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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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:
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  • 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.

Komal P Murali, PhD, RN, ACNP-BC contact

267-205-5741

kp47@nyu.edu

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

Other trials in United States

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 groups in NCT07889830
Study groupRoleWhat they receive
Usual Care ArmExperimentalUsual 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.

  1. 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)
  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  1. First posted22 Oct 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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)
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.

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.

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