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NCT03195725 Clinical Trial

How is the Term 'Harm' Being Interpreted and Documented on Hospice DNACPR Forms Following the Tracey Judgement?

Cardiopulmonary Resuscitation Clinical Trial

Official title:
How is the Term 'Harm' Being Interpreted and Documented on Hospice DNACPR Forms Following the Tracey Judgement?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03195725
Other study ID # 2017PAL94
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 24, 2017
Est. completion date October 31, 2018

Study information
Verified date June 2019
Source The Royal Wolverhampton Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate how discussions surrounding Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) decisions have changed following the Tracey judgement and how "harm" is being defined by clinicians working within specialist palliative care in a hospice setting.

Description:

This is a retrospective case note review. Five hospices within the West Midlands will be invited to participate and up to 300 sets of deceased patients' notes containing a DNACPR form will be reviewed; 150 from 2013 (prior to the Tracey judgement) and 150 from 2015 (following the Tracey judgement).

Initially these forms will be reviewed to document the percentage of patients with whom a DNACPR decision was discussed in 2013 and the percentage with whom it was discussed in 2015 to allow comparison from before the Tracey judgement and after the Tracey judgement.

If patients did NOT have DNACPR decisions discussed with them, their DNACPR forms and clinical notes will then be reviewed and the reasons documented for not involving patients in 2013 and in 2015 compared. It is anticipated that many, if not most, DNACPR decisions which were not discussed with patients in 2013 will cite "distress" as the reason but following the Tracey judgement this would not be acceptable in 2015.

Further analysis of DNACPR forms and clinical notes will then take place for those patients identified as not being involved in DNACPR discussions in 2015 (post-Tracey) to identify whether, and how, "harm" was defined by the clinician. This should be recorded on the DNACPR form or in the clinical notes.

Following data collection, quantitative analysis will be undertaken to allow comparison of percentages of DNACPR decisions discussed with patients in 2013 and 2015 followed by descriptive analysis of variation in reasons for not discussing DNACPR decisions in 2013 and 2015. This study is explorative in nature and further qualitative analysis will not be part of this research project.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who died in 2013 or 2015 known to the individual hospice team (in-patient unit, day unit or community team)

- Completed DNACPR form within the clinical notes which was completed in 2013 or 2015

Exclusion Criteria:

- No completed DNACPR form within the clinical notes

- DNACPR form not completed in 2013 or 2015

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Review of notes
No intervention will occur

Locations
Country Name City State
United Kingdom Compton Hospice Wolverhampton

Sponsors (1)
Lead Sponsor Collaborator
The Royal Wolverhampton Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of DNACPR decisions 1) The number of DNACPR decisions which were discussed with patients in 2013 (prior to the Tracey judgement) and in 2015 (following the Tracey judgement) 1 year
Primary The reasons for not discussing DNACPR decisions 2) The reasons documented on DNACPR forms and in clinical notes for not discussing DNACPR decisions in 2013 and in 2015 1 year
Secondary The documentation of the concept of 'harm' in DNACPR decisions The documentation of the concept of 'harm' in DNACPR decisions not discussed with patients in 2015 1 year
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