Study of an App to Facilitate Communication With Parents of Febrile Infants

NCT04328909 | Completed

• 2 other identifiers: 20000276871K08HS026006-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• COMRADE scale

  This is a 20 statements survey (5-point Likert scale, Strongly Disagree to Strongly Agree). It is scored from 20 to 100. Higher scores indicate better respondent (parent) perceptions of risk communication and their confidence in the decision. Administration time is 2-3 minutes. This will be measured in both parents of infants \<= 28 days and parents of infants 29 to 60 days.

  Administered at the end of the emergency department visit (4 hours after delivery of the intervention)

Secondary Outcomes (12)

• Knowledge questionnaire

  Administered at the end of the emergency department visit (4 hours after delivery of the intervention)

• Anxiety Questionnaire

  Administered at the end of the emergency department visit (4 hours after delivery of the intervention)

• Anxiety Questionnaire

  Administered 1 week after emergency department visit

• Acceptability of e-Care for parents of infants <= 28 days

  Administered at the end of the emergency department visit (4 hours after delivery of the intervention)

• Acceptability of e-Care for parents of infants 29 to 60 days

  Administered at the end of the emergency department visit (4 hours after delivery of the intervention)

Study Arms (2)

E-Care

EXPERIMENTAL

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

Device: E-Care

Control Group

ACTIVE COMPARATOR

Usual care - No E-Care app will be provided

Other: Control Group

Interventions

E-Care DEVICE

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

E-Care

Control Group OTHER

Usual care - No E-Care app will be provided

Control Group

Eligibility Criteria

• Age: 1 Day - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

MeSH Terms

Conditions

Fever

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: April 1, 2020
• Study Start: June 8, 2020
• Primary Completion: July 28, 2021
• Study Completion: August 9, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

US (1)