Condition category
Digestive System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
13/02/2009
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 Williams

ORCID ID

Contact details

University of Wales Swansea
Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 513402
j.g.williams@swan.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 97/37/09

Study information

Scientific title

Acronym

MINuET

Study hypothesis

The project will evaluate the acceptability, effectiveness, outcome and cost of upper and lower gastrointestinal endoscopy undertaken by nurses in hospital. We plan to compare:
1. The acceptability to patients of these procedures when undertaken by nurses or doctors
2. The quality of the process of these procedures when undertaken by nurses or doctors
3. The outcome for, and value to, patients of these procedures when undertaken by nurses or doctors
4. The resources consumed by the NHS and patients through these procedures when undertaken by nurses or doctors.

We also plan to develop an economic model to predict the effect of nurse endoscopies on the labour market and training requirements for clinical nurse specialists.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Digestive system diseases

Intervention

Endoscopy undertaken by nurses versus doctors

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Acceptability and anxiety scores, completeness of examination, incidence of technical complications, recording of clinical findings, and need for further investigation or procedure.
2. Incidence of clinical complications, quality of life (generic and disease-specific) measured pre-procedure and at one and 12 months post-procedure.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

31/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing upper and lower gastrointestinal (GI) endoscopy.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1888

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2001

Recruitment end date

31/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Wales Swansea
Swansea
SA2 8PP
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

1. 2006 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/17018229
2. 2009 clinical effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/19208714
3. 2009 cost efectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/19208715

Publication citations

  1. HTA monograph

    Williams J, Russell I, Durai D, Cheung WY, Farrin A, Bloor K, Coulton S, Richardson G, What are the clinical outcome and cost-effectiveness of endoscopy undertaken by nurses when compared with doctors? A Multi-Institution Nurse Endoscopy Trial (MINuET)., Health Technol Assess, 2006, 10, 40, iii-iv, ix-x, 1-195.

  2. Clinical effectiveness results

    Williams J, Russell I, Durai D, Cheung WY, Farrin A, Bloor K, Coulton S, Richardson G, Effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET)., BMJ, 2009, 338, b231.

  3. Cost efectiveness results

    Richardson G, Bloor K, Williams J, Russell I, Durai D, Cheung WY, Farrin A, Coulton S, Cost effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET)., BMJ, 2009, 338, b270.

Additional files

Editorial Notes