Designing a Website to Support a Multisite, International Clinical Trial.

BACKGROUND: Safe and reliable implementation of complex study protocols in multisite clinical trials requires that all study personnel have 24/7 access to up-to-date study materials. Study websites can serve as an electronic manual of operations (eMOO) to support trial conduct. OBJECTIVE: We describe the development, organization, and maintenance of a study website and eMOO to facilitate quick and efficient communication during conduct of a complex, multisite, international clinical trial. METHODS: We worked closely with our information technology (IT) department to develop and maintain our study website, which includes a public home page, a section for parents and families, and three password-protected portals that serve as an eMOO for (a) study sites, (b) study site investigators, and (c) the operations team (e.g., clinical coordination center, data coordination center). RESULTS: The public home page is helpful for families contemplating study participation and for nonparticipating sites considering joining our trial. The patient and family education section supports family participation in the study. The study site portal contains all information needed for local study teams to safely manage a study patient. The investigator portal provides access to research-specific materials needed to lead the study at each site. The operations team portal supports overall study management. For other scientists considering use of a study website for their multisite research, we recommend close collaboration with IT for development and maintenance, limited and clearly defined roles for version control, and use of unmodifiable file formats to prevent unapproved alterations of study materials. DISCUSSION: While investment in development and maintenance has been significant, we have appreciated marked value to our operations team and study sites. Our study website development process is relevant to other scientists conducting multisite clinical research.

Trauma-Informed Care: Pediatric Intensive Care Nurses at the Root of Children's Safety and Trust.

Any experience that a child perceives as threatening or detrimental and has long-term consequences for the child's holistic health and welfare qualifies as trauma. Whether an experience is traumatic depends on the 3 E's of trauma: the event, the experience of the event, and the effects. Traumatic events can affect an infant's or child's development and have lifelong repercussions. Because of the prevalence of pediatric trauma, trauma-informed care has become the standard of care. Nurses are perfectly positioned to lead trauma-informed care in the pediatric intensive care unit. This article explores the components of trauma-informed care and the application of this standard of care to children in the pediatric intensive care unit. The nurse providing trauma-informed care understands the impact of trauma on the child, the family, and the staff and responds by integrating knowledge about trauma into care, both individually and systemwide, seeking to actively avoid retraumatization. This article presents the 6 principles of trauma-informed care and 3 case examples illustrating the application of these principles in the pediatric intensive care unit. Additional resources are provided to equip critical care nurses to fully implement this standard of care for critically ill children.

Creating a Research Agenda and Setting Research Priorities for Clinical Nurse Specialists.

PURPOSE/OBJECTIVES: The purpose of this article is to describe the evolution and results of the process for establishing a research agenda and identification of research priorities for clinical nurse specialists, approved by the National Association of Clinical Nurse Specialists (NACNS) membership and sanctioned by the NACNS Board of Directors. DESCRIPTION OF THE PROJECT/PROGRAM: Development of the research agenda and identification of the priorities were an iterative process and involved a review of the literature; input from multiple stakeholders, including individuals with expertise in conducting research serving as task force members, and NACNS members; and feedback from national board members. OUTCOME: A research agenda, which is to provide an enduring research platform, was established and research priorities, which are to be applied in the immediate future, were identified as a result of this process. CONCLUSION: Development of a research agenda and identification of research priorities are a key method of fulfilling the mission and goals of NACNS. The process and outcomes are described in this article.

Case Study of High-Dose Ketamine for Treatment of Complex Regional Pain Syndrome in the Pediatric Intensive Care Unit.

Complex regional pain syndrome (CRPS) is a life-altering and debilitating chronic pain condition. The authors are presenting a case study of a female who received high-dose ketamine for the management of her CRPS. The innovative treatment lies not only within the pharmacologic management of her pain, but also in the fact that she was the first patient to be admitted to our pediatric intensive care unit solely for pain control. The primary component of the pharmacotherapy treatment strategy plan was escalating-dose ketamine infusion via patient-controlled-analgesia approved by the pharmacy and therapeutics committee guided therapy for this patient. The expertise of advanced practice nurses blended exquisitely to ensure patient and family-centered care and the coordination of care across the illness trajectory. The patient experienced positive outcomes.

Parent Advocacy Group for Events of Resuscitation.

BACKGROUND: The presence of patients' families during resuscitation has been an important practice issue. An American Association of Critical-Care Nurses (AACN) practice alert "Family Presence During Resuscitation and Invasive Procedures" supports family members of patients undergoing resuscitation being given the option of bedside presence. Parent Advocacy Group for Events of Resuscitation (PAGER) is an interdisciplinary collaborative in the pediatric intensive care unit. OBJECTIVES: To ensure that patients' families are provided the option of being with their child during cardiopulmonary resuscitation. METHODS: Resuscitation data were collected for 12 months by using the AACN practice alert audit tool. The Family Nurse Caring Belief Scale was administered to 150 pediatric intensive care unit nurses. PAGER nurses received crisis education. RESULTS: Pediatric intensive care unit nurses were supportive of providing the option of family presence during resuscitation. Family Nurse Caring Belief Scale data revealed areas for improvement in family caring practices. PAGER was implemented with positive outcomes for 2 families. CONCLUSIONS: PAGER has improved the care of families whose children experience cardiopulmonary resuscitation and should be implemented in pediatric critical care units. PAGER nurses are prepared to serve as role models in providing family-sensitive care during crisis.

The headache electronic diary for children with concussion.

PURPOSE/OBJECTIVES: The purposes of the study were to (1) develop a prospective, real time, age-appropriate, and appealing prototype of an electronic headache pain diary for children and (2) evaluate the clinical feasibility and utility of the diary for the assessment and documentation of concussion headache. DESIGN: A mixed-methods design of qualitative interviews and a quantitative survey was used. SETTING: The setting was a sports medicine concussion clinic. SAMPLE: The sample included 2 independent groups of 30 children (females n = 36, males n = 24) each aged 12 to 17 years, with postconcussion headache and pediatric concussion expert clinicians (n = 5). METHODS: During phase 1 of the study, subjects were interviewed individually about their headaches and their ideas for an electronic diary. A prototype was developed using these children's interview data. In phase 2 of the study, both children and clinicians piloted the prototype. Clinicians' survey data regarding the feasibility and utility of the diary were examined using thematic and descriptive analyses. RESULTS: The phase 1 sample recommended a diary with calendar and clock functions, head views, menus (eg, pain descriptors), soft colors, a choice of pain assessment scales, and the ability to personalize it. All of the children thought that the new Headache Electronic Diary for Children With Concussion (HED-CC) would be helpful to track their headache and reported that other children with concussions would be likely to use it. Participants recommended improvement of the head views and clock function. In phase 2 of the study, all clinicians reported that the new HED-CC measure was feasible and useful for the assessment and documentation of headache. CONCLUSIONS: The new HED-CC provides for thorough assessment and documentation of postconcussion headache. Proactive, real-time measurement helps children remember the details of their headache pain and correlating events/circumstances. An appealing, age-appropriate measure increases the likelihood of children's symptom tracking and data accuracy. The HED-CC will improve clinicians' understanding of postconcussion headache and guide treatment. Additional testing with a larger sample is required to establish clinical application benefits and improve reliability/validity of the new measure.

Hospitalized infants who hurt: a sweet solution with oral sucrose.

Pain is harmful to newborn infants. Oral sucrose is safe, inexpensive, and effective at preventing and reducing pain in hospitalized babies who undergo invasive procedures. The sugar can be used alone or in combination with analgesics and other nonpharmacological interventions to provide analgesia. Parents expect nurses to serve as pain advocates for the parents' newborns and to protect the babies from needless suffering. It is incumbent upon nurses to stay abreast of the current evidence and integrate use of oral sucrose into daily pain management practice in emergency, acute, and critical care units.