An interventional study of Structured Agenda-Setting Tool in Medical Complexity, sponsored by Dartmouth-Hitchcock Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Health services research
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.
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.
Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for the pediatric inpatient environment.
Other: 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.
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
Primary Process Outcome: Enrollment Rate
Description: As measured by participant enrollment in REDCap.
Time frame: Immediately after intervention delivery
Primary Preliminary Efficacy: Communication Assessment Tool (CAT)
15-item patient-reported communication tool, with minor context-specific adaptations
Time frame: Immediately after intervention delivery
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
Plan to share: Yes — We will de-identified quantitative open pilot data available.
Supporting information: Study protocol
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center