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Rural patients get Hospital-Level care at home in landmark trial

NCT ID NCT05256303

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving hospital-level care to acutely ill adults in their own homes in rural areas works well. 160 people with various conditions like infections, heart failure, or COPD took part. The goal was to see if this approach could lower costs and help patients recover at home instead of in a hospital.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

160 people

The number who actually took part.

Started

Feb 2022

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patient clinical inclusion criteria: * \>=18 years old * Any infectious process (e.g., pneumonia, diverticulitis, cellulitis, complicated urinary tract infection) * Heart failure exacerbation * Asthma and chronic obstructive pulmonary disease exacerbation * Atrial fibrillation with rapid ventricular response * Diabetes and its complications * Venous thromboembolism * Gout exacerbation * Chronic kidney disease with volume overload * Hypertensive urgency * End of life / desires only medical management Patient environmental inclusion criteria: * Lives in a rural area that can be served by the RHH team. * Has capacity to consent to study OR can assent to study and has proxy who can consent (see subject enrollment, below) * Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him. After 24 hours, this caregiver should be available for as-needed spot checks on the patient. * This criterion may be waived for highly competent patients at the patient and clinician's discretion. Patient caregiver inclusion criteria: (not required for patient participation): * Age \>= 18 years old * Has capacity to consent to study * Lives within 15 minutes travel time. Clinician inclusion criteria: * The rural home hospital clinical team will be identified by the site PI at each study site prior to the start of the study. The site PI will recruit local RNs and/or EMT-Ps, and attending physicians (MD) to deploy and provide rural home hospital care. * Any member of the rural home hospital clinical team (a clinician providing care in the home) who will be participating in research activities, including the screening and recruitment of patients for the rural home hospital intervention and/or providing care to rural patients that enroll in the intervention. Sites without continuous monitoring will make amendments to the above inclusion criteria Exclusion Criteria: * Patient exclusion clinical criteria: * Acute delirium, as determined by the Confusion Assessment Method * Cannot establish peripheral access by any means * Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage (unless part of end of life pathway) * Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control * Cannot independently ambulate to bedside commode, unless home-based aides are available * As deemed by on-call MD, patient likely to require any of the following procedures that have not already occurred: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery (unless these can be coordinated with appropriate facilities during the home hospitalization) * For pneumonia: * Most recent CURB65 \> 3: new confusion, BUN \> 19mg/dL, respiratory rate\>=30/min, systolic blood pressure\<90mmHg, Age\>=65 (\<14% 30-day mortality)15 * Most recent SMRTCO \> 2: systolic blood pressure \< 90mmHg (2pts), multilobar CXR involvement (1pt), respiratory rate \>= 30/min, heart rate \>= 125, new confusion, oxygen saturation \<= 90% (\<10% chance of intensive respiratory or vasopressor support)16 * Absence of clear infiltrate on imaging * Cavitary lesion on imaging * Pulmonary effusion of unknown etiology * O2 saturation \< 90% despite 5L O2 * For heart failure: * Has a left ventricular assist device * GWTG-HF17 (\>10% in-hospital mortality) or ADHERE18 (high risk or intermediate risk 1)\* * Severe pulmonary hypertension * For complicated urinary tract infection: * Absence of pyuria * Most recent qSOFA \> 1 (SBP≤100 mmHg, RR≥22, GCS\<15 \[any AMS\]) (if sepsis, \>10% mortality)19 * For other infection * Most recent qSOFA \> 1 (SBP≤100 mmHg, RR≥22, GCS\<15 \[any AMS\]) (if sepsis, \>10% mortality)19 * For COPD * BAP-65 score \> 3 (BUN\>25, altered mental status, HR\>109, age\>65) (\<13% chance in-hospital mortality): exercise caution * For asthma o Peak expiratory flow \< 50% of normal: exercise caution * For diabetes and its complications o Requires IV insulin * For hypertensive urgency * Systolic blood pressure \> 190 mmHg * Evidence of end-organ damage; for example, acute kidney injury, focal neurologic deficits, myocardial infarction * For atrial fibrillation with rapid ventricular response * Likely to require cardioversion * New atrial fibrillation with rapid ventricular response * Unstable blood pressure, respiratory rate, or oxygenation * Despite IV beta and/or calcium channel blockade in the emergency department, HR remains \> 125 and SBP remains different than baseline * Less than 1 hour of time has elapsed with HR \< 125 and SBP similar or higher than baseline * Home hospital census is full * GWTG-HF: AHA Get with the Guidelines: SBP, BUN, Na, Age, HR, Black race, COPD ADHERE: Acute decompensated heart failure national registry: BUN, creatinine, SBP Patient environmental exclusion criteria: * Undomiciled * No working heat (October-April), no working air conditioning if forecast \> 80°F (June-September), or no running water * On methadone requiring daily pickup of medication * In police custody * Resides in facility that provides on-site medical care (e.g., skilled nursing facility) * Domestic violence screen positive Sites without continuous monitoring will make amendments to the above exclusion criteria

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Appalachian Regional Healthcare, Inc.

    Hazard, Kentucky, 41701, United States

  • Blessing Health System

    Quincy, Illinois, 62301, United States

  • Wetaskiwin Hospital and Care Centre

    Wetaskiwin, Alberta, T9A 3N3, Canada

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