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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Structured Agenda-Setting Tool
Other interventionWe 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
Trial outcomes
Primary outcomes
Primary Outcome: Feasibility
Our primary outcome will be feasibility, assessed by the proportion of patients who receive the intervention.
Secondary outcomes
Primary Process Outcome: Enrollment Rate
Description: As measured by participant enrollment in REDCap.
Other outcomes
Primary Preliminary Efficacy: Communication Assessment Tool (CAT)
15-item patient-reported communication tool, with minor context-specific adaptations
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
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: