- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05952999
Analysis of the Virtual Acute Care at Home Experience (HaH)
March 13, 2026 updated by: Colleen J Klein, OSF Healthcare System
Examining the Intervention Effectiveness of Hospital at Home for Improving Health Outcomes and Experiences for Patients, Clinicians, and Caregivers
The purpose of this study is to examine the implementation, intervention effectiveness, and dissemination of a digital acute care delivery model for improving selected health outcomes in the Hospital at Home population.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
The investigators will conduct a mixed-methods quasi-experimental research study that will explore the effectiveness of the Hospital at home programs using qualitative interviews and quantitative data as a means to also conduct a process evaluation related to the implementation and efficacy of Hospital at Home programs.
The purpose of this pragmatic study is to inform scalability beyond the initial site for implementation within a large healthcare system with a diverse patient population located in various communities, including rural and urban locations.
Study Type
Observational
Enrollment (Estimated)
9654
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Peoria, Illinois, United States, 61602
- OSF Healthcare
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of individuals who are receiving care in the hospital at home program and those who are hospitalized but choose to receive hospital care in the home setting after a short period in the hospital.
All those enrolled in the Hospital at Home Program will be strategically identified and used as the population for the quantitative and qualitative portions of the study.
Description
Inclusion Criteria:
- Patients 18 years and older who are admitted into the Hospital at Home program after presenting to the emergency department or who are inpatients that can be cared at home for hospital level needs
- Patients meeting the hospital's criteria for admission by diagnosis type (e.g., heart failure, respiratory infections and inflammations, renal failure, diabetes, pneumonia, bronchitis, chronic obstructive pulmonary disease, fever and inflammatory conditions, viral illnesses, other disorders of the nervous system). Diagnoses are determined by clinicians not researchers.
- Patients will need to reside within 30 minutes' drive time from the hospital
Patient caregiver inclusion criteria: (not required for patient participation):
- Age >= 18 years old
- as capacity to consent to study
Clinician or stakeholder inclusion criteria:
- Any member of the home hospital clinical team (a healthcare professional who providing care or equipment for use in the home) who will be participating in delivery of healthcare services,
- Any member of the hospital care teams, including the screening and recruitment of patients for the home hospital intervention and/or providing care to patients that enroll in the intervention that is provided
- Any member of the leadership team who are involved in the operational aspects of program delivery
Exclusion Criteria:
- Need for long-term facility level care or current residence in a facility of this type
- No one will be excluded on the basis of sex or race
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hospital at Home Care
The population for this study includes adult patients who are acutely ill and presenting to the emergency room, and are discharged to their home for hospital-level care in the home setting.
The patients in this cohort may also include those who are discharged from the hospital early, but receive hospital-level care in the home setting.
|
Patients will need to meet screening and inclusion criteria at time of enrollment.
As a pragmatic study, researchers will not determine criteria or management of care aspects for patients.
Other Names:
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Traditional Hospital Care
The population for this study includes adult patients who are acutely ill and presenting to the emergency room who elect not to be discharged, choose to be cared for in the hospital setting.
|
Patients will be cared for in the inpatient setting for management of diseases that meet screening and inclusion criteria at time of enrollment for hospital at home.
As a pragmatic study, researchers will not determine criteria or management of care aspects for patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite of all-cause mortality for patients admitted to digital hospital
Time Frame: Up to 30 days, (date of death from any cause, whichever came first, assessed up to 30 days)
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Total number of deaths over total number of patients admitted to the digital hospital.
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Up to 30 days, (date of death from any cause, whichever came first, assessed up to 30 days)
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30-day readmission rate
Time Frame: Up to 30 days (date of readmission from any cause, whichever came first, assessed up to 30 days)
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Number of 30-day readmissions as defined by Organization using preset criteria
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Up to 30 days (date of readmission from any cause, whichever came first, assessed up to 30 days)
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Patient Satisfaction at discharge
Time Frame: up to 1 week
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1-item measure: I would recommend this [insert program name] to others, assessed at discharge name] to others.
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up to 1 week
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Patient Perception of Digital Care at discharge
Time Frame: up to 1 week
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Results of Digital Care - Likert Scale (very satisfied to very dissatisfied)
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up to 1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Escalations (for management and treatment of early decompensation)
Time Frame: up to 2 weeks
|
percentage of patients escalated over total hospital digital encounters
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up to 2 weeks
|
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Unplanned readmission within 30-days of discharge
Time Frame: up to 30 days
|
Number of 30-day readmissions over total number of discharges
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up to 30 days
|
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Length of Stay
Time Frame: assessed up to 2 weeks
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Day of admission to day of discharge, assessed up to 2 months
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assessed up to 2 weeks
|
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Number of participants with Hospital Acquired Infections
Time Frame: assessed up to 1 week
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Number of hospital acquired infections reported (CAUTI, CLABSI, etc.)
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assessed up to 1 week
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with discharge disposition at time of discharge as one other than home
Time Frame: assessed up to 8 weeks
|
Exploratory - discharge disposition other than patient's home
|
assessed up to 8 weeks
|
|
Qualitative interviews
Time Frame: through study completion, an average of 2 years
|
Interviews with patients, caregivers, and hospital and digital health clinicians, workers, ancillary services
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through study completion, an average of 2 years
|
|
Number of readmissions between discharge and during next 6 months.
Time Frame: Up to 6 months (Re-admission from any cause, assessed up to 6 months)
|
Exploratory
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Up to 6 months (Re-admission from any cause, assessed up to 6 months)
|
|
Number of Emergency Department visits after discharge for any cause
Time Frame: assessed up to 6 months
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Exploratory
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assessed up to 6 months
|
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Number of visits in home by provider, clinician, and worker type
Time Frame: assessed up to 2 months
|
Exploratory
|
assessed up to 2 months
|
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EuroQol-5D-5L
Time Frame: up to 2 months, assessed twice in this period
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5 items self-reported and visual analogue scale, 0-100, where 100 is the best imaginable health today
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up to 2 months, assessed twice in this period
|
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Program Implementation and Evaluation Measure
Time Frame: at baseline and 1-year following implementation
|
15-item measure to assess health care professionals' perceptions of digital care, measured using a Likert scale of 1 to 5, with 1= Not at all, 2=Slightly, 3=Moderately, 4=Very Much, and 5= Entirely.
Includes three open-ended questions
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at baseline and 1-year following implementation
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Montgomery caregiver burden inventory measure
Time Frame: at approximately 48 hours following admission and at 31-days post-discharge
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11-items to assess objective, relationship, and stress for caregivers.
A 5-point response set ranging from 1 (not at all) to 5 (a great deal)
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at approximately 48 hours following admission and at 31-days post-discharge
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|
Clinical Sustainability Assessment Tool
Time Frame: at baseline and 1-year following implementation
|
Exploratory - measures organizational and contextual factors for sustainability of a project or initiative.
Uses a 7-point Likert scale where 1= to little or no extent to 7=to a great extent.
Also includes response option of N/A - not able to answer.
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at baseline and 1-year following implementation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Colleen Klein, PhD, APRN, OSF Healthcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008.
- Cooling M, Klein CJ, Pierce LM, Delinski N, Lotz A, Vozenilek JA. Access to Care: End-to-End Digital Response for COVID-19 Care Delivery. J Nurse Pract. 2022 Feb;18(2):232-235. doi: 10.1016/j.nurpra.2021.09.011. Epub 2021 Sep 25.
- Federman AD, Soones T, DeCherrie LV, Leff B, Siu AL. Association of a Bundled Hospital-at-Home and 30-Day Postacute Transitional Care Program With Clinical Outcomes and Patient Experiences. JAMA Intern Med. 2018 Aug 1;178(8):1033-1040. doi: 10.1001/jamainternmed.2018.2562.
- Shelton RC, Chambers DA, Glasgow RE. An Extension of RE-AIM to Enhance Sustainability: Addressing Dynamic Context and Promoting Health Equity Over Time. Front Public Health. 2020 May 12;8:134. doi: 10.3389/fpubh.2020.00134. eCollection 2020.
- Savundranayagam MY, Montgomery RJ, Kosloski K. A dimensional analysis of caregiver burden among spouses and adult children. Gerontologist. 2011 Jun;51(3):321-31. doi: 10.1093/geront/gnq102. Epub 2010 Dec 6.
- Arsenault-Lapierre G, Henein M, Gaid D, Le Berre M, Gore G, Vedel I. Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Jun 1;4(6):e2111568. doi: 10.1001/jamanetworkopen.2021.11568.
- Brody AA, Arbaje AI, DeCherrie LV, Federman AD, Leff B, Siu AL. Starting Up a Hospital at Home Program: Facilitators and Barriers to Implementation. J Am Geriatr Soc. 2019 Mar;67(3):588-595. doi: 10.1111/jgs.15782. Epub 2019 Feb 8.
- Chua CMS, Ko SQ, Lai YF, Lim YW, Shorey S. Perceptions of Hospital-at-Home Among Stakeholders: a Meta-synthesis. J Gen Intern Med. 2022 Feb;37(3):637-650. doi: 10.1007/s11606-021-07065-0. Epub 2021 Aug 6.
- Dismore LL, Echevarria C, van Wersch A, Gibson J, Bourke S. What are the positive drivers and potential barriers to implementation of hospital at home selected by low-risk DECAF score in the UK: a qualitative study embedded within a randomised controlled trial. BMJ Open. 2019 Apr 4;9(4):e026609. doi: 10.1136/bmjopen-2018-026609.
- 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.
- Dalstrom MD, Klein CJ, Rothrock-Magana M, Cooling M. Patient-Centered Care: A Qualitative Analysis of Patient and Caregiver Experiences in a Hospital at Home Program. J Patient Exp. 2025 Jun 2;12:23743735251347706. doi: 10.1177/23743735251347706. eCollection 2025.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
June 28, 2023
First Submitted That Met QC Criteria
July 11, 2023
First Posted (Actual)
July 19, 2023
Study Record Updates
Last Update Posted (Actual)
March 17, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Immune System Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Glucose Metabolism Disorders
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Body Temperature Changes
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Heart Failure
- Pulmonary Disease, Chronic Obstructive
- Hypertension
- Asthma
- Disease
- Urologic Diseases
- Diabetes Mellitus
- Infections
- Fever
- Bronchitis
Other Study ID Numbers
- 2015255
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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