DementiaI-HTCNCT07889830
Inpatient Hospice Transitions Checklist
A study testing I-HTC in people with Dementia, run by New York University at 1 site in United States.
Trial summary
This is an NIH Stage IB single-arm feasibility study will adapt and test the Inpatient Hospice Transitions Checklist (I-HTC), an Epic-embedded intervention supporting hospice eligibility assessment and clinician-surrogate communication for hospitalized persons living with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- I-HTC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicians:
- Physicians, nurse practitioners, physician assistants, nurses, or social workers practicing in acute care
- Participate in goals-of-care, advance care planning (ACP), hospice, or care transition discussions for hospitalized adults with dementia
- Able to complete study activities in English
- Use the EPIC electronic health record (EHR) for clinical documentation and patient care
- Surrogates:
Show all 17Show fewer
- Adults aged ≥18 years
- Identified as the legally authorized representative (LAR), healthcare proxy, or next of kin
- Participate in goals-of-care, ACP, or hospice-related discussions during hospitalization
- Able to complete study communication in English
- Persons Living with Dementia (PLWD):
- Adults aged ≥60 years admitted to an acute care inpatient service
- Lack decisional capacity
- Have a documented dementia diagnosis in the EHR
- Identified through the NYU Dementia EPIC Registry from the ED-LEAD trial
- Have a "No" response to the Mandatory Surprise Question: "Would you be surprised if this person were to die within the next 6 months?"
- Have clinical circumstances prompting goals-of-care or hospice-related discussions
Who cannot join
- Clinicians:
- Do not routinely participate in ACP, hospice, or care transition discussions
- Decline or do not complete required study training
- Share responsibility for a patient encounter with an enrolled senior clinician
- Surrogates:
- Not the primary decision-maker for the PLWD
- LAR cannot be identified or contacted to obtain informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
NYU Langone Health
New York, New York, 10016
Komal P Murali, PhD, RN, ACNP-BC, 2672055741, kp47@nyu.edu; komal.murali@nyulangone.org
About this study
Official title: Feasibility and Adaptation of a Hospice Transitions Checklist for Hospitalized Persons With Dementia
This is an NIH Stage IB single-arm feasibility study will adapt and test the Inpatient Hospice Transitions Checklist (I-HTC), an Epic-embedded intervention supporting hospice eligibility assessment and clinician-surrogate communication for hospitalized persons living with dementia.
Read the detailed description
This NIH Stage IB study will develop, adapt, and pilot test the Inpatient Hospice Transitions Checklist (I-HTC), an Epic-embedded intervention supporting hospice eligibility assessment and clinician-surrogate communication for hospitalized persons living with dementia aged 60 years and older at NYU Langone Health. The intervention includes a hospice eligibility guide, a structured communication checklist, and a clinician frequently asked questions guide. Three sequential components include surveys with approximately 30 interdisciplinary acute care clinicians to refine intervention content; training and usability testing with approximately 10 clinicians and advance care planning experts to refine the Epic build and workflow integration; and a single-arm feasibility pilot involving approximately 40 clinicians and 100-110 patient-surrogate dyads.
Component 1 will assess clinician preferences, current hospice transition workflows, and communication needs.
Component 2 will assess usability through the System Usability Scale and structured walkthroughs.
Component 3 will evaluate feasibility through checklist use, clinician activation, and EHR documentation fidelity, with additional assessments of usability, workflow integration, hospice enrollment, surrogate understanding of hospice, satisfaction, and communication quality.
- Conditions
- Dementia
- Being tested
- I-HTC
- Keywords
- surrogate decision-making
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-HTCBehavioural
The I-HTC intervention will include 1) hospice eligibility guide, 2) the I-HTC checklist for hospice communication, and 3) a frequently asked questions (FAQ) guide for clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | Experimental | Usual Care Arm: To be used by acute care clinicians with surrogates of eligible hospitalized persons living with dementia Receives: Behavioral: I-HTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the I-HTC Checklist EHR Intervention (Reported by Clinicians)
Frequency and proportion of I-HTC use during eligible encounters, clinician activation (accessing the I-HTC at least once), fidelity of ACP and hospice-related EHR documentation, and integration into clinical workflows.
Measured: Within 1 month of trial completion
Secondary outcomes (5)
Usability of the I-HTC Intervention as Reported by Clinicians
Usability: Clinician-reported ease of use and usability of the I-HTC, assessed using the System Usability Scale.
The SU scale is generally used after the respondent has had an opportunity to use the system being evaluated, but before any debriefing or discussion takes place. Respondents should be asked to record their immediate response to each item, rather than thinking about items for a long time. SUS yields a single number representing a composite measure of the overall usability of the system being studied. Note that scores for individual items are not meaningful on their own. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of SU.
Measured: Within 1 month of intervention delivery to surrogate
Hospice enrollment of the PLWD
Proportion of participating PLWD who enroll in hospice, determined through EHR review.
Measured: Within 1 month of intervention receipt (PLWD-EHR data)
Surrogate understanding of hospice care
(Investigator Initiated) - This brief questionnaire focused on surrogate-reported understanding of hospice services and their role in supporting the person living with dementia. The six-item Hospice Understanding Assessment will measure surrogate decision-makers' self-reported understanding of hospice care following clinician-led discussions. Each item is rated on a 5-point Likert scale, with total scores ranging from 6 to 30. Higher scores indicate greater perceived understanding of hospice eligibility, services, care options, and confidence in decision-making. Mean scores and standard deviations will be calculated, and individual item responses will be examined to identify areas of limited understanding. Scores will be interpreted descriptively, as the assessment does not have established clinical cutoffs.
Measured: within 1 month of intervention receipt (surrogate)
Surrogate satisfaction
Satisfaction with care, assessed using the FAMCARE scale.
The original 20-item FAMCARE scale will assess surrogate decision-makers' satisfaction with care provided to their family member. Each item is rated on a 5-point Likert scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied). Responses will be reverse-coded and summed to generate a total score ranging from 20 to 100, with higher scores indicating greater satisfaction with care. Mean scores, standard deviations, and individual item responses will be examined descriptively to evaluate overall satisfaction and identify areas for improvement in care delivery and communication.
Measured: within 1 month of intervention receipt (surrogate)
Quality of communication as reported by the surrogate after receiving the I-HTC intervention
Quality of communication: Surrogate-reported quality of clinician-surrogate communication, assessed using the Quality of Communication questionnaire.
The Quality of Communication (QOC) Questionnaire, developed by Engelberg et al. (2006), assesses perceived quality of clinician communication using 13 items across two subscales: general communication skills (6 items) and end-of-life communication (7 items). Each item is rated on an 11-point scale ranging from 0 (Worst imaginable) to 10 (Best imaginable). Subscale scores are calculated as the mean of the corresponding item ratings, with higher scores indicating better perceived communication quality.
Measured: within 1 month of intervention receipt (surrogate)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), NYU Langone Health
- Responsible party
- Principal investigator, Komal Patel Murali,, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889830
- Sponsor's protocol ID
- s26-00690
- Other IDs
- U54AG093230
- Acronym
- I-HTC
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified participant data will be shared with the ASCENT consortium but clinician data is not able to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Adaptation of a Hospice Transitions Checklist for Hospitalized Persons With Dementia
- ClinicalTrials.gov ID
- NCT07889830
- Acronym / sponsor ID
- I-HTC / s26-00690
- Conditions
- Dementia
- Keywords
- surrogate decision-making
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), NYU Langone Health
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Oct 2026 (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.
This is an NIH Stage IB single-arm feasibility study will adapt and test the Inpatient Hospice Transitions Checklist (I-HTC), an Epic-embedded intervention supporting hospice eligibility assessment and clinician-surrogate communication for hospitalized persons living with dementia.
Detailed description
This NIH Stage IB study will develop, adapt, and pilot test the Inpatient Hospice Transitions Checklist (I-HTC), an Epic-embedded intervention supporting hospice eligibility assessment and clinician-surrogate communication for hospitalized persons living with dementia aged 60 years and older at NYU Langone Health. The intervention includes a hospice eligibility guide, a structured communication checklist, and a clinician frequently asked questions guide. Three sequential components include surveys with approximately 30 interdisciplinary acute care clinicians to refine intervention content; training and usability testing with approximately 10 clinicians and advance care planning experts to refine the Epic build and workflow integration; and a single-arm feasibility pilot involving approximately 40 clinicians and 100-110 patient-surrogate dyads.
Component 1 will assess clinician preferences, current hospice transition workflows, and communication needs.
Component 2 will assess usability through the System Usability Scale and structured walkthroughs.
Component 3 will evaluate feasibility through checklist use, clinician activation, and EHR documentation fidelity, with additional assessments of usability, workflow integration, hospice enrollment, surrogate understanding of hospice, satisfaction, and communication quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | Experimental | Behavioral: I-HTCUsual Care Arm: To be used by acute care clinicians with surrogates of eligible hospitalized persons living with dementia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Physicians, nurse practitioners, physician assistants, nurses, or social workers practicing in acute care
- Participate in goals-of-care, advance care planning (ACP), hospice, or care transition discussions for hospitalized adults with dementia
- Able to complete study activities in English
- Use the EPIC electronic health record (EHR) for clinical documentation and patient care
- Adults aged ≥18 years
Key exclusion criteria (7 listed)
- Do not routinely participate in ACP, hospice, or care transition discussions
- Decline or do not complete required study training
- Share responsibility for a patient encounter with an enrolled senior clinician
- Not the primary decision-maker for the PLWD
- LAR cannot be identified or contacted to obtain informed 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 |
|---|---|---|
| I-HTCThe I-HTC intervention will include 1) hospice eligibility guide, 2) the I-HTC checklist for hospice communication, and 3) a frequently asked questions (FAQ) guide for clinicians. | Behavioural | Usual Care Arm |
Primary outcome
Feasibility of the I-HTC Checklist EHR Intervention (Reported by Clinicians)
Time frame: Within 1 month of trial completion
Frequency and proportion of I-HTC use during eligible encounters, clinician activation (accessing the I-HTC at least once), fidelity of ACP and hospice-related EHR documentation, and integration into clinical workflows.
5 secondary outcomes
Usability of the I-HTC Intervention as Reported by Clinicians
Time frame: Within 1 month of intervention delivery to surrogate
Hospice enrollment of the PLWD
Time frame: Within 1 month of intervention receipt (PLWD-EHR data)
Surrogate understanding of hospice care
Time frame: within 1 month of intervention receipt (surrogate)
Surrogate satisfaction
Time frame: within 1 month of intervention receipt (surrogate)
Quality of communication as reported by the surrogate after receiving the I-HTC intervention
Time frame: within 1 month of intervention receipt (surrogate)
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 2 Nov 2026.
- Individual participant dataSharing planned: No. De-identified participant data will be shared with the ASCENT consortium but clinician data is not able to be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-HTC in people with Dementia, run by New York University 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 17 inclusion and 7 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 2 Nov 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 Komal P Murali, PhD, RN, ACNP-BC (267-205-5741, kp47@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the I-HTC Checklist EHR Intervention (Reported by Clinicians) (time frame: Within 1 month of trial completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.