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
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
-
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.
-
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.
-
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.