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

Sponsor
Technische Universität Dresden (Other)
Overall Status
Completed
CT.gov ID
NCT05082389
Collaborator
University Hospital Dresden (Other)
240
1
15.6
15.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    1. 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Hospital Readmissions in SAPV (Specialised Home Palliative Care) Patients - Identification of Structural Factors and Support Needs of Family Caregivers
    Actual Study Start Date :
    Apr 12, 2021
    Actual Primary Completion Date :
    Jun 30, 2022
    Actual Study Completion Date :
    Jul 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Circumstances of Unplanned hospital admission [18 months]

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

    Secondary Outcome Measures

    1. Quality of Life of primary non-professional care-giver [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 [18 months]

      Psychological Distress as assessed by NCCN-Distress Thermometer

    3. Anxiety of primary non-professional care-giver [18 months]

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

    4. Depressivity of primary non-professional care-giver [18 months]

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

    5. Characteristics of the non-professional care-giver [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 [18 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Carl Gustav Carus Dresden Saxony Germany 01307

    Sponsors and Collaborators

    • Technische Universität Dresden
    • University Hospital Dresden

    Investigators

    • Principal Investigator: Katharina Schütte, MD, University Hospital Dresden; Palliative Care Unit
    • Principal Investigator: Leopold Hentschel, Dipl.-Psych., University Hospital Dresden; Department of Psychooncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Technische Universität Dresden
    ClinicalTrials.gov Identifier:
    NCT05082389
    Other Study ID Numbers:
    • BO-EK-320072020
    First Posted:
    Oct 19, 2021
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Technische Universität Dresden

    Study Results

    No Results Posted as of Aug 11, 2022