Medical ComplexityASKidsNCT07127666
ASKids! Inpatient Agenda-Setting Study for Hospitalized Children With Medical Complexity
A study testing Structured Agenda-Setting Tool in people with Medical Complexity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Medical Complexity
- What is being tested?
- Structured Agenda-Setting Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne E Dade, MPP contact
United States1 site
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756-1000
About this study
Official title: Centering Children and Care Partners in Complex Pediatric Hospital Stays: Evaluation of a Structured Inpatient Agenda-setting Intervention for Multidisciplinary Family Meetings
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.
Read the detailed description
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.
- Conditions
- Medical Complexity
- Being tested
- Structured Agenda-Setting Tool
- Keywords
- clinical agenda-setting, pediatric inpatient care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Agenda-Setting ToolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Structured Agenda-Setting Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Feasibility
Our primary outcome will be feasibility, assessed by the proportion of patients who receive the intervention.
Measured: Immediately after intervention delivery
Secondary outcomes (1)
Primary Process Outcome: Enrollment Rate
Description: As measured by participant enrollment in REDCap.
Measured: Immediately after intervention delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Aug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medical ComplexityStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Catherine Hylas Saunders, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127666
- Sponsor's protocol ID
- STUDY02002855
- Other IDs
- UM1TR004772
- Acronym
- ASKids
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will de-identified quantitative open pilot data available.
Publications
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.
PubMed 39446854Saunders 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.
PubMed 35260261
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centering Children and Care Partners in Complex Pediatric Hospital Stays: Evaluation of a Structured Inpatient Agenda-setting Intervention for Multidisciplinary Family Meetings
- ClinicalTrials.gov ID
- NCT07127666
- Acronym / sponsor ID
- ASKids / STUDY02002855
- Conditions
- Medical Complexity
- Keywords
- clinical agenda-setting, pediatric inpatient care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Implements Structured Agenda-Setting Intervention) | Experimental | Other: Structured Agenda-Setting ToolThe study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for the pediatric inpatient environment. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Agenda-Setting ToolWe 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. | Other | Treatment (Implements Structured Agenda-Setting Intervention) |
Primary outcome
Primary Outcome: Feasibility
Time frame: Immediately after intervention delivery
Our primary outcome will be feasibility, assessed by the proportion of patients who receive the intervention.
1 secondary outcome
Primary Process Outcome: Enrollment Rate
Time frame: Immediately after intervention delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 39446854Sierpe 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.
- Background: PubMed 35260261Saunders 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.
- Individual participant dataSharing planned: Yes. We will de-identified quantitative open pilot data available.
Related trials for Medical Complexity
Recruiting
Sibling Caregiver CMC Pilot Study
Children With Medical Complexity (CMC), Siblings
Enrolling by invitation
Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients
Pediatric Medical Complexity Based on PMCA Score of 3
Not yet recruiting
Pilot Trial of a Meaning And Problem-Solving (MAPS) Intervention for Family Caregivers of Children With Medical Complexity
Family Caregivers, Children With Medical Complexity (CMC)
Not yet recruiting
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
Children With Medical Complexity, Respiratory Tract Infections (RTI)
Recruiting
Nurse-led Integrated Home Service to Support Parents in Symptom Management for Children Requiring Respiratory Support
Children With Medical Complexity (CMC), Symptom Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne E Dade, MPP contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Agenda-Setting Tool in people with Medical Complexity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine H. Saunders, PhD, MPH (603-653-3436, Catherine.Hylas.Saunders@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: Feasibility (time frame: Immediately after intervention delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07127666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.