Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05082389
Other study ID # BO-EK-320072020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2021
Est. completion date July 30, 2022

Study information

Verified date August 2022
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date July 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital Carl Gustav Carus Dresden Saxony

Sponsors (2)

Lead Sponsor Collaborator
Technische Universität Dresden University Hospital Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (12)

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. Review. — View Citation

Götze H, Brähler E, Gansera L, Schnabel A, Gottschalk-Fleischer A, Köhler 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. German. — View Citation

Røen 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. — View Citation

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. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Circumstances of Unplanned hospital admission Hospital admission not intended and/or planned by either professional nor non-professional care givers 18 months
Secondary Quality of Life of primary non-professional care-giver Quality of Life as assessed by WHOQOL-BREF (World Health Organization Quality of Life) 18 months
Secondary Psychological Distress of primary non-professional care-giver Psychological Distress as assessed by NCCN-Distress Thermometer 18 months
Secondary Anxiety of primary non-professional care-giver Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale 18 months
Secondary Depressivity of primary non-professional care-giver Depressivity as assessed by the Health Questionnaire depression module 9-item scale 18 months
Secondary 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 18 months
Secondary 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, 18 months
See also
  Status Clinical Trial Phase
Completed NCT04673760 - The PROAKTIV Study N/A
Completed NCT03520023 - Critical Care and Palliative Care Medicine Together in the ICU N/A
Completed NCT01990742 - Improving Palliative Care Through Teamwork N/A
Not yet recruiting NCT05434208 - Effects of Nurse-led Telephone Based Service for Early Palliative Care (PALTEL) N/A
Not yet recruiting NCT03267706 - Introducing the Palliative Care Comprehensive Tool in Family Medicine N/A
Completed NCT02845817 - Requests for Euthanasia and Assisted Suicide N/A
Recruiting NCT02778347 - Development and Validation of a Comprehensive Standardised Clinical Assessment Tool for Patient Needs N/A
Completed NCT01934413 - Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Recruiting NCT01170000 - Timely End-of-Life Communication to Parents of Children With Brain Tumors N/A
Recruiting NCT04052074 - Complementary Therapy in Home Palliative Care Patients and Their Caregivers N/A
Recruiting NCT05935540 - ACP-Family Programme for Palliative Care Patients and Their Family Member N/A
Active, not recruiting NCT02689375 - A Prospective, Open Label, Pilot Study of Patient OutcoMes Following Successful TriAl of High Frequency SpInal CorD Stimulation at 10kHz (HF10™) Leading to Permanent Implant Compared to Trial Failure and Standard CarE for the TreatmeNt of Persistent Low BACK Pain of Neuropathic Origin N/A
Recruiting NCT05520281 - Short-term Psychodynamic Psychotherapy in Serious Physical Illness N/A
Completed NCT06140004 - Home-Based Palliative Care Impact on Providers
Completed NCT04333719 - Prevalence of Deep Sedation in Terminal Palliative Phase
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I
Completed NCT06211816 - Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit N/A
Completed NCT04857060 - Palliative Care Educator N/A
Completed NCT04491110 - Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial N/A