- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05082389
Prediction of Hospital Readmissions in SAPV (Specialised Home Palliative Care) Patients (PRePP)
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
- Identification of structural predictors and caregiver reported predictors for hospital readmissions.
- Identification of psychological liabilities of nursing relatives.
- Developing a concept to support nursing relatives.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Saxony
-
Dresden, Saxony, Germany, 01307
- University Hospital Carl Gustav Carus
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circumstances of Unplanned hospital admission
Time Frame: 18 months
|
Hospital admission not intended and/or planned by either professional nor non-professional care givers
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
18 months
|
Psychological Distress of primary non-professional care-giver
Time Frame: 18 months
|
Psychological Distress as assessed by NCCN-Distress Thermometer
|
18 months
|
Anxiety of primary non-professional care-giver
Time Frame: 18 months
|
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
|
18 months
|
Depressivity of primary non-professional care-giver
Time Frame: 18 months
|
Depressivity as assessed by the Health Questionnaire depression module 9-item scale
|
18 months
|
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
|
18 months
|
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,
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katharina Schütte, MD, University Hospital Dresden; Palliative Care Unit
- Principal Investigator: Leopold Hentschel, Dipl.-Psych., University Hospital Dresden; Department of Psychooncology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BO-EK-320072020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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