BRIDGE Intervention for Decision Making in Severe Illness

(BRIDGE Trial)

Not yet recruiting at 2 trial locations
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AF
Overseen ByAmanda Fristoe, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support program called the BRIDGE intervention. It aims to assist parents of young children in intensive care with making crucial treatment decisions and improving communication with doctors. The trial seeks to determine if parents feel more prepared and experience less regret about their decisions. Participants will complete surveys and possibly interviews over a year. Parents with children under 5 who have recently been in critical care and are facing difficult treatment choices may be suitable candidates.

As an unphased trial, this study provides a unique opportunity for parents to contribute to research that could enhance decision-making support for families in similar situations.

What prior data suggests that the BRIDGE intervention is safe for parents of young children in the intensive care unit?

Research shows that the BRIDGE intervention is designed to help parents make better decisions about their child's care in the intensive care unit. Although specific safety studies on this exact tool are lacking, similar decision support tools have demonstrated benefits, such as reducing anxiety and boosting confidence in decision-making.

What does this mean for safety? Since the intervention provides support and guidance through a paper-based tool, it doesn't involve taking any medicines. Therefore, it lacks typical "side effects" associated with drugs. Instead, it aims to help parents feel more prepared and less regretful about tough decisions.

In similar programs, parents reported feeling less stressed and more informed. This suggests that the BRIDGE intervention is likely safe and doesn't carry risks of physical harm.12345

Why are researchers excited about this trial?

Researchers are excited about the BRIDGE Intervention because it offers a new approach to decision-making for parents of children with severe illnesses. While typical care often involves direct conversations with medical teams, this intervention provides a paper-based tool that helps parents clarify their values and articulate their understanding of key concepts like quality of life and suffering. The completed tool is then shared with the medical team through the electronic health record, ensuring that parents' perspectives are clearly communicated. This method empowers parents to make more informed decisions and fosters better collaboration with healthcare providers.

What evidence suggests that the BRIDGE intervention is effective for decision making in severe illness?

Research has shown that the BRIDGE program is helpful in various situations. For instance, one study found it made cancer treatment more consistent by reducing disruptions. Another study demonstrated that the BRIDGE model lowered emergency room visits for people with serious mental health issues. These results suggest that the BRIDGE program can help people make better decisions and feel less stressed in tough situations. In this trial, parents in the BRIDGE intervention arm will receive a paper-based tool to aid in decision-making, potentially assisting parents facing difficult choices in the intensive care unit.23678

Who Is on the Research Team?

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Monica Lemmon, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for parents with critically ill children in the neonatal intensive care unit. It aims to support them in making healthcare decisions. There's no specific inclusion or exclusion criteria provided, so it may be open to any parent facing such circumstances.

Inclusion Criteria

My child is under 5, was in critical care recently, and faces a serious health decision.
Clinician: Clinical team member of an enrolled child and parent in the intervention group, Completion of residency or equivalent training
I am over 18 and speak English or Spanish.

Exclusion Criteria

Children, parents, or clinicians who do not meet the inclusion criteria above.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents receive the BRIDGE intervention, which includes a paper-based tool for decision-making support

2 weeks
1 visit (in-person)

Follow-up

Participants complete surveys and interviews to assess decision-making preparedness and regret

12 months
Surveys at baseline, 2 weeks, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • BRIDGE Intervention

Trial Overview

The BRIDGE intervention is being tested to see if it helps parents feel more prepared and less regretful about their decisions regarding their child's care. The study includes surveys and interviews over a period of up to 12 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

Bridge: Person‐Centered Collaborative Care for Patients with ...

This study found that it was feasible to identify, enroll, and retain patients with serious mental illness and a new cancer in a trial of integrated mental ...

Service Use by Medicaid Recipients With Serious Mental ...

Conclusions: The Bridge was effective in decreasing emergency room use among individuals with serious mental illnesses.

A randomized trial of person-centered collaborative care ...

Patients assigned to BRIDGE were significantly less likely to experience cancer care disruptions compared to those receiving EUC (17.2% vs 35.1% ...

Emergency Department Bridge Model and Health Services ...

Patients referred to the bridge clinic had a 32% risk of subsequent ED use compared with a 24% risk for usual care patients (risk differences=7.5%, 95% ...

A Randomized Controlled Trial of Mental Health Peer-Led ...

This randomized controlled trial tests the efficacy of a mental health peer-led educational intervention called BRIDGES (Building Recovery of Individual ...

Treatment Outcomes of a Crisis Intervention Program for ...

The Bridge project significantly reduced patient anxiety, depression, resistance to care, impulsive behavior, verbal outbursts, and wandering.

Decision-making and related outcomes of patients with ...

Decision support interventions aim to address decisional needs by (a) resolving decisional conflict, (b) improving knowledge and information ...

The ecosystem of health decision making

The concept describes how the different actors could agree on outcomes that matter to people affected by interventions to bridge research, evidence synthesis, ...