Emergency Department VisitNCT06819852
Acute Hospital Care at Home for People Living With Dementia
A study testing Acute hospital care at home and Standard medical treatment in people with Emergency Department Visit and Home Care Services, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The investigators will perform a parallel-group multicenter randomized controlled trial of a 1-year pre-enrolled acute hospital care at home intervention vs usual care for people living with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Department Visit, Home Care Services, Dementia
- What is being tested?
- Acute hospital care at home and Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2026to 1 Jul 2029
- 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
- Diagnosis of moderate or severe dementia (as ascertained by the Quick Dementia Rating System; QDRS)
- Resides in a private or assisted living residence with or nearby (<15min travel time) to a family caregiver
- Resides within the Mass General Brigham (MGB) home hospital catchment area
- Has had at least 1 hospitalization in the last 12 months.
Who cannot join
- Hospitalized in the last 30 days
- No functioning utilities, such as no working heat (October-April), no running water, or no electricity.
- Resides in skilled nursing facility
- Resides in group home
- Domestic violence screen positive
- In police custody
Show all 14Show fewer
- Family caregiver unable to initiate or maintain communication with care team
- End-stage renal disease on hemodialysis
- On methadone requiring daily pickup of medication
- Active substance use disorder, without functioning treatment plan
- Psychiatric diagnosis that would prohibit successful home hospital care
- Acute delirium without explanation or without the ability to manage at home
- Patients with cancer requiring consistent hospital-based treatments
- Cannot ambulate to bedside commode with assistance present in the home (if different from baseline), unless home-based aides are available
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
Brigham and Women's Hospital
Boston, Massachusetts, 02120
David M Levine, MD, MPH, MA
About this study
Official title: Skipping the Hospital: Acute Hospital Care at Home for People Living With Dementia
The investigators will perform a parallel-group multicenter randomized controlled trial of a 1-year pre-enrolled acute hospital care at home intervention vs usual care for people living with dementia. Patients will be randomized only after eligibility determination and after the family caregiver agrees to enroll; people living with dementia will assent when able. Patients will be allocated in a concealed fashion to the control and intervention groups in randomly selected block sizes of 4 or 6 in 4 strata reflecting their functional status (activities of daily living: 0, 1, 2-3, 4-6). Although family and clinicians cannot be blinded, the investigators will blind the data collectors and assessors.
- Conditions
- Emergency Department Visit, Home Care Services, Dementia
- Being tested
- Acute hospital care at home, Standard medical treatment
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute hospital care at homeOther
Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.
Standard medical treatmentOther
Standard acute and emergency care delivered in a brick-and-mortar hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Acute care at a brick-and-mortar hospital. Receives: Other: Standard medical treatment |
| Acute hospital care at home | Experimental | Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed. Receives: Other: Acute hospital care at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days at home
Sum of the number of days spent at home within the 30-days after an acute care episode
Measured: Discharge to 30-days post discharge, up to 30 days
Secondary outcomes (4)
30-day unplanned readmission or mortality
Percentage of unplanned readmissions or mortality
Measured: Discharge to 30-days post discharge, up to 30 days
Delirium
Percentage of days experiencing delirium while receiving acute care using the short confusion assessment method.
Measured: Date of admission to date of discharge, estimated 5 days
Health-related quality of life
Absolute change of health-related quality of life over the year through the dementia quality of life survey (DEMQOL), or for patients unable to complete the survey, its proxy version (DEMQOL-Proxy).
Measured: From enrollment for the period of one year
Physical activity
Percent of time sedentary as measured by patch monitoring system.
Measured: Date of admission to date of discharge, estimated 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start17 Nov 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Department VisitStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819852
- Sponsor's protocol ID
- 2025P000002
- Other IDs
- R01AG082771-01A1
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skipping the Hospital: Acute Hospital Care at Home for People Living With Dementia
- ClinicalTrials.gov ID
- NCT06819852
- Acronym / sponsor ID
- 2025P000002
- Conditions
- Emergency Department Visit, Home Care Services, Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 11 Feb 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 investigators will perform a parallel-group multicenter randomized controlled trial of a 1-year pre-enrolled acute hospital care at home intervention vs usual care for people living with dementia. Patients will be randomized only after eligibility determination and after the family caregiver agrees to enroll; people living with dementia will assent when able. Patients will be allocated in a concealed fashion to the control and intervention groups in randomly selected block sizes of 4 or 6 in 4 strata reflecting their functional status (activities of daily living: 0, 1, 2-3, 4-6). Although family and clinicians cannot be blinded, the investigators will blind the data collectors and assessors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Standard medical treatmentAcute care at a brick-and-mortar hospital. |
| Acute hospital care at home | Experimental | Other: Acute hospital care at homeHome visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of moderate or severe dementia (as ascertained by the Quick Dementia Rating System; QDRS)
- Resides in a private or assisted living residence with or nearby (<15min travel time) to a family caregiver
- Resides within the Mass General Brigham (MGB) home hospital catchment area
- Has had at least 1 hospitalization in the last 12 months.
Key exclusion criteria (14 listed)
- Hospitalized in the last 30 days
- No functioning utilities, such as no working heat (October-April), no running water, or no electricity.
- Resides in skilled nursing facility
- Resides in group home
- Domestic violence screen positive
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 |
|---|---|---|
| Acute hospital care at homeHome visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed. | Other | Acute hospital care at home |
| Standard medical treatmentStandard acute and emergency care delivered in a brick-and-mortar hospital setting. | Other | Usual care |
Primary outcome
Number of days at home
Time frame: Discharge to 30-days post discharge, up to 30 days
Sum of the number of days spent at home within the 30-days after an acute care episode
4 secondary outcomes
30-day unplanned readmission or mortality
Time frame: Discharge to 30-days post discharge, up to 30 days
Delirium
Time frame: Date of admission to date of discharge, estimated 5 days
Health-related quality of life
Time frame: From enrollment for the period of one year
Physical activity
Time frame: Date of admission to date of discharge, estimated 5 days
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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 Acute hospital care at home and Standard medical treatment in people with Emergency Department Visit and Home Care Services, run by Brigham and Women's Hospital 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 4 inclusion and 14 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 16 Oct 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 David M Levine, MD, MPH, MA (617-732-7063, dmlevine@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days at home (time frame: Discharge to 30-days post discharge, up to 30 days). 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 16 Oct 2026.