Clinical trial NCT05952999: Analysis of the Virtual Acute Care at Home Experience
Official title: Examining the Intervention Effectiveness of Hospital at Home for Improving Health Outcomes and Experiences for Patients, Clinicians, and Caregivers
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Conditions
Infections
Heart Failure
Renal and Urinary Disorders
Diabetes
Hypertension
Fever
Bronchitis
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Keywords: home hospital
hospital at home
hospital in the home
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 9654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of all-cause mortality for patients admitted to digital hospital
timeFrame: Up to 30 days, (date of death from any cause, whichever came first, assessed up to 30 days)
measure: 30-day readmission rate
timeFrame: Up to 30 days (date of readmission from any cause, whichever came first, assessed up to 30 days)
measure: Patient Satisfaction at discharge
timeFrame: up to 1 week
measure: Patient Perception of Digital Care at discharge
timeFrame: up to 1 week
Secondary outcomes:
measure: Escalations (for management and treatment of early decompensation)
timeFrame: up to 2 weeks
measure: Unplanned readmission within 30-days of discharge
timeFrame: up to 30 days
measure: Length of Stay
timeFrame: assessed up to 2 weeks
measure: Number of participants with Hospital Acquired Infections
timeFrame: assessed up to 1 week
Other outcomes:
measure: Number of participants with discharge disposition at time of discharge as one other than home
timeFrame: assessed up to 8 weeks
measure: Qualitative interviews
timeFrame: through study completion, an average of 2 years
measure: Number of readmissions between discharge and during next 6 months.
timeFrame: Up to 6 months (Re-admission from any cause, assessed up to 6 months)
measure: Number of Emergency Department visits after discharge for any cause
timeFrame: assessed up to 6 months
measure: Number of visits in home by provider, clinician, and worker type
timeFrame: assessed up to 2 months
measure: EuroQol-5D-5L
timeFrame: up to 2 months, assessed twice in this period
measure: Program Implementation and Evaluation Measure
timeFrame: at baseline and 1-year following implementation
measure: Montgomery caregiver burden inventory measure
timeFrame: at approximately 48 hours following admission and at 31-days post-discharge
measure: Clinical Sustainability Assessment Tool
timeFrame: at baseline and 1-year following implementation
Locations:
city: Peoria
country: United States
facility: OSF HealthCare
state: Illinois
Study officials:
affiliation: OSF HealthCare
name: Colleen Klein, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.