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
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 |
|---|---|
| j.n.primrose@soton.ac.uk |
Study information
| Study design | Prospective randomised equivalence trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/10/1997 |
| Completion date | 31/10/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 1,907 |
| 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
- England
- United Kingdom
Study participating centre
University Surgical Unit
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
