[Posted 27/Feb/2024]

AUDIENCE: Nursing

KEY FINDINGS: FIC improved the optimal target oxygen saturation ratio before discharge and shortened the duration of HOT in premature infants with moderate and severe BPD. FIC should be promoted in China's neonatal intensive care units, though it puts forward new requirements for nursing education and training.

BACKGROUND: There have been few reports on whether family integrated care (FIC) can help premature infants with moderate to severe bronchopulmonary dysplasia (BPD) to shorten the duration of home oxygen therapy (HOT). Objective of this study is to investigate the effect of FIC on the duration of HOT in premature infants with moderate to severe BPD.

DETAILS: The subjects were retrospectively selected from premature infants with moderate to severe BPD in authors' center between June 2019 and December 2021. Patients were divided into the FIC group (n = 47) and the non-FIC group (n = 34). For univariate analysis, t test, Mann–Whitney U test, Pearson χ² test, or Fisher exact test was performed to explore the differences between the 2 groups. For multivariate analysis, simple and multiple linear regression was conducted to explore the effect of FIC on the duration of HOT. (1) The duration of HOT and length of stay after grouping were significantly shorter in the FIC group than in the non-FIC group (P < .05). (2) The results of linear regression further revealed that FIC could significantly shorten the duration of HOT (simple linear regression, FIC [A] B: -12.709, 95% confidence interval (CI): -21.665 to -3.753; multiple linear regress

Copyright © The National Association of Neonatal Nurses. All rights reserved.

Source: Shen, F., Wu, X., Chen, X., et al. (2024). Family Integrated Care Shortens the Duration of Home Oxygen Therapy in Infants With Bronchopulmonary Dysplasia. Advances in Neonatal Care. 2024; 24(1): 27-34. Published: February, 2024. DOI: 10.1097/ANC.0000000000001119.

[Posted 31/Dec/2024]

AUDIENCE: Nursing

KEY FINDINGS: Nursing staff interventions regarding shock team activation significantly improved the time of diagnosis and acceptance of patients with cardiogenic shock in a cardiovascular hospital, enhancing the overall quality of care provided to these patients.

BACKGROUND: Patients with cardiogenic shock have a 25% to 50% mortality rate despite the introduction of mechanical circulatory devices and coordinated medical treatment. The use of shock teams has improved outcomes for these patients.

DETAILS: A cardiovascular hospital with a multidisciplinary shock team had inconsistency and delays in recognition and diagnosis of patients with cardiogenic shock. A nurse-led, preintervention-postintervention quality improvement project was performed in April and May 2021 and in April and May 2022 within a cardiovascular hospital in north Texas. The 2 nursing staff interventions regarding shock team activation were education and shock alert implementation. Time from first signs to diagnosis (for inpatients) and time from initial transfer request to acceptance (for transferring patients) were measured. Descriptive and statistical analyses were conducted using R, version 4.0.0 (R Foundation for Statistical Computing). The mean (SD) time to diagnosis of cardiogenic shock decreased significantly from 17.98 (28.39) hours in the preintervention group (n = 25) to 8.15 (12.26) hours in the postintervention group (n = 45; P = .045). For patients with cardiogenic shock transferring from referring hospitals, the median (IQR) time to acceptance was 1.55 (0.08-3.18) hours in the preintervention group and 0.35 (0.00-0.72) hours in the postintervention group (P < .001).

Copyright © American Association of Critical-Care Nurses. All rights reserved.

Source: Krais, S., Sheasby, J., Banwait, J., et al. (2024). Improving Cardiogenic Shock Team Activation Through Nurse Education and Alert Implementation. Crit Care Nurse. 2024; 44(6): 24–30. Published: October, 2024. DOI: 10.4037/ccn2024259.

The YAWNS NB Randomized Clinical Trial

[Posted 30/Dec/2024]

AUDIENCE: Psychiatry, Family Medicine

KEY FINDINGS: Results of the YAWNS NB randomized clinical trial show that, as a simple, scalable, direct-to-patient intervention, YAWNS-1 substantially reduced BZRA use and improved sleep outcomes. It could be implemented to transform insomnia care for older adults at the population level.

BACKGROUND: Direct-to-patient interventions enabling transitions from long-term benzodiazepine receptor agonist (BZRA) use to cognitive behavioral therapy for insomnia (CBTI) by older adults has the potential to reduce BZRA use and related harms while improving sleep outcomes without requiring prearranged clinician involvement. Aim of this study was to compare 2 direct-to-patient behavior change interventions with treatment as usual (TAU) on BZRA use, sleep, and other health outcomes, and uptake of CBTI techniques.

DETAILS: The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study was a 3-arm, pragmatic, open-label, minimum-contact, randomized clinical trial. The study began November 2020 and ended June 2022. Participants were randomly allocated to 1 of 3 groups, including 2 different mailed behavior change interventions or no intervention (TAU). Participants were from communities across the province of New Brunswick, Canada, and included adults 65 years and older living independently with long-term use of BZRAs and current or past insomnia. The Sleepwell package (YAWNS-1) consisted of a cover letter and 2 booklets (“How to Stop Sleeping Pills” and “How to Get Your Sleep Back”). The other package (YAWNS-2) included updated versions of the 2 booklets (“You May Be at Risk” and “How to Get a Good Night’s Sleep Without Medication”) used in the Eliminating Medications Through Patient Ownership of End Results (EMPOWER) study. Main outcomes and measures: BZRA use at 6 months was the primary measure. Secondary measures included CBTI use, sleep, insomnia, daytime sleepiness, safety, anxiety, frailty, and quality of life.

A total of 1295 individuals expressed interest in the study, and 565 (43.6%) completed a baseline assessment. Participants had a mean (SD) age of 72.1 (5.7) years, a mean (SD) BZRA use duration of 11.4 (9.1) years, and 362 (64.1%) were female. Discontinuations and dose reductions of 25% or greater were highest with YAWNS-1 (50 of 191 [26.2%]; 39 of 191 [20.4%]; total, 46.6%) compared with YAWNS-2 (38 of 187 [20.3%]; 27 of 187 [14.4%]; total, 34.8%, P = .02) and TAU (14 of 187 [7.5%]; 24 of 187 [12.8%]; total, 20.3%, P < .001). YAWNS-1 also demonstrated better uptake of CBTI techniques and sleep outcomes compared with YAWNS-2 (new CBTI techniques: 3.1 vs 2.4; P =.03; sleep efficiency change: 4.1% vs -1.7%; P =.001) and reduced insomnia severity and daytime sleepiness compared with TAU (insomnia severity index change: -2.0 vs 0.3; P <.001; Epworth Sleepiness Scale change: -0.8 vs 0.3; P =.001).

Copyright © American Medical Association. All Rights Reserved.

Source: Gardner, D. M., Turner, J. P., Magalhaes, S., et al. (2024). Patient Self-Guided Interventions to Reduce Sedative Use and Improve Sleep: The YAWNS NB Randomized Clinical Trial. JAMA Psychiatry. 2024; 81(12): 1187-1197. Published: December, 2024. DOI: 10.1001/jamapsychiatry.2024.2731.

[Posted 26/Nov/2024]

AUDIENCE: Cardiology, Emergency Medicine

ACTION: The U.S. Food and Drug Administration has approved Attruby (acoramidis) to treat adults with cardiomyopathy (disorder that affects heart muscle) of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems.

Attruby is taken orally, twice daily. Recommended dosing is available in the prescribing information.

DISEASE OR CONDITION: ATTR-CM is a rare and serious disease that affects the heart muscle. In patients with ATTR-CM, there is a build-up of protein deposits in the heart, causing the walls of the heart to become stiff, and making the left ventricle unable to properly relax and fill with blood (called cardiomyopathy). As the condition progresses, the heart can become unable to pump blood out adequately, causing heart failure.

There are two types of ATTR-CM, hereditary ATTR-CM (hATTR-CM) and wild-type ATTR-CM (wATTR-CM). In hATTR-CM, which can run in families, there’s a variant in the transthyretin gene, which results in protein deposits in the heart. In wATTR-CM, there is no variant in the transthyretin gene.

While the true prevalence of ATTR-CM is unknown, increasing awareness and enhanced diagnostic tools have led to increasing estimates of the number of patients with ATTR-CM.

EFFECTIVENESS: The efficacy and safety of Attruby were evaluated in a multicenter, international, randomized, double-blind, placebo-controlled study in 611 adult patients with wild-type or hereditary (variant) ATTR-CM (NCT03860935).

The primary endpoint of the study included all-cause mortality and cumulative frequency of cardiovascular-related hospitalizations (CVH) over 30 months. At 30 months, more patients taking Attruby vs placebo were alive (81% vs 74%) and there were fewer CVH in those taking Attruby vs placebo (mean number of 0.3 vs 0.6 per year).

SAFETY INFORMATION: The most common adverse reactions were diarrhea and upper abdominal pain. Most of these gastrointestinal adverse reactions were categorized as mild and resolved without drug discontinuation.

DESIGNATIONS: Attruby received orphan drug designation for this indication.

Source: FDA Approves Drug for Heart Disorder Caused by Transthyretin-Mediated Amyloidosis. FDA. Published: November 25, 2024.

[Posted 4/Nov/2024]

AUDIENCE: Nursing, Ob/Gyn

KEY FINDINGS: The interventions significantly reduced the number of neonates admitted to the ICU with hypothermia. Implementation of thermoregulation bundles should apply to all neonates with congenital anomalies to decrease risks associated with hypothermia.

BACKGROUND: Thermoregulation interventions in the delivery room have historically focused on preterm infants and studies often exclude term infants or those infants with known congenital anomalies. The purpose of this quality improvement project was to reduce the rate of admission hypothermia in neonates of all gestational ages born with congenital anomalies and admitted to the intensive care unit (ICU).

DETAILS: Utilizing the Institute for Healthcare Improvement model for improvement, implementation of plan, do study, act cycles focused on standardizing temperatures of the delivery room and resuscitation bed, recommendations for temperature monitoring, trialing polyethylene lined hats, and implementing a delivery room thermoregulation checklist. Overall, the mean rate of neonates admitted to the ICU hypothermic (36.5°C) decreased from 27% to 9% over an 8-month period.

Copyright © The National Association of Neonatal Nurses. All rights reserved.

Source: Heimall, L., Barrila-Yetman, M., McCray, K., et al. (2024). Preventing Hypothermia in Newborns With Congenital Anomalies in the Delivery Room. Advances in Neonatal Care . 2024; 24(5): 408-416. Published: October, 2024. DOI: 10.1097/ANC.0000000000001184.

[Posted 17/Oct/2024]

AUDIENCE: Emergency Medicine

KEY FINDINGS:

BACKGROUND: Over several days in late September 2024, Hurricane Helene caused extensive damage to the southeastern United States. The storm affected the Baxter International's North Cove facility in North Carolina, the largest manufacturer of peritoneal dialysis and intravenous solutions in the United States, halting production.

DETAILS: CDC is issuing this Health Alert Network (HAN) Health Advisory to inform healthcare providers, pharmacists, healthcare facility administrators, and state, tribal, local, and territorial health departments of a supply disruption of peritoneal dialysis (PD) and intravenous (IV) solutions from the Baxter International's North Cove facility in North Carolina, due to Hurricane Helene.

The supply disruption may impact patient care and require adjustments to the clinical management of patients. Healthcare providers, pharmacists, healthcare facility administrators, and state, tribal, local, and territorial health departments, regardless of supply chain disruptions, should immediately assess their supply and develop plans and mitigation strategies to reduce the impact on patient care.

This Health Advisory summarizes recommendations from the Food and Drug Administration (FDA); the Administration for Strategic Preparedness and Response Technical Resources, Assistance Center, and Information Exchange (ASPR TRACIE) ; the American Society of Health-System Pharmacists (ASHP); the American Society of Nephrology (ASN); and the American Society of Pediatric Nephrology (ASPN) among others, to address supply disruptions of PD and IV solutions.

Facilities can implement strategies early to conserve their fluid supplies and avoid waste to reduce the impact on services. Strategies must ensure patient safety, timely and effective safety notifications, and education of healthcare personnel and patients. Emergency medical and outpatient services must be included in these strategies.

Additional supply disruption may occur in the aftermath of Hurricane Milton.

Recommendations

Healthcare Providers, Pharmacists, and Healthcare Facility Administrators in Healthcare Facilities

• Assess inventory, supply, and conserve available IV solutions.
• Determine the type of IV solutions your pharmacy or facility uses, including expiration dates, and whether this supply disruption will impact your facility.
• Monitor current and future supplies of IV solutions at your facility.
• Report any potential shortages or interruptions to the Food and Drug Administration (FDA) at DrugShortages@fda.hhs.gov.
• Implement a facility-specific action plan to optimize the use of IV solutions using evidence-based fluid management protocols.
• Evaluate all protocols, including the clinical need to continue IV fluid replacement at every shift change, bag change, and during the transition of care unless clinically necessary.
• Ensure that advisory committees with appropriate authorities are established to determine complex issues in supply disruptions and allocation of limited resources and patient triage as needed.
• Use oral formulations when IV options are not available and when appropriate and safe.
• Identify safe and effective alternative IV options (e.g., working with a nearby facility or licensed manufacturer who is not affected by the supply disruption).
• Review standing orders, including drug records and order sets.
• Ensure thorough documentation of the situation, including consumption of IV solutions.
• See FDA's Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International's North Cove facility.
• Ensure multidisciplinary team involvement to determine and develop conservation and stewardship strategies using IV solutions in specific patient populations.
• Include providers from various expertise (including key outpatient settings such as emergency departments, hematology/oncology, ambulatory surgery centers, wound care centers, infusion centers, home healthcare, etc.), pharmacists, nurses, infection control, informatics, patient safety, supply chain leadership, and emergency preparedness.
• Provide education and training to healthcare providers regarding any changes in protocols.
• Communicate changes in current practice, disruption, new shortages, and action plan adjustments to hospital leadership and frontline staff.
• Communicate with patients to assess supplies and provide a mechanism to notify their providers of insufficient supplies.

Providers and Administrators in Dialysis Facilities

• Assess and monitor inventory of available PD solutions.
• Review current practices to identify changes that extend the PD solution supply safely.
• Monitor current and future supplies of PD solutions.
• Report any interruptions to the FDA at DrugShortages@fda.hhs.gov.

• Implement an action plan for emergency PD treatment protocols
• Assess emergency PD protocols.
• Ensure optimal PD catheter function and flow of all patients to maximize ultrafiltration and solute exchange (malposition, etc.).
• Optimize prescriptions; overall approaches should prioritize bag-sparing rather than solution-sparing.
• For example, consider changing dwell times rather than adding a PD solution bag if a prescription change is needed for a patient.
• Monitor patients closely after prescription adjustments, including phone check-ins.
• Communicate with patients receiving peritoneal dialysis at home and their care providers.
• Assess supplies and provide a mechanism to notify their provider of insufficient supplies.
• Provide education and training to patients and their care providers regarding any changes in PD bags or associated products (e.g., adaptors, tubing, etc.) used for their treatments.
• Consider options for individual patients, keeping safety in mind.
• Continuous ambulatory PD (CAPD) may be a good option for some patients.
• Transitioning to hemodialysis (HD) should be avoided as much as possible. However, if adjustment of PD prescription has been explored and exhausted, a temporary transition to HD may be necessary if the available supply is insufficient to provide adequate PD.
• Reinforce patient safety principles when not using usual products and procedures to prevent patient injury and medical errors.

State, Tribal, Local, and Territorial Health Departments

• Maintain situational awareness of the severity of the supply disruption and implement strategies.
• Where possible, facilitate communication across health systems within the jurisdictions related to acute supply needs.

Source: CDC Issues Health Alert In Light of Disruptions in Availability of PD and IV Solutions from Baxter International Facility in North Carolina. CDC. 2024; Published: October, 2024.