Analysis of the Virtual Acute Care at Home Experience

Hypertension Clinical Trial

— HaH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05952999
• Other study ID #: 2015255
• Status: Enrolling by invitation
• Start date: August 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 9654
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma, Chronic Obstructive Pulmonary Disease (COPD)
• Bronchitis
• Conditions
• Diabetes
• Fever
• Heart Failure
• Hypertension
• Infections
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Urologic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	OSF HealthCare	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with discharge disposition at time of discharge as one other than home	Exploratory - discharge disposition other than patient's home	assessed up to 8 weeks
Other	Qualitative interviews	Interviews with patients, caregivers, and hospital and digital health clinicians, workers, ancillary services	through study completion, an average of 2 years
Other	Number of readmissions between discharge and during next 6 months.	Exploratory	Up to 6 months (Re-admission from any cause, assessed up to 6 months)
Other	Number of Emergency Department visits after discharge for any cause	Exploratory	assessed up to 6 months
Other	Number of visits in home by provider, clinician, and worker type	Exploratory	assessed up to 2 months
Other	EuroQol-5D-5L	5 items self-reported and visual analogue scale, 0-100, where 100 is the best imaginable health today	up to 2 months, assessed twice in this period
Other	Program Implementation and Evaluation Measure	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	at baseline and 1-year following implementation
Other	Montgomery caregiver burden inventory measure	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)	at approximately 48 hours following admission and at 31-days post-discharge
Other	Clinical Sustainability Assessment Tool	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.	at baseline and 1-year following implementation
Primary	Composite of all-cause mortality for patients admitted to digital hospital	Total number of deaths over total number of patients admitted to the digital hospital.	Up to 30 days, (date of death from any cause, whichever came first, assessed up to 30 days)
Primary	30-day readmission rate	Number of 30-day readmissions as defined by Organization using preset criteria	Up to 30 days (date of readmission from any cause, whichever came first, assessed up to 30 days)
Primary	Patient Satisfaction at discharge	1-item measure: I would recommend this [insert program name] to others, assessed at discharge name] to others.	up to 1 week
Primary	Patient Perception of Digital Care at discharge	Results of Digital Care - Likert Scale (very satisfied to very dissatisfied)	up to 1 week
Secondary	Escalations (for management and treatment of early decompensation)	percentage of patients escalated over total hospital digital encounters	up to 2 weeks
Secondary	Unplanned readmission within 30-days of discharge	Number of 30-day readmissions over total number of discharges	up to 30 days
Secondary	Length of Stay	Day of admission to day of discharge, assessed up to 2 months	assessed up to 2 weeks
Secondary	Number of participants with Hospital Acquired Infections	Number of hospital acquired infections reported (CAUTI, CLABSI, etc.)	assessed up to 1 week