Parent EngagementNCT04373915
Evaluating Parent Engagement, Attachment, Stress, and Satisfaction With Remote Rounding in the NICU
A study testing Remote Bedside Rounding in people with Parent Engagement and Parent Attachment, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The admission of a newborn child to the neonatal intensive care unit (NICU) is among the most distressing situations that parents can face. There are many sources of parental stress including loss of control and competing demands outside of the NICU involving work and other children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parent Engagement, Parent Attachment, Parent Stress
- What is being tested?
- Remote Bedside Rounding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents with an infant admitted to the NICU/R4 with an anticipated length of stay of 2 weeks or more
- Parent consents to study and answering questionnaires
- English speaking
- Infant is assigned to red or purple medical service team.
- Infant age at enrollment: zero to 14 days old
Who cannot join
- Parents with an infant admitted to the NICU/R4 with an anticipated length of stay less than 2 weeks
- Parent is not willing to answer questionnaires
- Non-English speaking
- Patient is not assigned to red or purple medical service team.
- Discharge to other than biological parents expected
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
About this study
Official title: Improving Family Engagement With Remote Rounding in the NICU
The admission of a newborn child to the neonatal intensive care unit (NICU) is among the most distressing situations that parents can face. There are many sources of parental stress including loss of control and competing demands outside of the NICU involving work and other children. During a prolonged admission it is often difficult for families to be present at bedside rounds on a daily basis and thus more difficult to discuss and collaborate with families in the care of their child. Healthcare has been slower than many other fields to adapt to the availability of new technology. This study hypothesizes that the use of wireless technology to allow parents to remotely participate on rounds would improve parental stress and satisfaction, in addition to improving engagement and attachment to their infant.
Read the detailed description
Every year 10 to 15 percent of infants born in the United States, totaling roughly half a million babies, are admitted to a Neonatal Intensive Care Unit (NICU). Although survival rates are generally high, as many as half of these infants require a prolonged hospital stay. For parents, the admission of a newborn to the NICU is among the most emotionally distressing situations that they can face. A prolonged hospital stay can further impact the mother and family physically, psychologically, and financially.
During admission in the NICU it is often difficult for families to be present at bedside rounds on a daily basis due to transportation challenges or competing demands of work and care for siblings. Conflicting schedules between families and doctors make it more difficult to discuss and collaborate with families in the care of their child. The investigators hypothesize that this deficiency of communication and perceived loss of control can have significant impacts on maternal stress, satisfaction, engagement, and attachment.
Outside of the medical field, technology continues to advance as rapidly as ever. The medical field continues to struggle with adapting and using new technology and continue to lag behind many other fields. In recent years telemedicine has been used to facilitate patient care delivery, improve accessibility of health care services, and reduce healthcare costs however this use remains largely in the outpatient sector.
In the Neonatal Intensive Care Unit, Telemedicine has been used by one group to improve parent satisfaction in a variety of areas. A pilot study of the concept of remote or virtual rounding in a Pediatric Intensive Care Unit has been recently published in the literature. This project seeks to expand upon this knowledge to define and measure the impact on several aspects of neonatal care.
- Conditions
- Parent Engagement, Parent Attachment, Parent Stress
- Being tested
- Remote Bedside Rounding
- Keywords
- NICU, parent engagement, parent attachment, parent stress, remote rounding, video rounding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Bedside RoundingBehavioural
Parents of infants on the medical team utilizing remote rounding will have the opportunity to participate in rounds by video conferencing at the infant's bedside. Participation will be tracked and surveys regarding stress, satisfaction, and attachment will be completed by parents in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Standard Bedside Rounding | No intervention | Not described |
| Remote Bedside Rounding | Experimental | Parents of infants on one care team will have the opportunity to participate in rounds via secure remote video software. Receives: Behavioral: Remote Bedside Rounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Engagement
Calendars will be placed at each infant's bedside to record engagement events consisting of participation in rounds, phone calls, visits, and kangaroo care. Each parental interaction recorded on the calendar will be counted. The mean and standard deviation of interactions over the study period will be calculated for each arm.
Measured: up to 1 year.
Secondary outcomes (3)
Parent Satisfaction: survey
A short investigator created satisfaction survey will be used to measure parent satisfaction. Each question on the parent satisfaction survey will be analyzed separately and compared between the two groups. A Mann-Whitney U test will be used for each of the 8 likert questions.
Measured: up to 6-10 weeks
Parent Stress
The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) will be used to measure parent stress. The instrument is a 46-item scale with 3 sub scales: infant behavior and appearance, parental role alteration, and sights and sounds. Each item is scored 1-5 on a likert scale (total sore range 46-230) with higher scores relating to higher stress. A standard t-test will be used.
Measured: up to 6-10 weeks
Parent Attachment survey
The Maternal Attachment Inventory will be used to measure parent-infant attachment. This is a 26 item scale with each item scoring 1-4, for a total possible score of 26-104 with a higher score showing better attachment. Differences in attachment between the two arms will be assessed using a Wilcoxon rank sum test.
Measured: up to 6-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jul 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Low participation in intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parent EngagementStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single site prospective cohort study. Participants will be block randomized to standard rounding or availability of remote rounding based on their medical care team in the NICU. Parents using remote rounding will be compared to those who do not utilize remote rounding.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Carly Dykstra, University Hospitals Cleveland Medical Center
- Investigators
- Margaret Kuper-Sasse, MD, Principal investigator, Rainbow Babies and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373915
- Sponsor's protocol ID
- STUDY20181178
- Status last verified
- Jan 2022
- First submitted
- 18 Apr 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
PubMed 8506163Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.
PubMed 7780768Gray JE, Safran C, Davis RB, Pompilio-Weitzner G, Stewart JE, Zaccagnini L, Pursley D. Baby CareLink: using the internet and telemedicine to improve care for high-risk infants. Pediatrics. 2000 Dec;106(6):1318-24. doi: 10.1542/peds.106.6.1318.
PubMed 11099583Epstein EG, Sherman J, Blackman A, Sinkin RA. Testing the Feasibility of Skype and FaceTime Updates With Parents in the Neonatal Intensive Care Unit. Am J Crit Care. 2015 Jul;24(4):290-6. doi: 10.4037/ajcc2015828.
PubMed 26134328Yager PH, Clark M, Cummings BM, Noviski N. Parent Participation in Pediatric Intensive Care Unit Rounds via Telemedicine: Feasibility and Impact. J Pediatr. 2017 Jun;185:181-186.e3. doi: 10.1016/j.jpeds.2017.02.054. Epub 2017 Mar 28.
PubMed 28363361
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Family Engagement With Remote Rounding in the NICU
- ClinicalTrials.gov ID
- NCT04373915
- Acronym / sponsor ID
- STUDY20181178
- Conditions
- Parent Engagement, Parent Attachment, Parent Stress
- Keywords
- NICU, parent engagement, parent attachment, parent stress, remote rounding, video rounding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low participation in intervention
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 May 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 admission of a newborn child to the neonatal intensive care unit (NICU) is among the most distressing situations that parents can face. There are many sources of parental stress including loss of control and competing demands outside of the NICU involving work and other children. During a prolonged admission it is often difficult for families to be present at bedside rounds on a daily basis and thus more difficult to discuss and collaborate with families in the care of their child. Healthcare has been slower than many other fields to adapt to the availability of new technology. This study hypothesizes that the use of wireless technology to allow parents to remotely participate on rounds would improve parental stress and satisfaction, in addition to improving engagement and attachment to their infant.
Detailed description
Every year 10 to 15 percent of infants born in the United States, totaling roughly half a million babies, are admitted to a Neonatal Intensive Care Unit (NICU). Although survival rates are generally high, as many as half of these infants require a prolonged hospital stay. For parents, the admission of a newborn to the NICU is among the most emotionally distressing situations that they can face. A prolonged hospital stay can further impact the mother and family physically, psychologically, and financially.
During admission in the NICU it is often difficult for families to be present at bedside rounds on a daily basis due to transportation challenges or competing demands of work and care for siblings. Conflicting schedules between families and doctors make it more difficult to discuss and collaborate with families in the care of their child. The investigators hypothesize that this deficiency of communication and perceived loss of control can have significant impacts on maternal stress, satisfaction, engagement, and attachment.
Outside of the medical field, technology continues to advance as rapidly as ever. The medical field continues to struggle with adapting and using new technology and continue to lag behind many other fields. In recent years telemedicine has been used to facilitate patient care delivery, improve accessibility of health care services, and reduce healthcare costs however this use remains largely in the outpatient sector.
In the Neonatal Intensive Care Unit, Telemedicine has been used by one group to improve parent satisfaction in a variety of areas. A pilot study of the concept of remote or virtual rounding in a Pediatric Intensive Care Unit has been recently published in the literature. This project seeks to expand upon this knowledge to define and measure the impact on several aspects of neonatal care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single site prospective cohort study. Participants will be block randomized to standard rounding or availability of remote rounding based on their medical care team in the NICU. Parents using remote rounding will be compared to those who do not utilize remote rounding.
| Arm | Type | Receives |
|---|---|---|
| Standard Bedside Rounding | No intervention | – |
| Remote Bedside Rounding | Experimental | Behavioral: Remote Bedside RoundingParents of infants on one care team will have the opportunity to participate in rounds via secure remote video software. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parents with an infant admitted to the NICU/R4 with an anticipated length of stay of 2 weeks or more
- Parent consents to study and answering questionnaires
- English speaking
- Infant is assigned to red or purple medical service team.
- Infant age at enrollment: zero to 14 days old
Key exclusion criteria (5 listed)
- Parents with an infant admitted to the NICU/R4 with an anticipated length of stay less than 2 weeks
- Parent is not willing to answer questionnaires
- Non-English speaking
- Patient is not assigned to red or purple medical service team.
- Discharge to other than biological parents expected
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 |
|---|---|---|
| Remote Bedside RoundingParents of infants on the medical team utilizing remote rounding will have the opportunity to participate in rounds by video conferencing at the infant's bedside. Participation will be tracked and surveys regarding stress, satisfaction, and attachment will be completed by parents in both groups. | Behavioural | Remote Bedside Rounding |
Primary outcome
Parent Engagement
Time frame: up to 1 year.
Calendars will be placed at each infant's bedside to record engagement events consisting of participation in rounds, phone calls, visits, and kangaroo care. Each parental interaction recorded on the calendar will be counted. The mean and standard deviation of interactions over the study period will be calculated for each arm.
3 secondary outcomes
Parent Satisfaction: survey
Time frame: up to 6-10 weeks
Parent Stress
Time frame: up to 6-10 weeks
Parent Attachment survey
Time frame: up to 6-10 weeks
Results and safety
The study was stopped early (reason given: Low participation in intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background: PubMed 8506163Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
- Background: PubMed 7780768Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.
- Background: PubMed 11099583Gray JE, Safran C, Davis RB, Pompilio-Weitzner G, Stewart JE, Zaccagnini L, Pursley D. Baby CareLink: using the internet and telemedicine to improve care for high-risk infants. Pediatrics. 2000 Dec;106(6):1318-24. doi: 10.1542/peds.106.6.1318.
- Background: PubMed 26134328Epstein EG, Sherman J, Blackman A, Sinkin RA. Testing the Feasibility of Skype and FaceTime Updates With Parents in the Neonatal Intensive Care Unit. Am J Crit Care. 2015 Jul;24(4):290-6. doi: 10.4037/ajcc2015828.
- Background: PubMed 28363361Yager PH, Clark M, Cummings BM, Noviski N. Parent Participation in Pediatric Intensive Care Unit Rounds via Telemedicine: Feasibility and Impact. J Pediatr. 2017 Jun;185:181-186.e3. doi: 10.1016/j.jpeds.2017.02.054. Epub 2017 Mar 28.
- Individual participant dataSharing planned: No
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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.
Margaret Kuper-Sasse, MD principal investigator
Rainbow Babies and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Bedside Rounding in people with Parent Engagement and Parent Attachment, run by University Hospitals Cleveland Medical Center 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 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 was stopped early (reason given: Low participation in intervention). Results are not available in the source record.
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?
Parent Engagement (time frame: up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04373915, which also lists 5 linked publications.
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 15 Feb 2022; AzTrials last refreshed its copy on 1 Nov 2026.