Home HospitalizationARCNCT06049875
Characteristics Associated With Duration of Home Hospitalization in Internal Department Versus Hospitalization in the Hospital in Internal Ward
An observational study of Home Hospitalization, run by Sheba Medical Center at 3 sites in Israel.
Trial summary
According to data from the OECD - Organization for Economic Co-operation and Development, the hospitalization crisis in Israel's hospitals is getting worse, both in relation to previous years in the State of Israel and in comparison to other countries [1]. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Home Hospitalization
- How many people
- 200 participants
- Where
- 3 sitesIsrael
- Study dates
- 2 Jul 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target population is all patients who come from the community to the hospital's emergency room in Israel, who come to the emergency room for hybrid home hospitalization or hospitalization in an internal hospital department. The population accessible to the study is patients aged 18 and over who come to the emergency room for treatment and meet the inclusion criteria.
Who may be able to join
- Criteria for the inclusion of the patients who come to the cognitive screening and who speak Hebrew to sign an informed consent with diagnoses:
- Respiratory infections in a patient who does not suffer from immunodeficiency
- Infection of the urinary tract in a patient who does not suffer from immunodeficiency
- Soft tissue infection of the lower limbs in a patient who does not suffer from immunodeficiency
- Flare-up of chronic obstructive pulmonary disease in a patient who does not demonstrate respiratory failure in the emergency department
- Infection of the upper/lower digestive tract in a patient who does not suffer from immunodeficiency
- Starting the investigation of a prolonged febrile illness of unknown origin in a patient who does not suffer from immunodeficiency
- Flare-up of heart failure in a respiratory and hemodynamically stable patient - including hypoxemia
Who cannot join
- Patients who do not speak Hebrew
- Patients who came to the emergency department with delirium
- Patients who do not have the appropriate conditions for home hospitalization - terminally ill, lack of family support, and lack of ability to operate technologies in a home setting
- Patients with hemodynamic, respiratory or neurological instability.
- Patients whose treatment requires the use of measures or drugs that cannot be provided in a hospital setting
- Unbalanced psychiatric patients
- Patients who live within a radius of more than 50 km from Sheba Hospital (according to the procedure of the Ministry of Health)
- Patients who are not interested in home hospitalization / or who were hospitalized during home hospitalization
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Difference between tow independent mean -tow groups
Ramat Gan, 00000
Daniella BTIMT Daliyot, master, 0503381312 ext. 000, danidaliyot@gmail.com
Daniella Daliyot, 0503381312 ext. 000, danidaliyot@gmail.com
- Recruiting
Sheba Medical Center
Ramat Gan, 00000
Daniella Daliyot, 0503381312, danidaliyot@gmail.com
Daniella Daliyot, MASTER
- Recruiting
Daniella Daliyot
Ramat Gan, 52621
Daniella Daliyot, master, 0503381312, danidaliyot@gmail.com
Daniella Daliyot, master
About this study
Official title: Characteristics Associated With Duration of Home Hospitalization in Internal Department Versus Hospital in Internal Ward
According to data from the OECD - Organization for Economic Co-operation and Development, the hospitalization crisis in Israel's hospitals is getting worse, both in relation to previous years in the State of Israel and in comparison to other countries [1]. There is an increase in life expectancy and the rate of aging of the population, which results in an increase in the number of beds in hospitals in relation to the growth rate of the population in need of treatment [2]. Furthermore, the government does not have the ability or an understandable plan for a significant and rapid increase in the number of hospital beds in the country. Instead, there is a recognition and a strategic decision by government officials in Israel, backed by the publication of relevant support tests [3], to develop hospitalization alternatives to hospital beds, primarily hospitalization within the community in the patient's natural environment, i.e. at home [4]. In a meta-analysis performed on patients with chronic diseases, it was found that the duration of treatment received by patients at home was 5.4 days longer compared to patients receiving treatment at the hospital, the risk of mortality was the same, re-hospitalization was lower among the patients hospitalized at home and the risk of worsening of the medical condition was smaller in 26 percent in hospitalization at home compared to hospitalization in the hospital [5]. For the patient receiving long-term care, it is extremely essential to be in a familiar and safe environment. Additional advantages to home hospitalization are a decrease in the chances of infection compared to the hospital and support from family members, both emotionally and physically [6].
Around the world, more and more experience is being accumulated in operating home hospitalizations as a substitute for hospitalization in a hospital. Comparative studies in diverse populations showed, already 20 years ago, that hospitalization at home is preferable to hospitalization in a hospital when it comes to the quality of life in a supportive and familiar environment [7]. However, the issue of the economic viability of home hospitalizations, whose cost was higher in the past, remains under question. There are studies that show a decrease in the cost of treatment in the home environment even in complex treatments and by professional teams [8]. Technological developments in the field of remote medicine have greatly contributed to improving the quality of care provided at home. Today, medical technology allows a patient who has been discharged from the hospital to be hospitalized at home, which allows the patient to continue to be treated at home through close medical and nursing supervision and advanced technological equipment. The technological development also allows cost reduction in different clinical settings such as: patients suffering from a flare-up of obstructive pulmonary disease [10,9], patients who are transferred to home hospitalization after surgery, elderly patients suffering from chronic diseases and needing hospitalization due to pneumonia and soft tissue infections, and patients suffering from exacerbation of heart failure [11]. The Ministry of Health and Welfare in the United States estimates that in 2030 one out of 5 Americans will be over the age of 65 and that home hospitalization is the preferred way to provide care to the patient as well as the optimal way in terms of costs [12]. This phenomenon will intensify the need for home hospitalization and will lead to improvements in the home sector [13].
Read more
At the Haim Sheba Tertiary Medical Center, they combine unique capabilities that make it particularly suitable for launching a home hospitalization service. The internal departments of the medical center are experienced in managing complex patients. The management of the departments is based on experts in internal medicine who have extensive experience in specializing in In the management of complex cases, with a high turnover of patients with mild and moderate degrees of severity, the hospital's position also matches the position of the relevant professional body - the Israeli Association of Internal Medicine - in regards to the launch of home hospitalization.
A center for innovation in digital health was established in Sheba, the purpose of which is to test and implement advanced technologies of remote medicine. Examining and operating these technologies, while having a unique collaboration with the companies that develop and manufacture them, places the innovation in an excellent opening position in terms of the ability to evaluate and operate the existing technologies in the hands of the doctors in the medical center.
Read the detailed description
The purpose of the program:
Characterization, establishment and operation of a home hospitalization program managed by a hybrid division.
The target population is all patients who come from the community to the hospital's emergency room in Israel, who come to the emergency room for hybrid home hospitalization or hospitalization in an internal hospital department. The population accessible to the study is patients aged 18 and over who come to the emergency room for treatment and meet the inclusion criteria.
- Conditions
- Home Hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Home Hospitalization | Patients who arrived at the emergency department and were discharged to home hospitalization or were hospitalized for a day and discharged to comprehensive home hospitalization under the management of a remote internist and a nurse who will make home visits on a daily basis. | |
| Internal Ward Hospitalization | Patients who arrived at the emergency department and received a regular treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of hospitalization will differ between hospitalization in an internal ward and hospitalization at home.
We expect that the duration of home hospitalization will be shorter than that of hospitalization in an internal ward. This outcome will be measured using descriptive analysis.
Measured: 01/07/2023-01/12/2024
The number of re-hospitalizations will differ between hospitalization in an internal ward and hospitalization at home.
We expect that the number of re-hospitalizations of home hospitalization will be lower than that of hospitalization in an internal ward. This outcome will be measured using descriptive analysis.
Measured: 01/07/2023-01/12/2024
The level of satisfaction will differ between hospitalization in an internal ward and hospitalization at home.
We expect that the level of satisfaction of home hospitalization will be higher than that of hospitalization in an internal ward. This outcome will be measured using the PPEQ-15 questionnaire.
Measured: 01/07/2023-01/12/2024
The cost of hospitalization will differ between hospitalization in an internal ward and hospitalization at home.
We expect that the cost of home hospitalization will be lower than that of hospitalization in an internal ward. This outcome will be measured using descriptive analysis.
Measured: 01/07/2023-01/12/2024
Clinical outcomes will differ between hospitalization in an internal ward and hospitalization at home.
We anticipate differences in aspects of clinical deterioration of the patient, falls, new infection, delirium and death. This outcome will be measured using the NEWS-2 questionnaire.
Measured: 01/07/2023-01/12/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start2 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home HospitalizationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Gad Segal, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049875
- Sponsor's protocol ID
- Sheba 0096 GS 2023 CTIL
- Acronym
- ARC
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics Associated With Duration of Home Hospitalization in Internal Department Versus Hospital in Internal Ward
- ClinicalTrials.gov ID
- NCT06049875
- Acronym / sponsor ID
- ARC / Sheba 0096 GS 2023 CTIL
- Conditions
- Home Hospitalization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 2 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to data from the OECD - Organization for Economic Co-operation and Development, the hospitalization crisis in Israel's hospitals is getting worse, both in relation to previous years in the State of Israel and in comparison to other countries [1]. There is an increase in life expectancy and the rate of aging of the population, which results in an increase in the number of beds in hospitals in relation to the growth rate of the population in need of treatment [2]. Furthermore, the government does not have the ability or an understandable plan for a significant and rapid increase in the number of hospital beds in the country. Instead, there is a recognition and a strategic decision by government officials in Israel, backed by the publication of relevant support tests [3], to develop hospitalization alternatives to hospital beds, primarily hospitalization within the community in the patient's natural environment, i.e. at home [4]. In a meta-analysis performed on patients with chronic diseases, it was found that the duration of treatment received by patients at home was 5.4 days longer compared to patients receiving treatment at the hospital, the risk of mortality was the same, re-hospitalization was lower among the patients hospitalized at home and the risk of worsening of the medical condition was smaller in 26 percent in hospitalization at home compared to hospitalization in the hospital [5]. For the patient receiving long-term care, it is extremely essential to be in a familiar and safe environment. Additional advantages to home hospitalization are a decrease in the chances of infection compared to the hospital and support from family members, both emotionally and physically [6].
Around the world, more and more experience is being accumulated in operating home hospitalizations as a substitute for hospitalization in a hospital. Comparative studies in diverse populations showed, already 20 years ago, that hospitalization at home is preferable to hospitalization in a hospital when it comes to the quality of life in a supportive and familiar environment [7]. However, the issue of the economic viability of home hospitalizations, whose cost was higher in the past, remains under question. There are studies that show a decrease in the cost of treatment in the home environment even in complex treatments and by professional teams [8]. Technological developments in the field of remote medicine have greatly contributed to improving the quality of care provided at home. Today, medical technology allows a patient who has been discharged from the hospital to be hospitalized at home, which allows the patient to continue to be treated at home through close medical and nursing supervision and advanced technological equipment. The technological development also allows cost reduction in different clinical settings such as: patients suffering from a flare-up of obstructive pulmonary disease [10,9], patients who are transferred to home hospitalization after surgery, elderly patients suffering from chronic diseases and needing hospitalization due to pneumonia and soft tissue infections, and patients suffering from exacerbation of heart failure [11]. The Ministry of Health and Welfare in the United States estimates that in 2030 one out of 5 Americans will be over the age of 65 and that home hospitalization is the preferred way to provide care to the patient as well as the optimal way in terms of costs [12]. This phenomenon will intensify the need for home hospitalization and will lead to improvements in the home sector [13].
At the Haim Sheba Tertiary Medical Center, they combine unique capabilities that make it particularly suitable for launching a home hospitalization service. The internal departments of the medical center are experienced in managing complex patients. The management of the departments is based on experts in internal medicine who have extensive experience in specializing in In the management of complex cases, with a high turnover of patients with mild and moderate degrees of severity, the hospital's position also matches the position of the relevant professional body - the Israeli Association of Internal Medicine - in regards to the launch of home hospitalization.
A center for innovation in digital health was established in Sheba, the purpose of which is to test and implement advanced technologies of remote medicine. Examining and operating these technologies, while having a unique collaboration with the companies that develop and manufacture them, places the innovation in an excellent opening position in terms of the ability to evaluate and operate the existing technologies in the hands of the doctors in the medical center.
Detailed description
The purpose of the program:
Characterization, establishment and operation of a home hospitalization program managed by a hybrid division.
The target population is all patients who come from the community to the hospital's emergency room in Israel, who come to the emergency room for hybrid home hospitalization or hospitalization in an internal hospital department. The population accessible to the study is patients aged 18 and over who come to the emergency room for treatment and meet the inclusion criteria.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Hospitalization | – | –Patients who arrived at the emergency department and were discharged to home hospitalization or were hospitalized for a day and discharged to comprehensive home hospitalization under the management of a remote internist and a nurse who will make home visits on a daily basis. |
| Internal Ward Hospitalization | – | –Patients who arrived at the emergency department and received a regular treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population is all patients who come from the community to the hospital's emergency room in Israel, who come to the emergency room for hybrid home hospitalization or hospitalization in an internal hospital department. The population accessible to the study is patients aged 18 and over who come to the emergency room for treatment and meet the inclusion criteria.
Key inclusion criteria (8 listed)
- Criteria for the inclusion of the patients who come to the cognitive screening and who speak Hebrew to sign an informed consent with diagnoses:
- Respiratory infections in a patient who does not suffer from immunodeficiency
- Infection of the urinary tract in a patient who does not suffer from immunodeficiency
- Flare-up of chronic obstructive pulmonary disease in a patient who does not demonstrate respiratory failure in the emergency department
- Infection of the upper/lower digestive tract in a patient who does not suffer from immunodeficiency
Key exclusion criteria (8 listed)
- Patients who do not speak Hebrew
- Patients who came to the emergency department with delirium
- Patients who do not have the appropriate conditions for home hospitalization - terminally ill, lack of family support, and lack of ability to operate technologies in a home setting
- Patients with hemodynamic, respiratory or neurological instability.
- Patients whose treatment requires the use of measures or drugs that cannot be provided in a hospital setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The length of hospitalization will differ between hospitalization in an internal ward and hospitalization at home.
Time frame: 01/07/2023-01/12/2024
We expect that the duration of home hospitalization will be shorter than that of hospitalization in an internal ward. This outcome will be measured using descriptive analysis.
The number of re-hospitalizations will differ between hospitalization in an internal ward and hospitalization at home.
Time frame: 01/07/2023-01/12/2024
We expect that the number of re-hospitalizations of home hospitalization will be lower than that of hospitalization in an internal ward. This outcome will be measured using descriptive analysis.
The level of satisfaction will differ between hospitalization in an internal ward and hospitalization at home.
Time frame: 01/07/2023-01/12/2024
We expect that the level of satisfaction of home hospitalization will be higher than that of hospitalization in an internal ward. This outcome will be measured using the PPEQ-15 questionnaire.
The cost of hospitalization will differ between hospitalization in an internal ward and hospitalization at home.
Time frame: 01/07/2023-01/12/2024
We expect that the cost of home hospitalization will be lower than that of hospitalization in an internal ward. This outcome will be measured using descriptive analysis.
Clinical outcomes will differ between hospitalization in an internal ward and hospitalization at home.
Time frame: 01/07/2023-01/12/2024
We anticipate differences in aspects of clinical deterioration of the patient, falls, new infection, delirium and death. This outcome will be measured using the NEWS-2 questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
Related trials for Home Hospitalization
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Recruiting
Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training
Acute Hospitalization
Not yet recruiting
HomeCare Medication Management for People With Dementia
Dementia, Alzheimer's Disease and Related Dementias
Not yet recruiting
Feasibility Study on the Implementation of a Program to Facilitate the Return Home of Patients With Heart Failure Following Hospitalization, Led by a Coordinated Multidisciplinary Team Based on the "Team-based Care" Model
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Difference between tow independent mean -tow groups
Ramat Gan, Israel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Hospitalization, run by Sheba Medical Center at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of hospitalization will differ between hospitalization in an internal ward and hospitalization at home. (time frame: 01/07/2023-01/12/2024). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.