Investigating innovations in outpatient services: a mixed-methods rapid evaluation.

Background: Within outpatient services, a broad range of innovations are being pursued to better manage care and reduce unnecessary appointments. One of the least-studied innovations is Patient-Initiated Follow-Up, which allows patients to book appointments if and when they need them, rather than follow a standard schedule. Objectives: To use routine national hospital data to identify innovations in outpatient services implemented, in recent years, within the National Health Service in England. To carry out a rapid mixed-methods evaluation of the implementation and impact of Patient-Initiated Follow-Up. Methods: The project was carried out in four sequential workstreams: (1) a rapid scoping review of outpatient innovations; (2) the application of indicator saturation methodology for scanning national patient-level data to identify potentially successful local interventions; (3) interviews with hospitals identified in workstream 2; and (4) a rapid mixed-methods evaluation of Patient-Initiated Follow-Up. The evaluation of Patient-Initiated Follow-Up comprised an evidence review, interviews with 36 clinical and operational staff at 5 National Health Service acute trusts, a workshop with staff from 13 National Health Service acute trusts, interviews with four patients, analysis of national and local data, and development of an evaluation guide. Results: Using indicator saturation, we identified nine services with notable changes in follow-up to first attendance ratios. Of three sites interviewed, two queried the data findings and one attributed the change to a clinical assessment service. Models of Patient-Initiated Follow-Up varied widely between hospital and clinical specialty, with a significant degree of variation in the approach to patient selection, patient monitoring and discharge. The success of implementation was dependent on several factors, for example, clinical condition, staff capacity and information technology systems. From the analysis of national data, we found evidence of an association between greater use of Patient-Initiated Follow-Up and a lower frequency of outpatient attendance within 15 out of 29 specialties and higher frequency of outpatient attendance within 7 specialties. Four specialties had less frequent emergency department visits associated with increasing Patient-Initiated Follow-Up rates. Patient-Initiated Follow-Up was viewed by staff and the few patients we interviewed as a positive intervention, although there was varied impact on individual staff roles and workload. It is important that sites and services undertake their own evaluations of Patient-Initiated Follow-Up. To this end we have developed an evaluation guide to support trusts with data collection and methods. Limitations: The Patient-Initiated Follow-Up evaluation was affected by a lack of patient-level data showing who is on a Patient-Initiated Follow-Up pathway. Engagement with local services was also challenging, given the pressures facing sites and staff. Patient recruitment was low, which affected the ability to understand experiences of patients directly. Conclusions: The study provides useful insights into the evolving national outpatient transformation policy and for local practice. Patient-Initiated Follow-Up is often perceived as a positive intervention for staff and patients, but the impact on individual outcomes, health inequalities, wider patient experience, workload and capacity is still uncertain. Future research: Further research should include patient-level analysis to determine clinical outcomes for individual patients on Patient-Initiated Follow-Up and health inequalities, and more extensive investigation of patient experiences. Study registration: This study is registered with the Research Registry (UIN: researchregistry8864). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 16/138/17) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 38. See the NIHR Funding and Awards website for further award information.

When someone visits hospital for an operation or an ongoing condition, they are given follow-up appointments at clinics, often after 6 months. The National Health Service thinks that many of these appointments are not necessary because they are not useful to patients. Also, outside fixed appointments, patients are not always being seen when they are most in need. Hospitals have been testing new ways to improve services. We looked at hospital data and discussed interesting findings with hospitals themselves to see if we could find approaches that worked. We then looked at one new approach called Patient-Initiated Follow-Up. Patients using Patient-Initiated Follow-Up can book appointments when they are needed, rather than at a pre-planned time. We explored how Patient-Initiated Follow-Up was being used in hospitals, what effect it was having and what patients and National Health Service staff thought about it. We studied hospital data and interviewed patients and National Health Service staff. We found that Patient-Initiated Follow-Up works differently depending on the hospital and the patient's condition. Patient-Initiated Follow-Up is most frequently used for patients needing short-term follow-up, such as after an operation. It is also starting to be used for patients with long-term chronic conditions. National Health Service staff think that Patient-Initiated Follow-Up can benefit patients, although some may find it easier to use than others. Patients appear to like Patient-Initiated Follow-Up, but some still prefer to let the hospital schedule appointments. From data it appears that for some conditions, where more patients use Patient-Initiated Follow-Up, fewer follow-up visits are required. For a few conditions, there is evidence of fewer emergency department visits, but the overall impact is small. We interviewed staff from a small number of hospitals and four patients, so what we found may not apply across the National Health Service. We also developed a guide to help hospitals evaluate the success of their own Patient-Initiated Follow-Up services.

OMX: A NOVEL OXYGEN DELIVERY BIOTHERAPEUTIC IMPROVES OUTCOMES IN AN OVINE MODEL OF CONTROLLED HEMORRHAGIC SHOCK.

ABSTRACT: Hemorrhagic shock is a major source of morbidity and mortality worldwide. While whole blood or blood product transfusion is a first-line treatment, maintaining robust supplies presents significant logistical challenges, particularly in austere environments. OMX is a novel nonhemoglobin (Hb)-based oxygen carrier derived from the H-NOX (heme-nitric oxide/oxygen binding) protein family. Because of their engineered oxygen (O 2 ) affinities, OMX proteins only deliver O 2 to severely hypoxic tissues. Additionally, unlike Hb-based oxygen carriers, OMX proteins do not scavenge nitric oxide in the vasculature. To determine the safety and efficacy of OMX in supporting tissue oxygen delivery and cardiovascular function in a large animal model of controlled hemorrhage, 2-3-week-old lambs were anesthetized, intubated, and mechanically ventilated. Hypovolemic shock was induced by acute hemorrhage to obtain a 50% reduction over 30 min. Vehicle (n = 16) or 400 mg/kg OMX (n = 13) treatment was administered over 15 min. Hemodynamics, arterial blood gases, and laboratory values were monitored throughout the 6-h study. Comparisons between groups were made using t tests, Wilcoxon rank sum test, and Fisher's exact test. Survival was assessed using Kaplan-Meier curves and the log-rank test. We found that OMX was well-tolerated and significantly improved lactate and base deficit trends, and hemodynamic indices ( P < 0.05). Median survival time was greater in the OMX-treated group (4.7 vs. 6.0 h, P < 0.003), and overall survival was significantly increased in the OMX-treated group (25% vs. 85%, P = 0.004). We conclude that OMX is well-tolerated and improves metabolic, hemodynamic, and survival outcomes in an ovine model of controlled hemorrhagic shock.

Effect of Clemastine on Neurophysiological Outcomes in an Ovine Model of Neonatal Hypoxic-Ischemic Encephalopathy.

Originally approved by the U.S. Food and Drug Administration (FDA) for its antihistamine properties, clemastine can also promote white matter integrity and has shown promise in the treatment of demyelinating diseases such as multiple sclerosis. Here, we conducted an in-depth analysis of the feasibility, safety, and neuroprotective efficacy of clemastine administration in near-term lambs (n = 25, 141-143 days) following a global ischemic insult induced via an umbilical cord occlusion (UCO) model. Lambs were randomly assigned to receive clemastine or placebo postnatally, and outcomes were assessed over a six-day period. Clemastine administration was well tolerated. While treated lambs demonstrated improvements in inflammatory scores, their neurodevelopmental outcomes were unchanged.

Perinatal Azithromycin Provides Limited Neuroprotection in an Ovine Model of Neonatal Hypoxic-Ischemic Encephalopathy.

BACKGROUND: Hypoxic-ischemic brain injury/encephalopathy affects about 1.15 million neonates per year, 96% of whom are born in low- and middle-income countries. Therapeutic hypothermia is not effective in this setting, possibly because injury occurs significantly before birth. Here, we studied the pharmacokinetics, safety, and efficacy of perinatal azithromycin administration in near-term lambs following global ischemic injury to support earlier treatment approaches. METHODS: Ewes and their lambs of both sexes (n=34, 141-143 days) were randomly assigned to receive azithromycin or placebo before delivery as well as postnatally. Lambs were subjected to severe global hypoxia-ischemia utilizing an acute umbilical cord occlusion model. Outcomes were assessed over a 6-day period. RESULTS: While maternal azithromycin exhibited relatively low placental transfer, azithromycin-treated lambs recovered spontaneous circulation faster following the initiation of cardiopulmonary resuscitation and were extubated sooner. Additionally, peri- and postnatal azithromycin administration was well tolerated, demonstrating a 77-hour plasma elimination half-life, as well as significant accumulation in the brain and other tissues. Azithromycin administration resulted in a systemic immunomodulatory effect, demonstrated by reductions in proinflammatory IL-6 (interleukin-6) levels. Treated lambs exhibited a trend toward improved neurodevelopmental outcomes while histological analysis revealed that azithromycin supported white matter preservation and attenuated inflammation in the cingulate and parasagittal cortex. CONCLUSIONS: Perinatal azithromycin administration enhances neonatal resuscitation, attenuates neuroinflammation, and supports limited improvement of select histological outcomes in an ovine model of hypoxic-ischemic brain injury/encephalopathy.

Defining Longer-Term Outcomes in an Ovine Model of Moderate Perinatal Hypoxia-Ischemia.

Hypoxic-ischemic encephalopathy (HIE) is the leading cause of neonatal morbidity and mortality worldwide. Approximately 1 million infants born with HIE each year survive with cerebral palsy and/or serious cognitive disabilities. While infants born with mild and severe HIE frequently result in predictable outcomes, infants born with moderate HIE exhibit variable outcomes that are highly unpredictable. Here, we describe an umbilical cord occlusion (UCO) model of moderate HIE with a 6-day follow-up. Near-term lambs (n = 27) were resuscitated after the induction of 5 min of asystole. Following recovery, lambs were assessed to define neurodevelopmental outcomes. At the end of this period, lambs were euthanized, and brains were harvested for histological analysis. Compared with prior models that typically follow lambs for 3 days, the observation of neurobehavioral outcomes for 6 days enabled identification of animals that recover significant neurological function. Approximately 35% of lambs exhibited severe motor deficits throughout the entirety of the 6-day course and, in the most severely affected lambs, developed spastic diparesis similar to that observed in infants who survive severe neonatal HIE (severe, UCOs). Importantly, and similar to outcomes in human neonates, while initially developing significant acidosis and encephalopathy, the remainder of the lambs in this model recovered normal motor activity and exhibited normal neurodevelopmental outcomes by 6 days of life (improved, UCOi). The UCOs group exhibited gliosis and inflammation in both white and gray matters, oligodendrocyte loss, neuronal loss, and cellular death in the hippocampus and cingulate cortex. While the UCOi group exhibited more cellular death and gliosis in the parasagittal cortex, they demonstrated more preserved white matter markers, along with reduced markers of inflammation and lower cellular death and neuronal loss in Ca3 of the hippocampus compared with UCOs lambs. Our large animal model of moderate HIE with prolonged follow-up will help further define pathophysiologic drivers of brain injury while enabling identification of predictive biomarkers that correlate with disease outcomes and ultimately help support development of therapeutic approaches to this challenging clinical scenario.