HaH: Analysis of the Virtual Acute Care at Home Experience

Sponsor

OSF Healthcare System (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05952999

Collaborator

(none)

9,654

Enrollment

41.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conditions Infections Heart Failure Renal and Urinary Disorders Diabetes Hypertension Fever Bronchitis Asthma, Chronic Obstructive Pulmonary Disease (COPD)	Other: Digital Care Solution as supportive personalized care Other: Traditional Hospital Level Care

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 Design

Study Type:

Observational

Anticipated Enrollment :

9654 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Examining the Intervention Effectiveness of Hospital at Home for Improving Health Outcomes and Experiences for Patients, Clinicians, and Caregivers

Anticipated Study Start Date :

Jul 15, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	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.	Other: Digital Care Solution as supportive personalized care 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: Traditional Hospital Level Care
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.	Other: Traditional Hospital Level Care 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.

Arm

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.

Other: Digital Care Solution as supportive personalized care

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:

Traditional Hospital Level Care

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.

Other: Traditional Hospital Level Care

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.

Outcome Measures

Primary Outcome Measures

Composite of all-cause mortality for patients admitted to digital hospital [Up to 30 days, (date of death from any cause, whichever came first, assessed up to 30 days)]
Total number of deaths over total number of patients admitted to the digital hospital.
30-day readmission rate [Up to 30 days (date of readmission from any cause, whichever came first, assessed up to 30 days)]
Number of 30-day readmissions as defined by Organization using preset criteria
Patient Satisfaction at discharge [up to 1 week]
1-item measure: I would recommend this [insert program name] to others, assessed at discharge name] to others.
Patient Perception of Digital Care at discharge [up to 1 week]
Results of Digital Care - Likert Scale (very satisfied to very dissatisfied)

Secondary Outcome Measures

Escalations (for management and treatment of early decompensation) [up to 2 weeks]
percentage of patients escalated over total hospital digital encounters
Unplanned readmission within 30-days of discharge [up to 30 days]
Number of 30-day readmissions over total number of discharges
Length of Stay [assessed up to 2 weeks]
Day of admission to day of discharge, assessed up to 2 months
Number of participants with Hospital Acquired Infections [assessed up to 1 week]
Number of hospital acquired infections reported (CAUTI, CLABSI, etc.)

Other Outcome Measures

Number of participants with discharge disposition at time of discharge as one other than home [assessed up to 8 weeks]
Exploratory - discharge disposition other than patient's home
Qualitative interviews [through study completion, an average of 2 years]
Interviews with patients, caregivers, and hospital and digital health clinicians, workers, ancillary services
Number of readmissions between discharge and during next 6 months. [Up to 6 months (Re-admission from any cause, assessed up to 6 months)]
Exploratory
Number of Emergency Department visits after discharge for any cause [assessed up to 6 months]
Exploratory
Number of visits in home by provider, clinician, and worker type [assessed up to 2 months]
Exploratory
EuroQol-5D-5L [up to 2 months, assessed twice in this period]
5 items self-reported and visual analogue scale, 0-100, where 100 is the best imaginable health today
Program Implementation and Evaluation Measure [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
Montgomery caregiver burden inventory measure [at approximately 48 hours following admission and at 31-days post-discharge]
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)
Clinical Sustainability Assessment Tool [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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