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 measure
Outreach services
Secondary outcome measures
UFTO
Overall trial start date
01/11/2009
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24023718
Publication citations
-
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.