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NCT Number: NCT07127666

ASKids! Inpatient Agenda-Setting Study for Hospitalized 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. We pilot a co-designed structured agenda-setting intervention (SAS) for multi-family meetings about children with medical complexity. Our open pilot will evaluate the feasibility and acceptability of using the SAS during routine multidisciplinary family meetings (MFM) at Dartmouth Hitchcock Medical Center. By doing an open pilot, researchers will learn if the agenda-setting instrument and implementation process are feasible and acceptable to patients, their care partner and their clinicians.

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Key information

Conditions

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock

Lebanon, New Hampshire, 03756-1000, United States

About this study

In this open pilot, the researchers will adapt and administer a novel structured agenda-setting tool (SAS) in the inpatient pediatric environment. The researchers will determine if their procedures for screening eligible participants, administering the intervention, and administering outcome and other questionnaires are appropriate. Learnings from the open pilot will feed forward into procedures in applications for larger trials of the intervention.

This study only has one arm, the intervention arm. The intervention, the co-adapted SAS, will be administered to all enrolled participants.

Future Directions: This open pilot will provide preliminary data for potential future larger trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric Inpatients: Children aged 7-17 years
  • Can communicate in English
  • Able to provide verbal assent, with consent from their care partner
  • 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 Care Partners: - Adults aged 18≥ years
  • Can communicate in English
  • Able to provide 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

  • For pediatric inpatients, children < aged 7
  • For care partners, children aged <18 years
  • Cannot communicate in English
  • For pediatric inpatients, unable to provide verbal assent
  • For care partners, unable to provide consent
  • Prisoners

Treatment and study plan

Structured Agenda-Setting Tool

Other

We are testing a novel clinical visit agenda-setting intervention developed through participatory research methods for the pediatric inpatient environment. This structured agenda-setting (SAS) intervention will be co-designed to include structured discussion topic areas with the option for patients (when appropriate) and their care partners to consider and indicate their priority topic areas and take notes before, during, and after a clinical visit.

Primary outcomes

  1. Primary Outcome: Feasibility

    Time frame: Immediately after intervention delivery

    Our primary outcome will be feasibility, assessed by the proportion of patients who receive the intervention.

Secondary outcomes

  1. Primary Process Outcome: Enrollment Rate

    Time frame: Immediately after intervention delivery

    Description: As measured by participant enrollment in REDCap.

Other outcomes

  1. Primary Preliminary Efficacy: Communication Assessment Tool (CAT)

    Time frame: Immediately after intervention delivery

    15-item patient-reported communication tool, with minor context-specific adaptations

  2. Secondary preliminary efficacy: Serious Illness Experience

    Time frame: Immediately after intervention delivery

    Serious illness experience measured by the consideRATE questions; a validated 8-item, plain language (2nd grade) patient-reported experience measure (PREM) with Likert-like response options for patients, and care partners

Study contacts

Contact information is provided by the study sponsor or research team.

Anne E Dade, MPP

CONTACT

[email protected]

Catherine H. Saunders, PhD, MPH

CONTACT

[email protected]

603-653-3436

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Centering Children and Care Partners in Complex Pediatric Hospital Stays: Evaluation of a Structured Inpatient Agenda-setting Intervention for Multidisciplinary Family Meetings

Acronym: ASKids

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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