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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Wolverhampton, United Kingdom, WV3 9DH
        • Compton Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Deceased patients' notes will be reviewed from 2013 (prior to the Tracey judgement) and from 2015 (following the Tracey judgement).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Year 2013
Participant's notes will be reviewed from the year 2013
No intervention will occur
Year 2015
Participant's notes will be reviewed from the year 2015
No intervention will occur

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of DNACPR decisions
Time Frame: 1 year
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
The reasons for not discussing DNACPR decisions
Time Frame: 1 year
2) The reasons documented on DNACPR forms and in clinical notes for not discussing DNACPR decisions in 2013 and in 2015
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The documentation of the concept of 'harm' in DNACPR decisions
Time Frame: 1 year
The documentation of the concept of 'harm' in DNACPR decisions not discussed with patients in 2015
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2017

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2017PAL94

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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