Neonatal Critical IllnessNCT05733975
Decision Making Support for Parents and Caregivers
A study testing Decision Making Guide in people with Neonatal Critical Illness and Pediatric Critical Illness, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Neonatal Critical Illness, Pediatric Critical Illness
- What is being tested?
- Decision Making Guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year
- All sexes
- No healthy volunteers
- Child
Study participants will include English-speaking parents of critically ill infants and children admitted to Duke University Hospital.
Infant inclusion criteria will include
- age < 1 year,
- admission to a critical care unit, and
- an anticipated serious health care decision
All parents of eligible infants will be considered for inclusion. Parent exclusion criteria will include 1) age < 18 years, 2) hearing or speech impairment, and 3) non-English speakers.
All clinicians of eligible infants will be considered for inclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.
Read the detailed description
In this single-arm mixed methods prospective feasibility study, we will enroll infants, parents, and clinicians. The intervention is a paper-based decision guide that contains a values clarification exercise and question prompt list.
- Being tested
- Decision Making Guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Making GuideOther
The tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Infants | Other | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. Receives: Other: Decision Making Guide |
| Parent(s) of Critically Ill Infant | Other | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. Receives: Other: Decision Making Guide |
| Clinicians | Other | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. Receives: Other: Decision Making Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate (Critically Ill Infants)
Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.
Measured: At enrollment (approximately 9 months)
Complete Data Collection (Critically Ill Infants)
Complete data collection defined as all eligible infant, parent, and clinician data points collected for a given case and was determined at the level of the critically ill infant. Data points for which the participant withdrew prior to relevant data collection were excluded. Intervention and study procedures considered feasible if complete data collection rate is greater than or equal to 80%.
Measured: approximately 9 months
Secondary outcomes (3)
Parent and Clinician Acceptability
Acceptability will be measured using an acceptability questionnaire, consisting of close-ended items with 5-point likert scale response options (strongly disagree, disagree, neither agree or disagree, agree, strongly agree).
Measured: Up to 4 weeks following use of the tool
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS measures assess the extent to which patients experience challenges with symptoms over the past 7 days. Scores are derived using a standardized T-score metric, with a mean of 50 and a standard deviation of 10. Higher scores reflect greater symptom severity.
Measured: Baseline, and up to 4 weeks following use of the tool
Parent Preparation for Decision Making, as Measured by the PrepDM
Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making.
Measured: Up to 4 weeks following use of the tool
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start2 May 2023
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Neonatal Critical IllnessStudies of the same condition, open and under way.
- More trials run by Duke 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Monica Lemmon, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733975
- Sponsor's protocol ID
- Pro00111995
- Other IDs
- K23NS116453
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2023
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant level data
Publications
Lemmon ME, Boss RD, Bonifacio SL, Foster-Barber A, Barkovich AJ, Glass HC. Characterization of Death in Neonatal Encephalopathy in the Hypothermia Era. J Child Neurol. 2017 Mar;32(4):360-365. doi: 10.1177/0883073816681904. Epub 2016 Dec 20.
PubMed 28193115Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available.
PubMed 1556799Carlet J, Thijs LG, Antonelli M, Cassell J, Cox P, Hill N, Hinds C, Pimentel JM, Reinhart K, Thompson BT. Challenges in end-of-life care in the ICU. Statement of the 5th International Consensus Conference in Critical Care: Brussels, Belgium, April 2003. Intensive Care Med. 2004 May;30(5):770-84. doi: 10.1007/s00134-004-2241-5. Epub 2004 Apr 20.
PubMed 15098087White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461.
PubMed 17353493Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.
PubMed 10966293Curtis JR, Engelberg RA, Wenrich MD, Shannon SE, Treece PD, Rubenfeld GD. Missed opportunities during family conferences about end-of-life care in the intensive care unit. Am J Respir Crit Care Med. 2005 Apr 15;171(8):844-9. doi: 10.1164/rccm.200409-1267OC. Epub 2005 Jan 7.
PubMed 15640361Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63.
PubMed 22635048Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.
PubMed 28402085Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.
PubMed 30690645Boss RD, Hutton N, Sulpar LJ, West AM, Donohue PK. Values parents apply to decision-making regarding delivery room resuscitation for high-risk newborns. Pediatrics. 2008 Sep;122(3):583-9. doi: 10.1542/peds.2007-1972.
PubMed 18762529Zupancic JA, Kirpalani H, Barrett J, Stewart S, Gafni A, Streiner D, Beecroft ML, Smith P. Characterising doctor-parent communication in counselling for impending preterm delivery. Arch Dis Child Fetal Neonatal Ed. 2002 Sep;87(2):F113-7. doi: 10.1136/fn.87.2.f113.
PubMed 12193517Lemmon ME, Bansal S, Nanduri N, Davalos A, Glass HC, Lord B, Moline K, Pilon B, Sharpe R, Brandon D, Hong H, Samsa G, Cox CE, Pollak KI. Feasibility of an Intervention to Support Shared Decision-Making for Critically Ill Infants. J Pediatr. 2025 Aug;283:114632. doi: 10.1016/j.jpeds.2025.114632. Epub 2025 May 2.
PubMed 40319938
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making Support for Parents and Caregivers
- ClinicalTrials.gov ID
- NCT05733975
- Acronym / sponsor ID
- Pro00111995
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.
Detailed description
In this single-arm mixed methods prospective feasibility study, we will enroll infants, parents, and clinicians. The intervention is a paper-based decision guide that contains a values clarification exercise and question prompt list.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Infants | Other | Other: Decision Making GuideParent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
| Parent(s) of Critically Ill Infant | Other | Other: Decision Making GuideParent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
| Clinicians | Other | Other: Decision Making GuideParent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Decision Making GuideThe tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list. | Other | Clinicians, Critically Ill Infants, Parent(s) of Critically Ill Infant |
Primary outcome
Enrollment Rate (Critically Ill Infants)
Time frame: At enrollment (approximately 9 months)
Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.
Complete Data Collection (Critically Ill Infants)
Time frame: approximately 9 months
Complete data collection defined as all eligible infant, parent, and clinician data points collected for a given case and was determined at the level of the critically ill infant. Data points for which the participant withdrew prior to relevant data collection were excluded. Intervention and study procedures considered feasible if complete data collection rate is greater than or equal to 80%.
3 secondary outcomes
Parent and Clinician Acceptability
Time frame: Up to 4 weeks following use of the tool
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline, and up to 4 weeks following use of the tool
Parent Preparation for Decision Making, as Measured by the PrepDM
Time frame: Up to 4 weeks following use of the tool
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28193115Lemmon ME, Boss RD, Bonifacio SL, Foster-Barber A, Barkovich AJ, Glass HC. Characterization of Death in Neonatal Encephalopathy in the Hypothermia Era. J Child Neurol. 2017 Mar;32(4):360-365. doi: 10.1177/0883073816681904. Epub 2016 Dec 20.
- Background: PubMed 1556799Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available.
- Background: PubMed 15098087Carlet J, Thijs LG, Antonelli M, Cassell J, Cox P, Hill N, Hinds C, Pimentel JM, Reinhart K, Thompson BT. Challenges in end-of-life care in the ICU. Statement of the 5th International Consensus Conference in Critical Care: Brussels, Belgium, April 2003. Intensive Care Med. 2004 May;30(5):770-84. doi: 10.1007/s00134-004-2241-5. Epub 2004 Apr 20.
- Background: PubMed 17353493White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461.
- Background: PubMed 10966293Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.
- Background: PubMed 15640361Curtis JR, Engelberg RA, Wenrich MD, Shannon SE, Treece PD, Rubenfeld GD. Missed opportunities during family conferences about end-of-life care in the intensive care unit. Am J Respir Crit Care Med. 2005 Apr 15;171(8):844-9. doi: 10.1164/rccm.200409-1267OC. Epub 2005 Jan 7.
- Background: PubMed 22635048Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63.
- Background: PubMed 28402085Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.
- Background: PubMed 30690645Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.
- Background: PubMed 18762529Boss RD, Hutton N, Sulpar LJ, West AM, Donohue PK. Values parents apply to decision-making regarding delivery room resuscitation for high-risk newborns. Pediatrics. 2008 Sep;122(3):583-9. doi: 10.1542/peds.2007-1972.
- Background: PubMed 12193517Zupancic JA, Kirpalani H, Barrett J, Stewart S, Gafni A, Streiner D, Beecroft ML, Smith P. Characterising doctor-parent communication in counselling for impending preterm delivery. Arch Dis Child Fetal Neonatal Ed. 2002 Sep;87(2):F113-7. doi: 10.1136/fn.87.2.f113.
- Derived from this study: PubMed 40319938Lemmon ME, Bansal S, Nanduri N, Davalos A, Glass HC, Lord B, Moline K, Pilon B, Sharpe R, Brandon D, Hong H, Samsa G, Cox CE, Pollak KI. Feasibility of an Intervention to Support Shared Decision-Making for Critically Ill Infants. J Pediatr. 2025 Aug;283:114632. doi: 10.1016/j.jpeds.2025.114632. Epub 2025 May 2.
- Individual participant dataSharing planned: No. There is no plan to share individual participant level data
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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.
Monica Lemmon, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Making Guide in people with Neonatal Critical Illness and Pediatric Critical Illness, run by Duke 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?
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 18 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Enrollment Rate (Critically Ill Infants) (time frame: At enrollment (approximately 9 months)). The study lists 2 primary outcomes in all. 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 NCT05733975, which also lists 12 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 18 Mar 2025.