How is the Term 'Harm' Being Interpreted and Documented o... | NCT03195725

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

NCT03195725

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Status

Completed

Last Update Posted

Jun 19, 2019Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Cardiopulmonary Resuscitation

Interventions

Review of notes

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2017Actual

Primary Completion Date

Oct 31, 2018Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Jun 20, 2017

First Submission Date that Met QC Criteria

Jun 20, 2017

First Posted Date

Jun 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2019

Last Update Posted Date

Jun 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Year 2013		Participant's notes will be reviewed from the year 2013	Other: Review of notes
Year 2015		Participant's notes will be reviewed from the year 2015	Other: Review of notes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Review of notes	Other	No intervention will occur	Year 2013 Year 2015

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Compton Hospice		Wolverhampton		WV3 9DH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided