Agenda-Setting Tool for Children with Medical Complexity

(ASKids Trial)

Overseen By Anne E Dade, MPP

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Under 7, Non-English, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Structured Agenda-Setting Tool, to assist in setting agendas during family meetings for hospitalized children with complex medical needs. The goal is to determine if this tool is easy to use and beneficial for families and healthcare teams. Testing occurs with families at Dartmouth Hitchcock Medical Center. Children aged 7-17 who have been hospitalized for at least four days and can speak English may qualify. As an unphased trial, this study allows families to contribute to enhancing communication tools in healthcare settings.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this agenda-setting tool is safe for children with medical complexity?

Research has shown that the Structured Agenda-Setting Tool (SAS) aims to make hospital stays less stressful and more effective for families. This tool ensures clear understanding among everyone involved in a child's care. As SAS is not a medication, it lacks the physical side effects associated with drugs.

The purpose of SAS is to enhance communication between families and medical teams during hospital meetings, leading to better understanding and coordination without the risks of new medications. Studies on similar tools have demonstrated that families and medical staff generally find them helpful and not harmful. While SAS presents no known physical safety concerns, its success relies on effective use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Agenda-Setting Tool for children with medical complexity because it introduces a structured approach to organizing clinical visits, tailored specifically for the pediatric inpatient setting. Unlike typical care, which often lacks a formalized method for prioritizing patient needs during visits, this tool helps streamline communication and ensure that all critical issues are addressed systematically. This method aims to improve coordination and satisfaction for both families and healthcare providers, potentially enhancing the overall quality of care for these complex cases.

What evidence suggests that the Structured Agenda-Setting Tool is effective for children with medical complexity?

Research shows that structured agenda-setting tools can enhance communication between families and healthcare teams for children with complex medical needs. In this trial, participants will use a structured clinical visit agenda-setting intervention tailored for the pediatric inpatient environment. This tool ensures that important topics are addressed during meetings, improving communication. While specific data on this tool's effectiveness is limited, similar methods in organized care planning have demonstrated positive outcomes. These methods have improved care coordination and increased satisfaction for both families and healthcare providers. The goal is to ensure mutual understanding, leading to better care for the child. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for hospitalized children with complex medical conditions. To participate, they must be scheduled for a routine multidisciplinary family meeting at Dartmouth Hitchcock Medical Center.

Inclusion Criteria

Dartmouth Hitchcock Medical Center pediatric patient who currently or has recently (within the last 3 months) been hospitalized with a length of stay of 4≥ days

I am 18 or older, speak English, and can give verbal consent.

Care partners of Dartmouth Hitchcock Medical Center pediatric patients who are currently or have recently (within the last 3 months) been hospitalized with a length of stay of 4≥ days

Exclusion Criteria

My child is younger than 7 years old.

For care partners, unable to provide consent

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Intervention

Implementation of a structured clinical visit agenda-setting (SAS) intervention customized for the pediatric inpatient environment

Follow-up

Participants are monitored for feasibility and acceptability of the intervention immediately after delivery

What Are the Treatments Tested in This Trial?

Interventions

• Structured Agenda-Setting Tool

Trial Overview The study tests a Structured Agenda-Setting Tool designed to improve communication in family meetings about the child's care. It aims to see if this tool is practical and well-received by patients, families, and clinicians.

How Is the Trial Designed?

Group I: Treatment (Implements Structured Agenda-Setting Intervention) Experimental Treatment 1 Intervention

The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for the pediatric inpatient environment.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07127666

NCT07127666 | ASKids! Inpatient Agenda-Setting Study ... We pilot a co-designed structured agenda-setting intervention (SAS) for multi-family meetings about children with medical complexity. Our open pilot will ...

2. patlynk.com patlynk.com/trial/NCT07127666

ASKids | Agenda-setting Tool for Multidisciplinary Meetings ... The study will look at how well the tool works by evaluating how it is used and whether it helps improve communication between families and healthcare teams.

3. withpower.com withpower.com/trial/phase-medical-complexity-4-2026-2c815

Agenda-Setting Tool for Children with Medical Complexity ... The goal of this open pilot is to co-design and test a clinical agenda-setting intervention in the inpatient pediatric environment.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10028546/

Effectiveness of Structured Care Coordination for Children ... Effectiveness of structured care coordination for children with medical complexity: The Complex Care for Kids Ontario (CCKO) Randomized Clinical Trial

5. lpfch.org lpfch.org/wp-content/uploads/2022/03/Research-Agenda-Principles-of-Care.pdf

Research Agenda for Implementation of Principles of Care ... 1,2 Children and youth with special health care needs (CYSHCN) have a range of medical, educational, and support service needs to achieve optimal health, growth ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36775713/

A Tool to Promote Medication Safety for Children with ... This tool tutorial describes a novel and pragmatic strategy for the development and implementation of medication rounds, a model that promotes medication safety ...