FeverNCT04328909
Study of an App to Facilitate Communication With Parents of Febrile Infants
A study testing E-Care in people with Fever, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 60 days
- Conditions the study is for
- Fever
- What is being tested?
- E-Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 9 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric emergency medicine fellows and attending physicians from Yale School of Medicine (Section of Pediatric Emergency Medicine)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06512
About this study
Official title: Pilot Trial of a Software Application to Facilitate Communication and Shared Decision-making With Parents of Febrile Infants
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)
Read the 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.
- Conditions
- Fever
- Being tested
- E-Care, Control Group
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CareDevice
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
Control GroupOther
Usual care - No E-Care app will be provided
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: E-Care |
| Control Group | Active comparator | Usual care - No E-Care app will be provided Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Secondary outcomes (12)
Knowledge questionnaire
8 statements (True, False, Unsure), scored as a proportion of correct responses (minimum 0, maximum 8). Higher proportion of correct responses = higher knowledge. Administration time is 1-2 minutes.This will be measured in both parents of infants <= 28 days and parents of infants 29 to 60 days.
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Anxiety Questionnaire
This is a six-item version of the State-Trait Anxiety Inventory. There are 6 statements about how the parent feels at that moment (4-point Likert scale, rated from "Not at all" to "Very much so"). Scored from 6 to 24, with higher scores indicating higher anxiety. Administration time is 1 minute. This will be measured in both parents of infants <= 28 days and parents of infants 29 to 60 days.
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Anxiety Questionnaire
This is a six-item version of the State-Trait Anxiety Inventory. There are 6 statements about how the parent feels at that moment (4-point Likert scale, rated from "Not at all" to "Very much so"). Scored from 6 to 24, with higher scores indicating higher anxiety. Administration time is 1 minute. This will be measured in both parents of infants <= 28 days and parents of infants 29 to 60 days.
Measured: Administered 1 week after emergency department visit
Acceptability of e-Care for parents of infants <= 28 days
One question with 3 statements asking parents how information was presented in the app (4-point scale, rated as "Poor" to "Excellent"), scored from 3 to 12 with higher scores=greater acceptability; Two questions asking about the length of the app and the amount of information presented (3-point scale, "Too short," "Too long," "Just right"); two questions asking ease of use and how helpful the app was (4-point scales); 2 open-ended questions; higher scores indicate greater acceptability. Administration time is 2-3 minutes.
Measured: 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
One question with 4 statements asking parents how information was presented in the app (4-point scale, rated as "Poor" to "Excellent"), scored from 4 to 16 with higher scores=greater acceptability; Two questions asking about the length of the app and the amount of information presented (3-point scale, "Too short," "Too long," "Just right"); one question asking about balance in presentation of options (3-point scale); three questions asking ease of use and how helpful the app was (4-point scales); 2 open-ended questions; higher scores indicate greater acceptability. Administration time is 2-3 minutes.
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Acceptability of E-Care for physicians
10 statements (5-point Likert scale, Strongly Disagree to Strongly Agree). Scored from 10 to 50, with higher scores = greater acceptability. Administration time is 1-2 minutes.
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Decision Regret scale
This is a 5 statements 5-point Likert scale, Strongly Disagree to Strongly Agree. Scored from 0 (no regret) to 100 (high regret). This will be measured in parents of infants 29 to 60 days
Measured: Administered 1 week after emergency department visit
Decisional conflict scale
This is a 10 statements (Yes, Unsure, No). Scored from 0 (no decisional conflict) to 100 (extremely high decisional conflict).This will only be measured for the parents of infants 29 to 60 days.
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Values questionnaire
This is a 2 questions with 2 statements each, whereby parents choose which of the 2 statements are more important to them (no score). Administration time 1 minute. This will be measured in the parents of infants 29 to 60 days
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Verbal question for parents of infants <= 28 days
Qualitative verbal question whether they viewed the app. This will be measured qualitatively (no score).
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Verbal questions for parents of infants 29 to 60 days
Qualitative verbal question whether they viewed the app and whether physicians showed them information in the app (intervention group only). This will be measured qualitatively (no score).
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Verbal questions for parents for physicians
about the app (if caring for parent in the intervention group) and question about how they communicated to parents (both groups). This will be measured qualitatively (no score).
Measured: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start8 Jun 2020
- Primary completion28 Jul 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328909
- Sponsor's protocol ID
- 2000027687
- Other IDs
- 1K08HS026006-01A1
- Status last verified
- Feb 2022
- First submitted
- 19 Mar 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of a Software Application to Facilitate Communication and Shared Decision-making With Parents of Febrile Infants
- ClinicalTrials.gov ID
- NCT04328909
- Acronym / sponsor ID
- 2000027687
- Conditions
- Fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-Care | Experimental | Device: E-CareParent-centered care software application (e-Care) to ensure parents of febrile infants are optimally informed and participate in shared decision making in the ED |
| Control Group | Active comparator | Other: Control GroupUsual care - No E-Care app will be provided |
Who may qualify
- Ages
- 1 day to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric emergency medicine fellows and attending physicians from Yale School of Medicine (Section of Pediatric Emergency Medicine)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-CareParent-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 GroupUsual care - No E-Care app will be provided | Other | Control Group |
Primary outcome
COMRADE scale
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
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.
12 secondary outcomes
Knowledge questionnaire
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Anxiety Questionnaire
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Anxiety Questionnaire
Time frame: Administered 1 week after emergency department visit
Acceptability of e-Care for parents of infants <= 28 days
Time frame: 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
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Acceptability of E-Care for physicians
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Decision Regret scale
Time frame: Administered 1 week after emergency department visit
Decisional conflict scale
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Values questionnaire
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Verbal question for parents of infants <= 28 days
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Verbal questions for parents of infants 29 to 60 days
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Verbal questions for parents for physicians
Time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Care in people with Fever, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMRADE scale (time frame: Administered at the end of the emergency department visit (4 hours after delivery of the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.