Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195725
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Brief 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.

Condition or disease Intervention/treatment
Cardiopulmonary Resuscitation Other: Review of notes

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: How is the Term 'Harm' Being Interpreted and Documented on Hospice DNACPR Forms Following the Tracey Judgement?
Actual Study Start Date : July 24, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR Hospice Care

Group/Cohort Intervention/treatment
Year 2013
Participant's notes will be reviewed from the year 2013
Other: Review of notes
No intervention will occur

Year 2015
Participant's notes will be reviewed from the year 2015
Other: Review of notes
No intervention will occur




Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195725


Locations
Layout table for location information
United Kingdom
Compton Hospice
Wolverhampton, United Kingdom, WV3 9DH
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust

Layout table for additonal information
Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03195725     History of Changes
Other Study ID Numbers: 2017PAL94
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No