Study of an App to Facilitate Communication With Parents of Febrile Infants
Condition: Fever
MeSH terms: Hyperthermia; Fever
Study type: Interventional

Summary: 
      The objective of this research project is to test an evidence-based parent-centered care
      software application (e-Care) to ensure that parents of febrile infants from a wide range of
      socio-demographic backgrounds are optimally informed despite being fatigued and stressed, and
      able to participate in shared decision making (SDM) in the unfamiliar, time-pressured
      environment of the Emergency Department (ED)
    

Detailed description: 
      Recruitment and Consent: Pediatric emergency medicine fellows and attending physicians will
      be enrolled at a Section meeting or individually and not during patient care in the ED.
      Written informed consent will be obtained. For physicians who decline enrollment, parents of
      febrile infants will not be approached for enrollment. Each pediatric emergency medicine
      fellow and attending physician will be assigned a unique study identifier.

      Parents will be enrolled in the Yale New Haven Children's Hospital pediatric ED. The RA or PI
      will be notified by the triage nurse, bedside nurse, or treating pediatric emergency medicine
      fellow or attending physician of an eligible parent of a febrile infant, defined as an infant
      with a documented temperature of ≥38.0° C (100.4° F) in the ED or within the past 24 hours at
      home or in clinic who is evaluated in the pediatric ED at Yale New Haven Children's Hospital.
      After introduction by the treating medical team, the RA or PI will approach eligible
      parent(s) for enrollment when they are in the ED examination room and after initial
      discussion with the pediatric emergency medicine fellow or attending physician. Study
      procedures and the risks/benefits of participating will be described, and written informed
      consent will be obtained. When more than one parent is available, the parents will be asked
      to identify who will complete all study forms.

      All parents will receive a unique study identifier. This unique study identifier will be
      linked to the signed informed consent document and to the infant's MRN. The infant's MRN will
      be recorded on an excel file stored on the Yale ITS managed, encrypted, password-protected
      laptop that is stored in the PI's locked office.

      Baseline (Month 1): Parents will complete a baseline demographics form (please see Data
      Collection below) and will complete an outcome measures survey at the time of disposition
      from the ED and 1 week after the ED visit

      Intervention (e-Care) Group: After enrollment of a parent, the RA or PI will provide a brief
      orientation of e-Care to the treating pediatric emergency medicine fellow and/or attending
      physician, including showing the "What happens after the test results are known" section for
      parents of infants 29-60 days of age. The parent will complete a baseline demographics
      form.The e-Care app will then be provided to the parent on an iPad with a brief overview of
      the app provided by the RA or PI. The parent will then view the e-Care app at his or her
      discretion throughout the duration of the ED visit. At the time of disposition from the ED,
      parents will complete an outcome measures survey and an acceptability survey, and 1 week
      after the ED visit, parents will complete another outcome measures survey. Parents will also
      answer brief qualitative questions at the time of disposition.The RA or PI will extract
      de-identified data on the infant from the Epic electronic health record and will confirm some
      of the data on a phone call with parents 1 week after the ED visit. Physicians will complete
      an acceptability survey and answer brief qualitative questions at the time of the infant's
      disposition from the ED.

      Control Group: For parents/febrile infant dyads who are randomized to usual care, no e-Care
      app will be provided. Outcome measures will be completed as described for the Intervention
      group, with the exception that no acceptability surveys or qualitative questions will be
      completed by parents and no acceptability survey will be completed by physicians.
    

Intervention name(s): E-Care; Control Group
Intervention type(s): Device; Other
Intervention description(s): Parent-centered care software application (e-Care) to ensure parents of febrile infants are optimally informed and participate in shared decision making in the ED; Usual care - No E-Care app will be provided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment