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Completed

NCT Number: NCT05082389

Prediction of Hospital Readmissions in SAPV (Specialised Home Palliative Care) Patients

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Carl Gustav Carus

Dresden, Saxony, 01307, Germany

About this study

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Circumstances of Unplanned hospital admission

    Time frame: 18 months

    Hospital admission not intended and/or planned by either professional nor non-professional care givers

Secondary outcomes

  1. Quality of Life of primary non-professional care-giver

    Time frame: 18 months

    Quality of Life as assessed by WHOQOL-BREF (World Health Organization Quality of Life)

  2. Psychological Distress of primary non-professional care-giver

    Time frame: 18 months

    Psychological Distress as assessed by NCCN-Distress Thermometer

  3. Anxiety of primary non-professional care-giver

    Time frame: 18 months

    Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale

  4. Depressivity of primary non-professional care-giver

    Time frame: 18 months

    Depressivity as assessed by the Health Questionnaire depression module 9-item scale

  5. Characteristics of the non-professional care-giver

    Time frame: 18 months

    Characteristics of primary non-professional care giver such as age, gender, kind of relation to the patient, duration of daily care, highest education, employment status

  6. Characteristics of patient

    Time frame: 18 months

    Characteristics of patient such as age, gender, diagnosis, duration of previous hospitalisation, additional supportive services, number of visits by SAPV, symptoms status,

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • University Hospital Dresden

Registry information

Official study title

Prediction of Hospital Readmissions in SAPV (Specialised Home Palliative Care) Patients - Identification of Structural Factors and Support Needs of Family Caregivers

Acronym: PRePP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2021
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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