Home Care Services, Malignant Neoplasm, Quality of LIfe, Unplanned Hospitalization
Conditions
Brief summary
To test the effects of home-based care on unplanned hospitalization within 6 months among advanced cancer patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-ups.
Detailed description
This study is a cluster, non-randomized controlled trial to test the effects of home-based care on unplanned hospitalization in 6 months among advanced cancer patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-up. We are recruiting the study participants from 6 institutions, aiming for 396 cancer patients. Participants for the intervention group will be recruited from Seoul National University Hospital, Chung-ang University Hospital, and Dongguk University Ilsan Hospital. Participants for the control group will be recruited from Kyung Hee University Medical Center, CHA Bundang Medical Center, and Seoul National University Bundang Hospital.
Interventions
OTHERHome-based care
Home-based medical care is based on a specialized home-based medical team approach, including following: 1. Specialized Home-Based Medical Team Approach 2. Initial Assessment and Education 3. Initial Home Visits and Education 4. Multidisciplinary Team Meeting 5. Regular Assessment After the Initial Visit
Sponsors
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
DongGuk University
Kyung Hee University Hospital
Bundang CHA Hospital
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A cluster, non-randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Both the patient and their family caregiver must meet the criteria to be considered for this research. 1. Patient 1. A person who has an advanced-stage solid cancer diagnosis (ICD-10 code C00-C70); A person who is receiving or planning to receive cancer treatment 2. A person who meets one of the following conditions 1. Has been evaluated as having ECOG performance status 2 2. Has been evaluated as having ECOG performance status 1 and is over 70 years of age 3. A person who wishes to stay at home 4. A person whose family caregiver resides at home 5. A person who wishes to participate in the research 2. Family Caregiver 1. A family\* member of the patient \* Family: refers to the patient's spouse (including a common-law partner), descendants and their spouses up to the second degree, siblings and their spouses, and relatives and their spouses up to the eighth degree. 2. A person who meets one of the following conditions: 1. Lives with the patient (patient's household member) 2. Does not live with the patient, but visits the patient's home more than three times a week 3. A person who wants the patient to stay at home 4. A person who can communicate easily with medical staff 5. A person who wishes to participate in the research
Exclusion criteria
If either the patient or the family caregiver meets any one of these criteria, they are excluded from the study. 1. Patient 1. A person who cannot speak, hear, or read Korean 2. A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health 3. A person residing outside the range that can be visited by the respective medical institution (the conditions for distance are to be specified by each medical institution)\* \* This condition is not applicable for the control group. 4. A person who has used hospital- or home-type hospice and palliative care services 5. A person who is under the age of 19 2. Family Caregiver 1. A person who cannot speak, hear, or read Korean 2. A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health 3. A person under the age of 19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned hospitalization | within 6 months following enrollment | 1. admission to the enrolled hospital to treat unexpected symptoms or medical conditions (not including planned admission for chemotherapy or admission for planned surgery or intervention) 2. admission to a hospital other than the enrolled hospital 3. admission to a nursing hospital for a duration of less than 4 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life of patient - ESAS | within 6 months following enrollment | Modified Edmonton Symptom Assessment System (ESAS) of patient |
| Quality of life of patient - EQ-5D | within 6 months following enrollment | Euro-Quality of Life-5 Dimension (EQ-5D) of patient |
| Depressive symptom of patient | within 6 months following enrollment | Patient Health Questionnaire-9 (PHQ-9) of patient |
| Patient medical utilization | within 6 months following enrollment | The total number of hospital utilization, including hospitalization, emergency room visit, and clinic visits |
| Hospitalization | within 6 months following enrollment | the number of hospitalization |
| ER visits | within 6 months following enrollment | the number of emergency room visits |
| Healthcare use | within 6 months following enrollment | the number of healthcare use for severe diseases |
| Patient end-of-life care: ICU admission | within 1 month before death | ICU admission one month before death |
| Patient end-of-life care: an advance directive | within 1 month before death | Completion of advance medical directives within 1 month before death |
| Satisfaction with services (patient) | within 6 months following enrollment | Satisfaction of the study participant (patient) with the service in this study, evaluated by questionnaire |
| Quality of life of family caregiver | within 6 months following enrollment | Euro-Quality of Life-5 Dimension (EQ-5D) of family caregiver |
| Care burden of family caregiver | within 6 months following enrollment | The Korean version of Caregiver Reaction Assessment (CRA-K) of family caregiver |
| Depressive symptom of family caregiver | within 6 months following enrollment | Patient Health Questionnaire-9 (PHQ-9) of family caregiver |
| Caring competency of family caregiver | within 6 months following enrollment | Caring competency of family caregiver, measured by questionnaire |
| Satisfaction with services (family caregiver) | within 6 months following enrollment | Satisfaction of the study participant (family caregiver) with the service in this study, evaluated by questionnaire |
| Expenses | within 6 months following enrollment | medical expenses, care expenses |
| Patient end-of-life care: ventilator treatment | within 1 month before death | Mechanical ventilator apply one month before death |
Countries
South Korea
Contacts
Primary ContactGa-Young Lee
Backup ContactSo-Hee Kim
Outcome results
None listed