Decision MakingBRIDGENCT07390773
Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE): An Intervention to Support Decision Making for Critically Ill Children
A study testing BRIDGE intervention in people with Decision Making and Neonatal Critical Illness, run by Duke University at 3 sites in United States.
Trial summary
Parents of young children in the intensive care unit may be faced with decisions about their child's care. The Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE) intervention was designed to help support parents as they make decisions for their child and communicate with the health care team. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Decision Making, Neonatal Critical Illness, Pediatric Critical Illness
- What is being tested?
- BRIDGE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Aug 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Child inclusion criteria will include:
- Age < 5 years
- Admission to a critical care unit within the preceding 14 days
- An anticipated serious health care decision, defined as a decision about initiating, not initiating, or withdrawing life-sustaining treatment and/or a decision about major intervention.
- Parent inclusion criteria will include:
- Age ≥ 18 years
Show all 10Show fewer
- The ability speak English or Spanish.
- Clinician inclusion criteria will include
- Clinical team member of an enrolled child and parent in the intervention group
- Completion of residency or equivalent training.
Who cannot join
- Children, parents or clinicians who do not meet the inclusion criteria above.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amanda Fristoe, MD contact
United States3 sites, 3 recruiting
- Not yet recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Jenny Shepard, 410-614-3834, jshepar1@jhmi.edu
Renee Boss, MD
- Recruiting
Duke University
Durham, North Carolina, 27705
Amanda Fristoe, 919-684-4833, amanda.fristoe@duke.edu
Monica Lemmon, MD
- Not yet recruiting
University of California San Francisco
San Francisco, California, 94143
Yasmeen Rezaishad, 415-476-3785, Yasmeen.Rezaishad@ucsf.edu
Hannah Glass, MD
About this study
Parents of young children in the intensive care unit may be faced with decisions about their child's care. The Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE) intervention was designed to help support parents as they make decisions for their child and communicate with the health care team. The main questions this study aims to answer are:
- Do parents who receive the BRIDGE intervention report being better prepared to make decisions for their child?
- Do parents who receive the BRIDGE intervention report less regret about the decisions they made for their child?
Participants will complete surveys at baseline and approximately 2 weeks, 6 months, and 12 months following enrollment. Some participants will also participate in interviews about their experiences.
- Being tested
- BRIDGE intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIDGE interventionBehavioural
The BRIDGE intervention includes a paper-based tool that includes an introduction to decision-making, a values clarification exercise, and a question prompt list. The tool additionally prompts parents to share how they define decision-relevant concepts like quality of life and suffering for their child. The completed tool is shared with the health care team in the electronic health record.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the BRIDGE intervention arm, parents will receive a paper-based tool that includes an introduction to decision-making, a values clarification exercise, and a question prompt list. The tool additionally prompts parents to share how they define decision-relevant concepts like quality of life and suffering for their child. The completed tool is shared with the medical team in the electronic health record. Receives: Behavioral: BRIDGE intervention |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Approximately 10-14 days following enrollment
Decisional Regret, as measured by the Decision Regret Scale
Decisional Regret will be measured by the Decision Regret Scale (DRS): The DRS is a 5- item scale used to measure distress or remorse after a health care decision.
Measured: Approximately 6 and 12 months following enrollment
Secondary outcomes (4)
Shared Decision Making Quality, as measured by the CollaboRATE (Parent version)
This survey is a 3-item measure, and each item can be rated from 0 to 9. Higher scores indicate a higher degree of shared decision making.
Measured: Approximately 10-14 days following enrollment
Communication Quality, as measured by the Interpersonal Processes of Care (IPC-18)
For this measure, we will administer the communication and decision making subscales. Each item uses a response scale of 1-5. Higher scores indicate that the labeled interpersonal process occurred more often.
Measured: Baseline; Approximately 10-14 days following enrollment
Decisional Conflict, as measured by the Decisional Conflict Scale
The Decisional Conflict Scale includes 16 items across 5 domains (score range: 0-100). Higher scores indicate a higher degree of decisional conflict.
Measured: Approximately 10-14 days following enrollment; Approximately 6 and 12 months following enrollment
Parent Self-efficacy, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions
Participants will complete the PROMIS self-efficacy for managing chronic conditions measure, which has been adapted for use by parents. This measure assesses parental self-efficacy in managing their child's medications and treatments. Participants will complete the questions in the health care information or decision making domain. Items ask participants to indicate their current level of confidence in each behavior and have 5 response options (range 1-5). Higher scores indicate a higher level of confidence.
Measured: Approximately 6 and 12 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start3 Aug 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision MakingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Monica Lemmon, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390773
- Sponsor's protocol ID
- Pro00117670
- Other IDs
- R01HD118955
- Acronym
- BRIDGE
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemmon 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE): An Intervention to Support Decision Making for Critically Ill Children
- ClinicalTrials.gov ID
- NCT07390773
- Acronym / sponsor ID
- BRIDGE / Pro00117670
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 5 Feb 2026 (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.
Parents of young children in the intensive care unit may be faced with decisions about their child's care. The Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE) intervention was designed to help support parents as they make decisions for their child and communicate with the health care team. The main questions this study aims to answer are:
- Do parents who receive the BRIDGE intervention report being better prepared to make decisions for their child?
- Do parents who receive the BRIDGE intervention report less regret about the decisions they made for their child?
Participants will complete surveys at baseline and approximately 2 weeks, 6 months, and 12 months following enrollment. Some participants will also participate in interviews about their experiences.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: BRIDGE interventionIn the BRIDGE intervention arm, parents will receive a paper-based tool that includes an introduction to decision-making, a values clarification exercise, and a question prompt list. The tool additionally prompts parents to share how they define decision-relevant concepts like quality of life and suffering for their child. The completed tool is shared with the medical team in the electronic health record. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age < 5 years
- Admission to a critical care unit within the preceding 14 days
- An anticipated serious health care decision, defined as a decision about initiating, not initiating, or withdrawing life-sustaining treatment and/or a decision about major intervention.
- Age ≥ 18 years
- The ability speak English or Spanish.
Key exclusion criteria (1 listed)
- Children, parents or clinicians who do not meet the inclusion criteria above.
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 |
|---|---|---|
| BRIDGE interventionThe BRIDGE intervention includes a paper-based tool that includes an introduction to decision-making, a values clarification exercise, and a question prompt list. The tool additionally prompts parents to share how they define decision-relevant concepts like quality of life and suffering for their child. The completed tool is shared with the health care team in the electronic health record. | Behavioural | Intervention |
Primary outcome
Parent Preparation for Decision Making, as measured by the PrepDM
Time frame: Approximately 10-14 days following enrollment
Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making.
Decisional Regret, as measured by the Decision Regret Scale
Time frame: Approximately 6 and 12 months following enrollment
Decisional Regret will be measured by the Decision Regret Scale (DRS): The DRS is a 5- item scale used to measure distress or remorse after a health care decision.
4 secondary outcomes
Shared Decision Making Quality, as measured by the CollaboRATE (Parent version)
Time frame: Approximately 10-14 days following enrollment
Communication Quality, as measured by the Interpersonal Processes of Care (IPC-18)
Time frame: Baseline; Approximately 10-14 days following enrollment
Decisional Conflict, as measured by the Decisional Conflict Scale
Time frame: Approximately 10-14 days following enrollment; Approximately 6 and 12 months following enrollment
Parent Self-efficacy, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions
Time frame: Approximately 6 and 12 months following enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: 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
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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.
Amanda Fristoe, MD contact
Monica Lemmon, MD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIDGE intervention in people with Decision Making and Neonatal Critical Illness, run by Duke University at 3 sites 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 10 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany Nave (919-684-8087, brittany.nave@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Preparation for Decision Making, as measured by the PrepDM (time frame: Approximately 10-14 days following enrollment). 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 NCT07390773, which also lists 1 linked publication.
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 8 Sep 2026.