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
Secondary identifying numbers HTA 94/40/38
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

Study designProspective randomised equivalence trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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) studiedPre-operative assessment
InterventionThe 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 typeProcedure/Surgery
Primary outcome measureImmediately 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 measuresNot provided at time of registration.
Overall study start date01/10/1997
Completion date31/10/1999

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants1,907
Key inclusion criteriaAll 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 criteriaNot provided at time of registration.
Date of first enrolment01/10/1997
Date of final enrolment31/10/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Surgical Unit
Southampton
SO16 6YD
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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