Condition category
Musculoskeletal Diseases
Date applied
16/06/2010
Date assigned
30/07/2010
Last edited
28/08/2014
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

Mr Henry Lee

ORCID ID

Contact details

Division of Surgery
Department of Surgery & Cancer
Faculty of Medicine
Imperial College London
Room 1029
10th Floor
QEQM building
St Mary's Hospital
London
W2 1NY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.1

Study information

Scientific title

The effect of cost information on patient outcomes: a randomised controlled trial

Acronym

COST

Study hypothesis

1. When patients are made aware of the financial cost of a given healthcare intervention they will be more satisfied with their care, and the treatment will have a greater positive impact on their well-being
2. The higher that the patient believes the cost of the treatment is, the greater the satisfaction and well-being derived from the intervention will be
3. The provision of cost information will also have an effect on clinical outcome (price/placebo effect)

Ethics approval

Ealing and West London Research Ethics Service, 29/12/2009, ref: 09/H0710/52

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Shoulder pain, behavioural economics

Intervention

The trial will involve randomisation of patients to three groups. Initially all participants complete the measures, as well as providing information regarding how much they think the treatment will cost. Information will then be given to participants depending on their randomisation.
1. Group one will have no information regarding the cost of treatment, simply information regarding the procedure
2. Group two will receive the information regarding the cost of the surgery according to the standardised NHS national tariff, as well as the procedure information
3. Group three will receive the cost of the information specific to the study site, which is a considerably higher cost, as well as the procedure information

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Health state (EQ5D)
2. Subjective wellbeing
3. Oxford shoulder score
Measures will be taken at enrolment, on the morning of surgery (typically 2-4 weeks after enrolment) and then again at 6 weeks following surgery.

Secondary outcome measures

Patient satisfaction measures at 6 weeks post-surgery

Overall trial start date

01/07/2010

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals undergoing primary arthroscopic shoulder decompression at the home institution
2. Informed consent in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Previous shoulder surgery on operative side
2. Unable to consent in English

Recruitment start date

01/07/2010

Recruitment end date

01/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Surgery
London
W2 1NY
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Division of Surgery
Department of Surgery & Cancer
Faculty of Medicine
Room 1029
10th Floor
QEQM building
St Mary's Hospital
London
W2 1NY
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Imperial College London (UK) - Division of Surgery (internally funded through academic institution as a small trial)

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

Publication citations

Additional files

Editorial Notes