Contact information
Type
Scientific
Primary contact
Prof John Primrose
ORCID ID
Contact details
University Surgical Unit
University of Southampton
F Level
Centre Block (816)
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 80 796144
j.n.primrose@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/40/38
Study information
Scientific title
Acronym
Study hypothesis
To determine whether pre-operative assessment carried out by an appropriately trained nurse (ATN) is equivalent in quality to that carried out by a pre-registration house officer (PRHO).
To assess whether pre-assessments carried out by ATNs and PRHOs are equivalent in terms of cost.
To determine whether assessments carried out by ATNs are acceptable to patients.
To investigate the quality of communication between senior medical staff and ATNs.
More details can be found at: http://www.hta.ac.uk/993
Ethics approval
Not provided at time of registration.
Study design
Prospective randomised equivalence trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Pre-operative assessment
Intervention
The study design was principally a prospective randomised equivalence trial but was accompanied by additional qualitative assessment of patient and staff perceptions, and an economic evaluation.
The intervention consisted of a pre-operative assessment carried out by either an appropriately trained nurse (ATN) or a PRHO. Of the patients who completed the study with a full evaluation, 926 patients were randomised to the PRHO arm of the trial and 948 to the ATN arm. Three ATNs took part in the study, one from each centre, together with a total of 87 PRHOs.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Immediately following the initial assessment of a patient by a PRHO or an ATN, one of a number of clinical research fellows, all specialist registrars in anaesthetics, repeated the assessment and recorded it on a study form, together with a list of investigations required. The clinical research fellow then evaluated the competency of the initial assessor by comparing the quality of their assessment with their own. Any deficiencies in ordering of investigations and referral to other specialities were met in order to maximise patient care. Three areas of ATN and PRHO performance were judged separately, history taking, examination and ordering of tests, and each was graded into one of four categories, the most important of which was under-assessment, which would possibly have affected peri-operative management. In the case of ordering of tests, it was possible to have both over- and under-assessed a patient on different tests.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/10/1997
Overall trial end date
31/10/1999
Reason abandoned
Eligibility
Participant inclusion criteria
All patients attending at one site for assessment prior to general anaesthetic for elective general, vascular, urological or breast surgery were potentially included in the study. Of 1,907 patients who were randomised, 1874 completed the study with a full evaluation.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
1,907
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/10/1997
Recruitment end date
31/10/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Surgical Unit
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12468478
Publication citations
-
Results
Kinley H, Czoski-Murray C, George S, McCabe C, Primrose J, Reilly C, Wood R, Nicolson P, Healy C, Read S, Norman J, Janke E, Alhameed H, Fernandes N, Thomas E, Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial., BMJ, 2002, 325, 7376, 1323.