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

NCT07127666 | Not Yet Recruiting

• 2 other identifiers: STUDY02002855UM1TR004772
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Complexity

Keywords

clinical agenda-setting; pediatric inpatient care

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Feasibility

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

  Immediately after intervention delivery

Secondary Outcomes (1)

• Primary Process Outcome: Enrollment Rate

  Immediately after intervention delivery

Other Outcomes (2)

• Primary Preliminary Efficacy: Communication Assessment Tool (CAT)

  Immediately after intervention delivery

• Secondary preliminary efficacy: Serious Illness Experience

  Immediately after intervention delivery

Study Arms (1)

Treatment (Implements Structured Agenda-Setting Intervention)

EXPERIMENTAL

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

Other: Structured Agenda-Setting Tool

Interventions

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.

Treatment (Implements Structured Agenda-Setting Intervention)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Dartmouth Hitchcock

Lebanon, New Hampshire, 03756-1000, United States

Location

Related Publications (2)

• 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.

  PMID: 39446854 BACKGROUND

• 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.

  PMID: 35260261 BACKGROUND

Central Study Contacts

Catherine H. Saunders, PhD, MPH

CONTACT

603-653-3436; Catherine.Hylas.Saunders@dartmouth.edu

Anne E Dade, MPP

CONTACT

anne.e.dade@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of the Healthcare Experience Lab (HEx Lab)

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 17, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study will use standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats, dictionaries, variable names, descriptions, and labels. An XML schema using Data Documenting Initiative standards will also be used for codebooks and other metadata as appropriate. The researchers will share open pilot process and outcomes data in CSV files via openICPSR, which is a self-publishing repository for social, behavioral and health science data and part of the ICPSR.

Locations

US (1)