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Palliative CarePRePPNCT05082389

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

An observational study of Palliative Care, run by Technische Universität Dresden at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Palliative Care
How many people
240 participants
Where
1 siteGermany
Study dates
12 Apr 2021to 30 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Carl Gustav Carus

    Dresden, Saxony, 01307

Other trials in Germany

About this study

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

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.
Read the 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.

Conditions
Palliative Care
Keywords
Patient reported outcome (PRO), family caregivers, specialized palliative home-based care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circumstances of Unplanned hospital admission

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

    Measured: 18 months

Secondary outcomes (6)

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

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

    Measured: 18 months

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

    Psychological Distress as assessed by NCCN-Distress Thermometer

    Measured: 18 months

  3. Anxiety of primary non-professional care-giver

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

    Measured: 18 months

  4. Depressivity of primary non-professional care-giver

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

    Measured: 18 months

  5. Characteristics of the non-professional care-giver

    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

    Measured: 18 months

  6. Characteristics of patient

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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start12 Apr 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05082389
Sponsor's protocol ID
BO-EK-320072020
Acronym
PRePP
Status last verified
Aug 2022
First submitted
4 May 2021
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ullrich A, Ascherfeld L, Marx G, Bokemeyer C, Bergelt C, Oechsle K. Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients. BMC Palliat Care. 2017 May 10;16(1):31. doi: 10.1186/s12904-017-0206-z.

    PubMed 28486962

  • Gotze H, Brahler E, Gansera L, Schnabel A, Gottschalk-Fleischer A, Kohler N. Anxiety, depression and quality of life in family caregivers of palliative cancer patients during home care and after the patient's death. Eur J Cancer Care (Engl). 2018 Mar;27(2):e12606. doi: 10.1111/ecc.12606. Epub 2016 Nov 17.

    PubMed 27859889

  • Halkett GKB, Lobb EA, Shaw T, Sinclair MM, Miller L, Hovey E, Nowak AK. Do carer's levels of unmet needs change over time when caring for patients diagnosed with high-grade glioma and how are these needs correlated with distress? Support Care Cancer. 2018 Jan;26(1):275-286. doi: 10.1007/s00520-017-3846-x. Epub 2017 Aug 14.

    PubMed 28808797

  • Hwang IC, Kim YS, Lee YJ, Choi YS, Hwang SW, Kim HM, Koh SJ. Factors Associated With Caregivers' Resilience in a Terminal Cancer Care Setting. Am J Hosp Palliat Care. 2018 Apr;35(4):677-683. doi: 10.1177/1049909117741110. Epub 2017 Nov 15.

    PubMed 29141459

  • Spatuzzi R, Giulietti MV, Ricciuti M, Merico F, Fabbietti P, Raucci L, Bilancia D, Cormio C, Vespa A. Exploring the associations between spiritual well-being, burden, and quality of life in family caregivers of cancer patients. Palliat Support Care. 2019 Jun;17(3):294-299. doi: 10.1017/S1478951518000160. Epub 2018 May 11.

    PubMed 29749317

  • Kobayakawa M, Ogawa A, Konno M, Kurata A, Hamano J, Morita T, Kizawa Y, Tsuneto S, Shima Y, Aoyama M, Miyashita M. Psychological and psychiatric symptoms of terminally ill patients with cancer and their family caregivers in the home-care setting: A nation-wide survey from the perspective of bereaved family members in Japan. J Psychosom Res. 2017 Dec;103:127-132. doi: 10.1016/j.jpsychores.2017.10.012. Epub 2017 Oct 23.

    PubMed 29167039

  • Roen I, Stifoss-Hanssen H, Grande G, Brenne AT, Kaasa S, Sand K, Knudsen AK. Resilience for family carers of advanced cancer patients-how can health care providers contribute? A qualitative interview study with carers. Palliat Med. 2018 Sep;32(8):1410-1418. doi: 10.1177/0269216318777656. Epub 2018 Jun 1.

    PubMed 29852808

  • Mehnert A, Lehmann C, Cao P, Koch U. [Assessment of psychosocial distress and resources in oncology--a literature review about screening measures and current developments]. Psychother Psychosom Med Psychol. 2006 Dec;56(12):462-79. doi: 10.1055/s-2006-951828. German.

    PubMed 17160791

  • Zwahlen D, Hagenbuch N, Carley MI, Recklitis CJ, Buchi S. Screening cancer patients' families with the distress thermometer (DT): a validation study. Psychooncology. 2008 Oct;17(10):959-66. doi: 10.1002/pon.1320.

    PubMed 18203146

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Downar J, Goldman R, Pinto R, Englesakis M, Adhikari NK. The "surprise question" for predicting death in seriously ill patients: a systematic review and meta-analysis. CMAJ. 2017 Apr 3;189(13):E484-E493. doi: 10.1503/cmaj.160775.

    PubMed 28385893

  • Hentschel L, Hornemann B, Schuler U, Wellesen A, Haering C, Helbig B, Janisch M, Schutte K, Langguth P. Factors associated with psychological burden among informal caregivers in outpatient palliative care: a prospective observational study of patient-caregiver dyads in Germany. BMJ Open. 2026 Jun 18;16(6):e107141. doi: 10.1136/bmjopen-2025-107141.

    PubMed 42315265

  • Hentschel L, Wellesen A, Krause LC, von Havranek M, Kramer M, Hornemann B, Bornhauser M, Schuler U, Schutte K. Predicting unplanned hospital readmission in palliative outpatients (PRePP) - study protocol of a longitudinal, prospective study to identify informal caregiver-related and structural predictors. BMC Palliat Care. 2022 May 2;21(1):62. doi: 10.1186/s12904-022-00955-y.

    PubMed 35501763

Questions about this trial

What is this clinical trial studying?

An observational study of Palliative Care, run by Technische Universität Dresden at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circumstances of Unplanned hospital admission (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05082389, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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