Condition category
Not Applicable
Date applied
07/07/2020
Date assigned
13/08/2020
Last edited
13/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

There is increasing evidence that the main factor for variability in end of life decision making (ELDM) in intensive care units is caused by the individual provider. Although end of life decisions are often complex and should be adapted to every single patient and situation, provider-caused variability is problematic as it may cause unequal care that affects patient outcomes. The primary aim of this study was to investigate contributing factors behind provider-caused variability in ELDM.

This is a qualitative sub-study of a previously conducted interview study. In-depth thematic analyses of semi-structured interviews with 19 critical care specialists from 5 different Swedish intensive care units (ICU's) were performed. Interviews took place between February 1st 2017 to May 31st, 2017.

Timing and decisiveness in ELDM vary with the physician's personality as well as professional and personal experiences. Many of the respondents were aware they might be affected by prejudices and values in ELDM. Respondents did not think that their own religious beliefs played any part in ELDM.
Respondents expressed they dreaded to be regarded as careless or ill-advised, and conflicts and criticism were described as emotionally draining and were therefore avoided. Junior consultants were more inclined to acknowledge that lack of personal and organisational resources influences ELDM, whereas senior consultants stressed that these factors did not affect the ELDM.

Background and study aims
To make end-of-life (EOL) decisions is a complex and challenging task for intensive care physicians and a substantial variability in this process has been previously reported. However, a deeper understanding of intensivists’ experiences and attitudes regarding the decision-making process is still, to a large extent, lacking. The primary aim of this study was to address Swedish intensivists’ experiences, beliefs and attitudes regarding decision-making pertaining to EOL decisions and to identify underlying factors that may contribute to variability in the decision-making process.

Who can participate?
Swedish consultants who actively practice in critical-care units

What does the study involve?
Face to face interviews with critical-care consultants in 5 different hospitals in Sweden

What are the possible benefits and risks of participating?
For a specific person participating in our study there should be very little risk to harm. benefits are to express ones understanding of making these difficult and complex decisions.

Where is the study run from?
The Sahlgrenska University Hospital, Gothenburg, (Sweden)


When is the study starting and how long is it expected to run for?
From February 2017 to May 2017

Who is funding the study?
This study was financed by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF agreement (ALFGBG-772521, ALFGBG-722301) and the Healthcare Board, Region Västra Götaland, (VGFOUREG-833561). The Gothenburg Society of Medicine (GLS-884181) Swedish Medical Society (SLS-930544).

Who is the main contact?
alma.syrous@vgregion.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alma Nordenskjöld Syrous

ORCID ID

https://orcid.org/0000-0002-8599-204X

Contact details

c/o Block
Blå stråket 5
Sahlgrenska universitetssjukhuset
Gothenburg
41345
Sweden
+46 (0)735344214
alma.syrous@vgregion.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Reasons for provider-caused variability in end-of-life decision-making in intensive care

Acronym

Study hypothesis

To investigate contributing factors behind provider-caused variability in end of life decision making (ELDM) in intensive care units.

Ethics approval

Approved 04/03/2013, the Authority for ethical approvement Etikprövningsmyndigheten (Box 2110, 750 02 Uppsala, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: Dnr 616‐16

Study design

Qualitative sub-study of a previously conducted interview study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

End of life decisions in ICU

Intervention

In-depth thematic analyses of semi-structured interviews with 19 critical care specialists from five different Swedish intensive care units (ICUs) are performed. Interviews take place between February 1st 2017 and May 31st 2017. Data collected included freely expressed reflections on beliefs and experiences of each consultant about decision-making in end-of-life care. No follow-up was planned or performed.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Factors that gives variation to Swedish intensivists’ experience in decisions in end-of-life care freely expressed reflections on beliefs and experiences of consultants about decision-making in end-of-life care in face to face semi-structured interviews in 2017

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/04/2017

Overall trial end date

30/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Consultants working in the ICU of the participating centre

Participant type

Health professional

Age group

Mixed

Gender

Both

Target number of participants

19

Total final enrolment

19

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/04/2017

Recruitment end date

30/05/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Hallands sjukhus Vargberg
Varberg
43237
Sweden

Trial participating centre

Helsingborgs lasarett
Helsingborg
25223
Sweden

Trial participating centre

NÄL
Trollhättan
46173
Sweden

Trial participating centre

Universitets sjukhuset i Linköping
Linköping
58185
Sweden

Trial participating centre

Norrlands universitets sjukhus Umeå
Umeå
90737
Sweden

Sponsor information

Organisation

University of Gothenburg

Sponsor details

Box 100
Gothenburg
40530
Sweden
+46 (0)31 786 10 00
registrator@gu.se

Sponsor type

University/education

Website

http://www.gu.se/english

Funders

Funder type

Government

Funder name

Healthcare Board, Region Västra Götaland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish government and the county councils

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Gothenburg Society of Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers would like to publish in Critical Care.

IPD sharing statement:
All data was anonymized. All respondents in the qualitative studies get verbal and written information and signed consent. Data is kept at Sahlgrenska University hospital and are available on request to linda.block@vgregion.se

Intention to publish date

01/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/08/2020: Trial’s existence confirmed by Regionala Etikprövningsnämnden i Göteborg.