Clinical trial NCT05082389: Prediction of Hospital Readmissions in SAPV (Specialised Home Palliative Care) Patients
Official title: Prediction of Hospital Readmissions in SAPV (Specialised Home Palliative Care) Patients - Identification of Structural Factors and Support Needs of Family Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Care
Keywords: Patient reported outcome (PRO)
family caregivers
specialized palliative home-based care
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: University Hospital Dresden
First posted: 2021-10-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated in SAPV University hospital Dresden will be investigated by descriptive statistics. All respective non-professional-caregivers will be asked to take part in the survey. They must meet the aforementioned inclusion criteria and provide informed consent.

Brief summary: Specialised outpatient palliative care (German: Spezialisierte ambulante Palliativversorgung, abbreviation: SAPV) aims to support incurably ill or dying people spending their last lifetime at home. Furthermore, a major goal is to prevent unnecessary hospital admissions. However, they occasionally occur for various reasons. This project aims to explore predictors of readmission in terms of structural factors as well as family caregivers' psychological distress.

Study Aims

1. Identification of structural predictors and caregiver reported predictors for hospital readmissions.
2. Identification of psychological liabilities of nursing relatives.
3. Developing a concept to support nursing relatives.

Detailed description: 1. Background Specialised outpatient palliative care (German: Spezialisierte ambulante Palliativversorgung, abbreviation: SAPV) aims to support incurably ill or dying people spending their last lifetime at home if possible.

   At the same time unnecessary hospital readmissions should be prevented. However, they occasionally occur for various reasons. Due to an analysis of own data including 81 patient of our institution we found the following structural factors influencing hospital readmissions: On average there are 1.3 hospital admissions per patient while receiving palliative care. The quality of home-based care is one factor for hospital readmission. Especially patients´ high symptom burden as well as caregivers´ report of depression and anxiety lead to unplanned hospital readmissions.

   Former studies show a major impact of psychosocial pressure of relatives, for example sadness, sorrows, and exhaustion). High scores of distresses seem to correlate with a higher number of unfulfilled needs. About one third of the nursing relatives reached high scores concerning anxiety and depression. Moreover, an elevated level of resilience relates to a positive opinion of health, better social support, and a decreased rate of depressions of patients who suffer from metastasised oncological diseases. Life quality of nursing relatives is not only decreased in a psychological way but in all parts of life and is influenced by spiritual well-being and by the relation of the patient and the nursing person. The relevance of stable relationship between familiar and professional helpers is also described by Roen and his colleagues.
2. Methods This study is designed as a single-arm, single institution, non-randomized observational study.

The primary study aim is to investigate structural, and caregiver reported reasons for hospital readmission. Burden and needs for support of informal caregivers that lead to a failure of ambulatory care should be identified. Afterwards experts will develop strategies to improve the identified factors and therefore reduce the number of unnecessary hospital readmissions.

2.1 Primary goal Are there any structural or caregiver reported factors influencing hospital readmission during concomitant care by SAPV?

2.2 Secondary goals To explore the burden and supportive-care needs experience informal caregivers caring for patients with an incurable and progressive disease at home? Which concepts can be developed to improve pressures and needs for support of nonprofessional caregivers during the patients´ palliative care?

2.3 Patients This study aims to include consecutively 240 patients of our institution's specialized outpatient palliative care team.

2.4 Primary and Secondary endpoints Primary outcome is the number of unplanned admissions. An unplanned admission is defined as any hospital stay not being previously planned as part of intended treatment.

Secondary endpoints include structural data taken from the patients´ medical records. Furthermore, four validated questionnaires will be administered to obtain family caregiver reported factors:

* quality of life (WHOQOL BREF (WHO \| WHO Quality of Life-BREF (WHOQOL-BREF), n.d.)
* psychological distress (NCCN Distress Thermometer)
* anxiety (Generalized Anxiety Disorder 7-item scale)
* depression (Health Questionnaire depression module 9- item scale).

In addition, a non-standardized questionnaire identifying the burden of relatives caused by the SARS-CoV-2-pandemia is administered.

The following structural data concerning the informal caregiver will be evaluated: age, sex, relationship to the patient, amount of care, educational background, and actual working situation.

The following structural data concerning the patient will be registered: age, sex, diagnosis justifying imbursement of palliative care, duration of palliative care, hospital admissions during SAPV, support by informal caregivers, level of care, use of home-based services, home hospice, reason for hospital admissions, concomitant cancer therapy, data concerning the hospital admission, place of discharge. Information will be collected from the patients´ medical records.

Nurses of SAPV will answer surprise questions monthly: There will be one surprise question concerning patients´ death and another one concerning the probability of hospital readmission.

Eligibility criteria: Inclusion Criteria:

* adult patients (\>17years)
* with advanced, non-curable disease with limited life expectancy and complex symptoms
* treated by a Specialised Home Palliative Care - team
* providing informed consent

Primary outcomes:
measure: Circumstances of Unplanned hospital admission
timeFrame: 18 months
Secondary outcomes:
measure: Quality of Life of primary non-professional care-giver
timeFrame: 18 months
measure: Psychological Distress of primary non-professional care-giver
timeFrame: 18 months
measure: Anxiety of primary non-professional care-giver
timeFrame: 18 months
measure: Depressivity of primary non-professional care-giver
timeFrame: 18 months
measure: Characteristics of the non-professional care-giver
timeFrame: 18 months
measure: Characteristics of patient
timeFrame: 18 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
state: Saxony
Study officials:
affiliation: University Hospital Dresden; Palliative Care Unit
name: Katharina Schütte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Dresden; Department of Psychooncology
name: Leopold Hentschel, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
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