Hospital@Home: Improving discharge management for complex and multi-ill patients

Switzerland (ICTRP)

ICTRP Studien-ID
ISRCTN11162162 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Hospital@Home: Improving Discharge Management of Complex and Multimorbid Patients (BASEC)

Wissenschaftlicher Titel
Hospital@Home: Improving discharge management and reducing the risk of rehospitalizations in multimorbid Patients (ICTRP)

Öffentlicher Titel
Hospital at home ? a study to reduce rehospitalizations (ICTRP)

Untersuchte Krankheit(en)
Rrisk for unplanned rehospitalizations in multimorbid patients discharged from the hospital
Not Applicable (ICTRP)

Untersuchte 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), id (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Pragmatic single-center randomized open-label superiority trial (Prevention) (ICTRP)

Ein-/Ausschlusskriterien
Gender: Both
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 (ICTRP)

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

Primäre und sekundäre Endpunkte
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. (ICTRP)

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 (ICTRP)

Registrierungsdatum
04.04.2023 (ICTRP)

Einschluss des ersten Teilnehmers
04.05.2023 (ICTRP)

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
nicht verfügbar

Sekundäre IDs
Nil known, Nil known, SNCTP000005155, BASEC2022-01040 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
YesAvailable on request. 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. (ICTRP)

Weitere Informationen zur Studie
https://www.isrctn.com/ISRCTN11162162 (ICTRP)