Trial document

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DRKS-ID: DRKS00025405

Trial Description

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Title

Dying in Hospital – Optimization of care in the dying phase

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Trial Acronym

StiK-OV

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URL of the Trial

https://palliativzentrum.uk-koeln.de/forschung/letzte-lebenszeit/sterben-im-krankenhaus/

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Brief Summary in Lay Language

Hospitals are the most frequent place of death in Germany with 47%, and at the same time dissatisfaction with the dying phase is greatest here. Essential quality indicators of good end-of-life care already exist and proposals for achieving this goal are available.
This project aims to optimise the care and support of dying patients and their relatives in hospital by means of easy-to-implement measures appropriate to the situation.
The project is being carried out at the University Hospital of Cologne and the University Hospital of Hamburg-Eppendorf and comprises three phases:
In the first phase, experience is gathered on measures and a portfolio of measures for optimal end-of-life care is created.
In the second phase, the dying situation on ten wards of the two university hospitals is surveyed by means of file analysis of deceased persons, a staff survey, interviews with relatives and group interviews with staff. The portfolio of measures and the results of the status survey are presented to the wards. Subsequently, ward-specific working groups select measures from the portfolio that are appropriate to the situation and context and apply them in everyday clinical practice. Then the death situation is surveyed again and compared with the basic data.
In the third phase, the project results obtained are reviewed and published with regard to their transferability to other hospitals.

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Brief Summary in Scientific Language

Hospitals are the most frequent place of death in Germany with 47%, and at the same time dissatisfaction with the dying phase is greatest here. Essential quality indicators and outcomes of good end-of-life care have already been consulted and proposals for achieving this goal have been formulated.
The present project, funded by the Innovation Fund (duration: 11/2020 - 10/2023), aims to optimise the care and support of dying patients and their relatives in hospital by means of easy-to-implement measures appropriate to the situation.
The project is being carried out at the University Hospital Cologne (UKK) and the University Hospital Hamburg-Eppendorf (UKE) and comprises three phases:
1) First, existing experiences on measures are collected and a portfolio of measures for optimal end-of-life care is created.
2) Subsequently, the dying situation on ten wards of the two university hospitals is surveyed by means of retrospective file analysis of deceased persons, a quantitative staff survey, interviews with relatives and multi-professional focus groups. The portfolio of measures and the results of the status survey are presented to the wards. Subsequently, ward-specific working groups select measures from the portfolio that are appropriate to their situation and context and apply them in everyday clinical practice. Then the death situation is surveyed again and compared with the baseline data.
3) Finally, the project results obtained are reviewed and published with regard to their transferability to other hospitals.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

[---]*

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Organizational Data

DRKS-ID: DRKS00025405
Date of Registration in DRKS: 2021/06/17
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 20-1727, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln

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Secondary IDs

[---]*

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Health Condition or Problem studied

Free text: Dying situation in hospital

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Interventions/Observational Groups

Arm 1: Ward teams:
1) On the ten wards of the two university hospitals, quantitative online staff surveys will be conducted on measures concerning care in the dying phase.
2) Focus groups on these measures and their assessment are conducted on the wards.
3) The ward team selects measures from a set of measures and implements them throughout the ward.

Patient files:
The files of patients who have died on the wards are analysed by ward staff.

Relatives of deceased:
Qualitative interviews are conducted with relatives of patients who have died on the wards.

(Inter-) national experts:
Implementation of hybrid symposia

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Health care system
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

Optimising the care and support of dying people and their relatives in hospital.

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Secondary Outcome

1) Generation of data on the acceptance and effectiveness of measures to optimise the dying phase in terms of a "minimally invasive" approach among patients, relatives and care teams.
2) Establishment of a broad portfolio of measures ("toolbox") of possible measures to optimise care in the dying phase and sustainable publication, e.g. on the website of the German Society for Palliative Medicine (DGP).
3) Consensus on a generic concept for optimising care in the dying phase by an advisory board for adoption by other hospitals.

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center Köln
University Medical Center Hamburg

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2021/08/01
Target Sample Size: 200
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

Wards:
The selection of the ten wards of the two university hospitals is based on purposeful sampling and the following criteria:
- Qualification of the staff
- Ward setting, speciality
- size of ward
- Number of deaths
The aim is to provide a comprehensive picture of the conditions on the wards through the greatest possible heterogeneity.

Relatives:
- Relatives of patients who died on one of the selected wards.
- ≥18 years
- Written consent to participate
- Sufficient knowledge of the German language, both written and spoken

Ward staff:
- Working on one of the selected wards with direct patient contact (e.g. medical or nursing care)
- ≥18 years

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Exclusion Criteria

Relatives:
No sufficient knowledge of German

Ward staff:
Work on one of the selected wards without direct patient contact

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Addresses

Primary Sponsor
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- Zentrum für Palliativmedizin, Uniklinik Köln
- Kerpener Str. 62
- 50937 Köln
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Zentrum für Palliativmedizin
- Ms. Dr. Kerstin Kremeike
- Kerpener Str. 62
- 50937 Köln
- Germany
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- Telephone: 022147887835
- Fax: 02214781434808
- E-mail: kerstin.kremeike at uk-koeln.de
- URL: https://palliativzentrum.uk-koeln.de/
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Contact for Public Queries
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- Zentrum für Palliativmedizin
- Ms. Kerstin Kremeike
- Kerpener Str. 62
- 50937 Köln
- Germany
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- Telephone: 022147887835
- Fax: 0221478434808
- E-mail: leonie.weyres at uk-koeln.de
- URL: https://palliativzentrum.uk-koeln.de/
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Innovationsausschuss beim Gemeinsamen Bundesausschuss
- Gutenbergstraße 13
- 10587 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: info at if.g-ba.de
- URL: https://innovationsfonds.g-ba.de/
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Status

Recruitment Status: Recruiting ongoing
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): [---]*
Number of Participants in Germany after Recruiting complete: [---]*
Total Number of Participants (all Sites worldwide) after Recruiting complete: [---]*

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Trial Publications, Results and other Documents

trial protocol (mandatory for transfer to Studybox): Kremeike K, Ullrich A, Schulz H, Rosendahl C, Boström K, Kaur S, Oubaid N, Plathe-Ignatz C, Leminski C, Hower K, Pfaff H, Hellmich M, Oechsle K, Voltz R. Dying in hospital in Germany - optimising care in the dying phase: study protocol for a multi-centre bottom-up intervention on ward level. BMC Palliat Care. 2022 May 6;21(1):67. doi: 10.1186/s12904-022-00960-1. PMID: 35524257; PMCID: PMC9072764.

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* This entry means the parameter is not applicable or has not been set.