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ISRCTN
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ISRCTN33723655
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ClinicalTrials.gov identifier
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Public title
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Multi-centre randomised controlled trial of nurse practitioners and pre-registration house officers (PRHO) in pre-operative workup
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 94/40/38
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration.
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Study design
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Prospective randomised equivalence trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pre-operative assessment
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/10/1997
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Anticipated end date
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31/10/1999
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Status of trial
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Completed
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Patient information material
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Target number of participants
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1,907
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.hta.ac.uk/993
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Publications
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2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12468478
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Contact name
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Prof
John
Primrose
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Address
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University Surgical Unit
University of Southampton
F Level, Centre Block (816)
Southampton General Hospital
Tremona Road
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Tel
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+44 (0)23 80 796144
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Fax
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+44 (0)23 80 794020
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Email
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j.n.primrose@soton.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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17/12/2008
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Date ISRCTN assigned
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25/04/2003
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