The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute HospitalizationNCT05212077
Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial
A study testing Advanced Care at Home (ACH) and Traditional Brick-and-Mortar Hospitalization in people with The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization, run by Mayo Clinic at 4 sites in United States.
Trial summary
The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization
- What is being tested?
- Advanced Care at Home (ACH) and Traditional Brick-and-Mortar Hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Feb 2022to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients, 18 years of age and older.
- Present to one of the participating hospitals.
- Have a chief complaint of one of the target diagnoses.
- Are within a certain geographical area (based on zip codes).
- Have a health insurance plan that covers ACH services.
- Have the capacity to consent or could assent with the consent of a health care proxy who is physically present.
Who cannot join
- The patient is not suitable for ACH or inpatient hospital care based on:
- being a nursing home patient;
- on or requiring dialysis;
- positive for COVID-19;
- having discharge order;
- requiring intensive care unit (ICU) level of care;
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- history of drug abuse.
- Patients will also need to meet the clinical stability criteria.
- Do not have the capacity to consent or assent with the assistance of a health care proxy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mayo Clinic Health System
Eau Claire, Wisconsin, 54703
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.
- Being tested
- Advanced Care at Home (ACH), Traditional Brick-and-Mortar Hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Care at Home (ACH)Other
Inpatient hospitalization offered in the home setting.
Traditional Brick-and-Mortar HospitalizationOther
Inpatient hospitalization offered in the hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Care at Home (ACH) | Experimental | Patients will receive inpatient hospitalization at home. Receives: Other: Advanced Care at Home (ACH) |
| Traditional Inpatient (Brick-and-Mortar) Hospital Care | Active comparator | Patients will receive inpatient hospitalization at the hospital. Receives: Other: Traditional Brick-and-Mortar Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is a composite outcome of all-cause mortality
The rate of death
Measured: 30 days post-discharge
30-day readmission.
readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge.
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start15 Feb 2022
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute HospitalizationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoxi Yao, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212077
- Sponsor's protocol ID
- 21-005335
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao X, Paulson M, Maniaci MJ, Dunn AN, Nelson CR, Behnken EM, Hart MS, Sangaralingham LR, Inselman SA, Lampman MA, Dunlay SM, Dowdy SC, Habermann EB. Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial. Trials. 2022 Jun 16;23(1):503. doi: 10.1186/s13063-022-06430-6.
PubMed 35710450
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05212077
- Acronym / sponsor ID
- 21-005335
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 27 Jan 2022 (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 purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Care at Home (ACH) | Experimental | Other: Advanced Care at Home (ACH)Patients will receive inpatient hospitalization at home. |
| Traditional Inpatient (Brick-and-Mortar) Hospital Care | Active comparator | Other: Traditional Brick-and-Mortar HospitalizationPatients will receive inpatient hospitalization at the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, 18 years of age and older.
- Present to one of the participating hospitals.
- Have a chief complaint of one of the target diagnoses.
- Are within a certain geographical area (based on zip codes).
- Have a health insurance plan that covers ACH services.
Key exclusion criteria (9 listed)
- The patient is not suitable for ACH or inpatient hospital care based on:
- Patients will also need to meet the clinical stability criteria.
- Do not have the capacity to consent or assent with the assistance of a health care proxy.
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 |
|---|---|---|
| Advanced Care at Home (ACH)Inpatient hospitalization offered in the home setting. | Other | Advanced Care at Home (ACH) |
| Traditional Brick-and-Mortar HospitalizationInpatient hospitalization offered in the hospital setting. | Other | Traditional Inpatient (Brick-and-Mortar) Hospital Care |
Primary outcome
The primary outcome is a composite outcome of all-cause mortality
Time frame: 30 days post-discharge
The rate of death
30-day readmission.
Time frame: 30 days post-discharge
readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge.
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 35710450Yao X, Paulson M, Maniaci MJ, Dunn AN, Nelson CR, Behnken EM, Hart MS, Sangaralingham LR, Inselman SA, Lampman MA, Dunlay SM, Dowdy SC, Habermann EB. Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial. Trials. 2022 Jun 16;23(1):503. doi: 10.1186/s13063-022-06430-6.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Care at Home (ACH) and Traditional Brick-and-Mortar Hospitalization in people with The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization, run by Mayo Clinic at 4 sites 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is a composite outcome of all-cause mortality (time frame: 30 days post-discharge). The study lists 2 primary outcomes in all. 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 NCT05212077, which also lists 1 linked publication.
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 13 Mar 2024.