Multi-centre randomised controlled trial of nurse practitioners and pre-registration house officers (PRHO) in pre-operative workup

ISRCTN	ISRCTN33723655
DOI	https://doi.org/10.1186/ISRCTN33723655
Protocol serial number	HTA 94/40/38
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 11/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Primrose
Scientific

University Surgical Unit
University of Southampton
F Level, Centre Block (816)
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)23 80 796144
Email	j.n.primrose@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Prospective randomised equivalence trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	31/10/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	1907
Key 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.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/10/1997
Date of final enrolment	31/10/1999

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University Surgical Unit

Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/12/2002		Yes	No