Condition category
Not Applicable
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
03/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zoe Fritz

ORCID ID

Contact details

Hinchingbrooke Park
Huntingdon
PE29 6NT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7932

Study information

Scientific title

Acronym

A Universal Form for Treatment Options: Development and evaluation

Study hypothesis

Our main hypothesis is that introduction of universal form for treatment options (UFTO) will remove inequities in care resulting from current approaches to do not attempt resuscitation (DNAR) (patients with DNAR forms receive substandard treatment, while other patients have resuscitation inappropriately attempted on them), and improve experience of discussions surrounding resuscitation for patient, carer, family and clinical groups (hereafter referred to as "all groups").

Our project can be divided into the following aims:

1. Finalisation of the UFTO:
This form will be filled in on every patient (the DNAR is only completed on those NOT for resuscitation), stating which specific escalations (e.g., intensive care) are appropriate (the DNAR states that one treatment, resuscitation, should be withheld). We will then assess whether the UFTO alters qualitative and quantitative outcomes in comparison to the standard DNAR form.

2. Quantitative aims:
We hypothesise the UFTO will standardise the doctors' approach to DNAR, while allowing patients' individual choices to be respected.

Ethics approval

MREC approved (ref: 09/ho310/89)

Study design

Multicentre observational process of care and treatment cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Health Services Research

Intervention

The intervention is the use of the Universal Form of Treatment Options instead of the Current DNAR form.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Outreach services

Secondary outcome measures

UFTO

Overall trial start date

01/11/2009

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. All patients admitted on weekdays
2. Assessed following the post take round, until which time usual care will have been administered

Nurses and doctors:
3. All nurses and doctors on the participating wards will be eligible for inclusion for being interviewed for the qualitative aspects of the study

Both:
4. Male and female, lower age limit of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 1080

Participant exclusion criteria

1. Those under 18 years
2. Those for palliative care only

Recruitment start date

01/11/2009

Recruitment end date

31/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hinchingbrooke Park
Huntingdon
PE29 6NT
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/

Funders

Funder type

Government

Funder name

National Insititute for Health Research (NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24023718

Publication citations

  1. Results

    Fritz Z, Malyon A, Frankau JM, Parker RA, Cohn S, Laroche CM, Palmer CR, Fuld JP, The Universal Form of Treatment Options (UFTO) as an alternative to Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) orders: a mixed methods evaluation of the effects on clinical practice and patient care., PLoS ONE, 2013, 8, 9, e70977, doi: 10.1371/journal.pone.0070977.

Additional files

Editorial Notes