ASKids! Inpatient Agenda-Setting Study for Hospitalized Children With Medical Complexity

NCT ID: NCT07127666

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-01
• Study Completion Date: 2026-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Medical Complexity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Treatment (Implements Structured Agenda-Setting Intervention)

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

Group Type: EXPERIMENTAL

Structured Agenda-Setting Tool

Intervention Type: 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.

Interventions

Structured Agenda-Setting Tool

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Catherine Hylas Saunders

Principal Investigator of the Healthcare Experience Lab (HEx Lab)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dartmouth Hitchcock

Lebanon, New Hampshire, United States

Countries

United States

Central Contacts

Catherine H. Saunders, PhD, MPH

Role: CONTACT

Catherine.Hylas.Saunders@dartmouth.edu

603-653-3436

Anne E Dade, MPP

Role: CONTACT

anne.e.dade@dartmouth.edu

References

Sierpe A, Yen RW, Stevens G, Van Citters AD, Elwyn G, Saunders CH. Agenda-setting in the clinical encounter: A systematic review protocol. PLoS One. 2024 Oct 24;19(10):e0312613. doi: 10.1371/journal.pone.0312613. eCollection 2024.

Reference Type: BACKGROUND

PMID: 39446854 (View on PubMed)

Saunders CH, Durand MA, Kirkland KB, MacMartin MA, Barnato AE, Elwyn G. Psychometric assessment of the consideRATE questions, a new measure of serious illness experience, with an online simulation study. Patient Educ Couns. 2022 Jul;105(7):2581-2589. doi: 10.1016/j.pec.2022.01.002. Epub 2022 Jan 22.

Reference Type: BACKGROUND

PMID: 35260261 (View on PubMed)

Other Identifiers

UM1TR004772

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY02002855

Identifier Type: -

Identifier Source: org_study_id