Condition category
Surgery
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
11/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes