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| ID | Type | Description | Link |
|---|---|---|---|
| UM1TR004772 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome: Feasibility | Our primary outcome will be feasibility, assessed by the proportion of patients who receive the intervention. | Immediately after intervention delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Process Outcome: Enrollment Rate | Description: As measured by participant enrollment in REDCap. | Immediately after intervention delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Preliminary Efficacy: Communication Assessment Tool (CAT) | 15-item patient-reported communication tool, with minor context-specific adaptations | Immediately after intervention delivery |
| Secondary preliminary efficacy: Serious Illness Experience |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine H. Saunders, PhD, MPH | Contact | 603-653-3436 | Catherine.Hylas.Saunders@dartmouth.edu | |
| Anne E Dade, MPP | Contact | anne.e.dade@dartmouth.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock | Lebanon | New Hampshire | 03756-1000 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39446854 | Background | 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. | |
| 35260261 | 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. |
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We will de-identified quantitative open pilot data available.
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.
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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
| Immediately after intervention delivery |