluid balance was less than that in non-CVVH survivors (median 25.1 ml kg(-1) day(-1); range -40.2 to 71.2 vs. 40.2, 1.1 to 134.9; P = 0.028). Time to desired caloric intake was faster in patients receiving CVVH (1 day, 1-5) than in patients who did not receive CVVH (5 days; 1-11; P < 0.001). Patients receiving CVVH-ECMO also received less furosemide (0.67 vs. 2.11 mg kg(-1) day(-1); P = 0.009). CONCLUSIONS: Use of CVVH in ECMO was associated with improved fluid balance and caloric intake and less diuretics than in case-matched ECMO controls.

Use of methylene blue spectrophotometry to detect subclinical aspiration in enterally fed intubated pediatric patients.

OBJECTIVE: Enteral feeding is widely used in ventilated patients admitted to pediatric intensive care units. Although studies in adult patients have shown that the site of feeding (stomach vs. small intestine) may be associated with aspiration pneumonia, there are no such reports in critically ill pediatric patients. We hypothesized that in intubated pediatric patients, there was no difference in the frequency of aspiration between nasogastric and postpyloric enteral feeding. DESIGN: Randomized, prospective clinical study. SETTING: Single pediatric intensive care unit of a tertiary care children's hospital. PATIENTS: Forty-four intubated patients (< or = 18 yrs old). INTERVENTIONS: Intubated patients were randomized to receive either nasogastric (n = 27) or postpyloric (n = 17) enteral feeding. Feeding tube placement by the bedside nurse was confirmed by abdominal radiograph. Methylene blue was added at a standard dilution to an age-appropriate formula. Tracheal secretions were suctioned every 8 hrs, tested for blue color by observation, and analyzed via spectrophotometry. Patients were followed until feeds were stopped for anticipated extubation. Aspiration pneumonia was defined using criteria of the Centers of Disease Control and Prevention (CDC). MEASUREMENTS AND MAIN RESULTS: Methylene blue was detected in two patients in the postpyloric group by spectrophotometry. None of the patients met the CDC criteria for aspiration. There was no difference in the frequency of aspiration between the two groups (p < .07). The time until beginning feedings in the postpyloric group was greater than that for the nasogastric group (18-24 hrs vs. 6 hrs, p < .05). The postpyloric group required more abdominal radiographs compared with the nasogastric group (three radiographs vs. one, p < .05). CONCLUSIONS: Use of nasogastric feeding shortens the time needed to reach nutritional goals and reduces the number of radiographic studies. Nasogastric feeding demonstrates no increase in aspiration compared with postpyloric feeding in intubated pediatric patients.

Comparison of temporal artery thermometer to standard temperature measurements in pediatric intensive care unit patients.

OBJECTIVES: To determine the accuracy of noninvasive infrared temporal artery thermometry compared with rectal, axillary, and pulmonary artery catheter measurements in pediatric intensive care patients, and to determine whether temporal artery temperatures are affected by circulatory shock or by vasopressor use. We hypothesized that temporal artery temperatures do not differ from axillary and rectal temperatures in critically ill children, but temporal artery accuracy is decreased by shock or vasopressor use. DESIGN: Observational study, unblinded. SETTING: Pediatric intensive care unit of a quarternary referral children's hospital. PATIENTS: Seventy-five temperature comparison pairs were obtained in 44 pediatric intensive care unit patients. INTERVENTIONS: Temperature measurements were made using a temporal artery thermometer with simultaneously obtained rectal, axillary, and, when available, pulmonary artery catheter measurements. MEASUREMENTS AND MAIN RESULTS: Mean bias was calculated between comparison pairs using each temperature method. Bland-Altman analysis demonstrated wide variability between methods. No significant differences in mean bias were seen between method pairs for all temperatures, but bias was significantly less in pulmonary artery catheter-rectal pairs compared with other method pairs. In febrile (> 38 degrees C) patients, bias in rectal-temporal artery and rectal-axillary was significantly greater than in temporal artery-axillary pairs (p < .001). Mean bias in pulmonary artery catheter-rectal pairs was also significantly smaller than in other pairs for all patients (p = .008) and febrile patients (p = .049). Presence of shock or vasopressor use did not significantly increase bias in any comparison pair. Sensitivity and specificity of both temporal artery and axillary for diagnosing fever were similar and improved with fever definition at temperatures > 38.5 degrees C. CONCLUSIONS: Temporal artery and axillary temperature measurements showed variability to rectal temperatures but had marked variability in febrile children. Neither was sufficiently accurate to recommend replacing rectal or other invasive methods. As temporal artery and axillary provide similar accuracy, temporal artery thermometers may serve as a suitable alternative for patients in whom invasive thermometry is contraindicated.

Multi-centre evaluation of anticoagulation in patients receiving continuous renal replacement therapy (CRRT).

BACKGROUND: Heparin (hepACG) and regional citrate anticoagulation (citACG) remain the most commonly reported continuous renal replacement therapy (CRRT) ACG methods employed. No prospective multi-centre published data exist that compare different ACG methods with respect to CRRT filter life span or patient complications. METHODS: A total of 138 patients from seven US centres receiving 18 208 h of CRRT comprising a total of 442 CRRT circuits were utilized to assess filter life span and ACG-related complications in patients receiving CRRT with hepACG, citACG or no ACG (noACG). RESULTS: Mean circuit life was 41.2+/-30.8 h. Mean circuit survival was no different for circuits receiving hepACG (42.1+/-27.1 h) and citACG (44.7+/-35.9 h), but was significantly lower for circuits with noACG (27.2+/-21.5 h, P<0.005). Kaplan-Meier analyses revealed no survival difference between hepACG and citACG circuits, but significantly lower survival for noACG circuits (P<0.001). Log-rank analysis showed that 69% of hepACG and citACG circuits whereas only 28% of noACG were functional at 60 h. Clotting rates were similar for hepACG circuits (58 out of 230, 25%) and citACG circuits (43 out of 158, 27%), but were significantly higher for noACG circuits (27 out of 54, 50%, P < 0.001). Life-threatening bleeding complications attributable to ACG were noted in the hepACG group but were absent in the citACG group. CONCLUSIONS: The current analysis represents the largest evaluation of CRRT ACG methods to date. While the standard hepACG and citACG methods studied in the prospective paediatric CRRT registry led to similar filter life spans and were superior to noACG, our data suggest that citACG may result in less life-threatening complications.

Pediatric patients with multi-organ dysfunction syndrome receiving continuous renal replacement therapy.

BACKGROUND: Critical illness leading to multi-organ dysfunction syndrome (MODS) and associated acute renal failure (ARF) is less common in children compared to adult patients. As a result, many issues plague the pediatric ARF outcome literature, including a relative lack of prospective study, a lack of modality stratification in subject populations and inconsistent controls for patient illness severity in outcome analysis. METHODS: We now report data from the first multicenter study to assess the outcome of pediatric patients with MODS receiving continuous renal replacement therapy (CRRT). One hundred twenty of 157 Registry patients (63 male/57 female) experienced MODS during their course. RESULTS: One hundred sixteen patients had complete data available for analysis. The most common causes leading to CRRT were sepsis (N= 47; 39.2%) and cardiogenic shock (N= 24; 20%). Overall survival was 51.7%. Pediatric Risk of Mortality (PRISM 2) score, central venous pressure (CVP), and% fluid overload (%FO) at CRRT initiation were significantly lower for survivors versus nonsurvivors. Multivariate analysis controlling for severity of illness using PRISM 2 at CRRT initiation revealed that%FO was still significantly lower for survivors versus nonsurvivors (P < 0.05) even for patients receiving both mechanical ventilation and vasoactive pressors. We speculate that increased fluid administration from PICU admission to CRRT initiation is an independent risk factor for mortality in pediatric patients with MODS receiving CRRT. CONCLUSION: We suggest that after initial resuscitative efforts, an increased emphasis should be placed on early initiation of CRRT and inotropic agent use over fluid administration to maintain acceptable blood pressure.