Clinical trial NCT04328909: Study of an App to Facilitate Communication With Parents of Febrile Infants
Official title: Pilot Trial of a Software Application to Facilitate Communication and Shared Decision-making With Parents of Febrile Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-04-01
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria for Parents - Parents of febrile infants ≤60 days of age (fever defined as a documented temperature of ≥38.0° C (100.4° F) in the ED or within the past 24 hours at home or in clinic)

Exclusion Criteria for Parents -

* Not comfortable with conversational and written English or Spanish
* Infant is critically ill and requiring life-saving interventions on arrival to the ED (e.g., endotracheal intubation, CPR)
* Parent has been previously enrolled

Inclusion Criteria for Physicians -

- Pediatric emergency medicine fellows and attending physicians from Yale School of Medicine (Section of Pediatric Emergency Medicine)

Exclusion Criteria for Physicians - none

Primary outcomes:
measure: COMRADE scale
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Secondary outcomes:
measure: Knowledge questionnaire
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Anxiety Questionnaire
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Anxiety Questionnaire
timeFrame: Administered 1 week after emergency department visit
measure: Acceptability of e-Care for parents of infants <= 28 days
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Acceptability of e-Care for parents of infants 29 to 60 days
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Acceptability of E-Care for physicians
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Decision Regret scale
timeFrame: Administered 1 week after emergency department visit
measure: Decisional conflict scale
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Values questionnaire
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Verbal question for parents of infants <= 28 days
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Verbal questions for parents of infants 29 to 60 days
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
measure: Verbal questions for parents for physicians
timeFrame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References: