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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Structured Agenda-Setting Tool

    Other intervention

    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 groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (Implements Structured Agenda-Setting Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Outcome: Feasibility

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

Time frame
Immediately after intervention delivery

Secondary outcomes

1

Primary Process Outcome: Enrollment Rate

Description: As measured by participant enrollment in REDCap.

Time frame
Immediately after intervention delivery

Other outcomes

1

Primary Preliminary Efficacy: Communication Assessment Tool (CAT)

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

Time frame
Immediately after intervention delivery
2

Secondary preliminary efficacy: Serious Illness Experience

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

Time frame
Immediately after intervention delivery

Sponsors and contacts

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Dartmouth-Hitchcock Medical Center

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: