Hospital at home – a study to reduce rehospitalizations
| ISRCTN | ISRCTN11162162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11162162 |
| Secondary identifying numbers | SNCTP000005155, BASEC2022-01040 |
- Submission date
- 28/01/2023
- Registration date
- 04/04/2023
- Last edited
- 29/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The aim of the Hospital@Home study is to reduce the rehospitalization rate in in-hospital patients on a medical ward at high risk of rehospitalization. The intervention consists of a targeted multidisciplinary intervention over 5 days after hospital discharge and aims to ensure an optimal transition from hospital to ambulatory care. The primary objective is to reduce the rate of unplanned rehospitalisation in the aforementioned patient group by 25%.
Who can participate?
Hospital inpatients at high risk of rehospitalization scheduled for discharge to their home
What does the study involve?
In addition to the standard-of-care counseling prior to hospital discharge, patients in the intervention group will be contacted by telephone daily for 5 days, starting on the day after hospital discharge. They will be asked about their general well-being, need for support in their daily care, and their adherence to prescribed medications. If a home visit is deemed necessary before discharge or on one of the daily phone calls, the visit will be carried out by a member of the study team. Members of the Hospital@Home study team will coordinate the discharge management prior to discharge, such as ensuring that all the necessary paperwork is present, organizing and coordinating post-discharge outpatient care, organizing any necessary material and medication and follow-up appointments with primary care physicians.
What are the possible benefits and risks of participating?
Participants could potentially receive a direct benefit from participation if they receive additional care from the Hospital@Home team. The goal of the intervention is to improve patient care in the home environment by coordinating the various inpatient and outpatient services involved, thus reducing unplanned readmissions and increasing patient satisfaction with the discharge procedure. No risks are expected.
Where is the study run from?
Cantonal Hospital of Baden, Canton Aargau (Switzerland)
When is the study starting and how long is it expected to run for?
November 2021 to January 2026
Who is funding the study?
1. Department of Health, Canton of Aargau (Switzerland)
2. Stiftung Kardio (Switzerland)
Who is the main contact?
Prof. Dr. med. M. Wertli, maria.wertli@ksb.ch
Contact information
Principal Investigator
Im Ergel 1
Baden AG
5404
Switzerland
| Phone | +41 56 486 25 02 |
|---|---|
| maria.wertli@ksb.ch |
Study information
| Study design | Pragmatic single-center randomized open-label superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Hospital@Home: Improving discharge management and reducing the risk of rehospitalizations in multimorbid Patients |
| Study acronym | H@H |
| Study objectives | Current study hypothesis as of 29/10/2024: We hypothesize that through a targeted multidisciplinary intervention, the risk of rehospitalization within 30 days in high-risk patients can be reduced by at least 25%. Such a reduction would result in substantial individual and societal benefits. _____ Previous study hypothesis: It is hypothesized that through a targeted multidisciplinary intervention over 5 days after hospital discharge, the risk of rehospitalization within 30 days in high-risk patients can be reduced by at least 25%. |
| Ethics approval(s) | Approved 30/09/2022, Ethikkommission Nordwest- und Zentralschweiz EKNZ (Hebelstrasse, 53 4056, Basel, Switzerland; +41 (0)61 268 13 50; eknz@bs.ch); ref: 2022-01040 |
| Health condition(s) or problem(s) studied | Rrisk for unplanned rehospitalizations in multimorbid patients discharged from the hospital |
| Intervention | Current interventions as of 29/10/2024: The multimodal intervention includes several transitional care components per discharge phase: pre-discharge, bridging, and post-discharge interventions. Pre-discharge interventions Patients will receive individualized discharge management by an APN of the Hospital@Home team in addition to standard-of-care counseling. For each patient, the APN will instruct self-management, conduct medication reconciliation and review, assess the needs for post-discharge care coordination, improve the discharge summary and care plan, and involve the family as needed. Bridging interventions Bridging interventions such as coordination and planning of outpatient follow-up appointments with primary care physicians or community nurses and availability of material and medication upon discharge (coordination with pharmacies) are used as needed. In addition to patient education, communication with the outpatient healthcare team (primary care physicians, specialists, and community nurses) and family members ensures that patients are aware of appointments and changes to their care plan. A scheduled home visit can also serve as a bridging intervention to directly hand over patients to the community nurses (e.g., for patients with intravenous therapy or supply and/or drainage systems). Post-discharge intervention Patients will receive structured telephone follow-up daily for 5 days (weekdays only) following the discharge. The telephone calls will focus on the following aspects: • Assessment of symptoms and vital signs, general well-being, and organizational issues; • Potentially adjustments to medications based on the treatment plan; • Medication adherence, structured needs assessment to organize missing medications or material (e.g. wound dressings), identification of the need for home visits and follow-up visits; • Counseling on health-related issues, patient and family education; • Organizing and coordinating additional follow-up visits with primary care physicians and specialists; • Organizing and coordinating care with community nurses (if necessary) During the first 5-days post-discharge, the Hospital@Home team may conduct home visits, if needed. Home visits are performed by APN and/or a physician and are aimed at avoiding the need for rehospitalization by early treatment adjustments. Patients in the intervention group will be able to call a hotline to contact the Hospital@Home team during workdays to ask questions or to receive help. Control procedures Patients assigned to the control arm will receive the current standard-of-care counselling before hospital discharge. The nurse care manager team will provide a summary of discharge recommendations and organize outpatient care. In each patient the responsible resident physician will review the discharge medication, conduct a medication reconciliation, and explain the updated medication _____ Previous interventions: Patients with a BARRS-Score ≥5 will be randomised after providing written informed consent. The researchers will use blinded group allocation by randomizing patients into an intervention and a control group using the study software RedCap. A randomization list will be generated by a statistician otherwise not involved in the study. The randomization will be stratified based on the presence/absence of active cancer and/or heart insufficiency. Patients will be randomly assigned into two parallel groups: 1. Intervention: The Hospital@Home care team will follow up patients for 5 days 2. Control group: usual discharge without follow-up Patients in the intervention arm will – in addition to the standard-of-care counseling prior to hospital discharge – receive a multidisciplinary, coordinated 5-day care at their home, starting on the day after discharge. Members of the Hospital@Home study team will coordinate the discharge management prior to discharge, such as ensuring that all the necessary paperwork is present, organizing and coordinating post-discharge outpatient care, organizing any necessary material and medication and follow-up appointments with primary care physicians. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 29/10/2024: The primary outcome is the rate of first unplanned rehospitalizations within 30 days after discharge from the index admission. An unplanned rehospitalization is defined as an unscheduled admission to any hospital and any division within 30 days after discharge. _____ Previous primary outcome measure: The rate of unplanned rehospitalizations in the high-risk group (BARRS score ≥5) at 30 days after discharge. Planned (elective) rehospitalizations will not be counted as events. This information is collected by a phone call at 30 days after discharge. |
| Secondary outcome measures | Current secondary outcome measures as of 29/10/2024: 1. The rate of unplanned rehospitalizations in the high-risk group (BARRS score ≥ 5) 18 days after discharge. 2. Change in quality of life between discharge and 30 days after discharge, using the EQ5D-5L 3. Quality of life after 30 days, using the EQ5D-5L 4. Death within 30 days 5. Health care use (e.g., physicians’ visits, emergency department visits) within 30 days 6. Patient satisfaction with the discharge management at 30 days, using a clinic-specific questionnaire (TEA) _____ Previous secondary outcome measures: 1. The rate of unplanned rehospitalizations in the high-risk group (BARRS score ≥5) 18 days after discharge. This information is collected by a phone call 30 days after discharge 2. Quality of life measured by EQ-5D questionnaire at discharge and 30 days after discharge 3. Patient satisfaction with discharge management, as measured by the Transition Evaluation Assessment Tool (TEA) at 5 days after discharge |
| Overall study start date | 21/11/2021 |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | The sample size is 681 patients in each arm. Assuming a 20% drop-out rate, the final target sample size will be 1704 patients (852 in each group). |
| Key inclusion criteria | Current participant inclusion criteria as of 25/11/2024: Patients ≥18 years old with a high risk (estimated risk ≥20%) for unplanned rehospitalization who consent to participate are included in this RCT, if they meet the following inclusion criteria: 1. Hospital inpatients with a high risk (estimated risk ≥20%) for unplanned rehospitalization (BARRS-Score of ≥5 points) who are scheduled for discharge to their home 2. Patient and/or proxy must be able to give written informed consent 3. Patient and/or proxy must be able to communicate in German _____ Previous participant inclusion criteria as of 29/10/2024 to 25/11/2024: 1. Hospital inpatients with a high risk (estimated risk ≥20%) for unplanned rehospitalization (BARRS-Score of ≥5 points) scheduled for discharge to their home 2. Patient must be able to give written informed consent _____ Previous participant inclusion criteria: 1. Hospital inpatients with a BARRS-Score of ≥5 points scheduled for discharge to their home 2. Patient must be able to communicate in the German language 3. Patient must be able to give written informed consent |
| Key exclusion criteria | Current participant exclusion criteria as of 25/11/2024: Patients are excluded if they meet the following criteria: 1. Discharge to other institutions (e.g., rehabilitation facilities, nursing homes); 2. Patients or proxy that are not able to understand the trial (e.g., cognitive impairment, language barrier); 3. Anticipated death within 30 days of the trial period; 4. Planned hospitalization within the next 30 days; 5. Unacceptable distance for home visits (>20 km away from the hospital); 6. Prior participation in the current trial (electronic health record will be labeled). _____ Previous participant exclusion criteria as of 29/10/2024 to 25/11/2024: 1. Discharge to other institutions (e.g., rehabilitation facilities, nursing homes); 2. Patients that are not able to understand the trial (e.g., cognitive impairment, language barrier); 3. Anticipated death within 30 days of the trial period; 4. Planned hospitalization within the next 30 days; 5. Unacceptable distance for home visits (>20 km away from the hospital); 6. Prior participation in the current trial (electronic health record will be labelled). _____ Previous exclusion criteria: 1. Patients discharged to other institutions, including rehabilitation facilities, nursing homes 2. Inability/unwillingness to give informed consent, e.g. due to cognitive impairment or language barrier 3. Patients who are scheduled for a planned hospitalization within the next 30 days 4. Patients who live more than 20 km away from the hospital 5. Previous participation in the trial |
| Date of first enrolment | 04/05/2023 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Im Ergel 1
Baden AG
5404
Switzerland
Sponsor information
Hospital/treatment centre
Im Ergel 1
Baden
5404
Switzerland
| Phone | +41 (0)56 486 21 71 |
|---|---|
| philippe.scheuzger@ksb.ch | |
| Website | http://www.kantonsspitalbaden.ch/ |
"ROR" |
https://ror.org/034e48p94 |
Funders
Funder type
Charity
No information available
No information available
Results and Publications
| Intention to publish date | 01/07/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Upon completion of the study, the datasets generated analysed will be made available upon reasonable request from the clinical trial unit KSB (ctu@ksb.ch). Data that will be shared, will need to comply with legal restrictions and be fully anonymized. |
Editorial Notes
29/11/2024: The following changes have been made:
1. The intention to publish date was changed from 01/02/2025 to 01/07/2027.
2. The overall study end date was changed from 31/12/2026 to 31/01/2027.
25/11/2024: The following changes have been made:
1. The Sponsor was amended from Schweizerische Herzstiftung to Stiftung Kardio.
2. The overall study end date was changed from 01/05/2025 to 31/12/2026.
3. The participant inclusion and exclusion criteria were updated.
4. The recruitment end date was changed from 31/01/2025 to 31/12/2026.
29/10/2024: The following changes were made to the trial record:
1. The secondary outcome measures were changed.
2. The study hypothesis was changed.
3. The scientific title was changed from "Hospital@Home: improving discharge management of complex and multimorbid patients" to "Hospital@Home: Improving discharge management and reducing the risk of rehospitalizations in multimorbid Patients".
4. The study design was changed from "Pragmatic randomized two-arm open monocentric trial" to "Pragmatic single-center randomized open-label superiority trial".
5. The intervention were changed.
6. The primary outcome measure was changed.
7. The inclusion criteria were changed.
8. The target number of participants was changed from "A sample size of 681 patients in each group was calculated in order to have 80% power to detect a difference in rehospitalization rate between the two groups with one-sided significance level 0.05 when the proportion of patients experiencing rehospitalization is 0.19 in the control group and 0.14 in the intervention group. This yields a total of 1362 included patients." to "The sample size is 681 patients in each arm. Assuming a 20% drop-out rate, the final target sample size will be 1704 patients (852 in each group).".
9. The exclusion criteria were changed.
05/06/2024: The participant level data sharing statement was added.
17/05/2023: The recruitment start date was changed from 28/02/2023 to 04/05/2023.
13/02/2023: Trial's existence confirmed by the Ethikkommission Nordwest- und Zentralschweiz EKNZ.
