Submission date
16/06/2010
Registration date
30/07/2010
Last edited
18/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Retrospectively registered
? Protocol not yet added
? SAP not yet added
? Results not yet added and study completed for more than 2 years
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

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/CTIS number

IRAS 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(s)

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

Study setting(s)

Hospital

Study type

Other

Patient information sheet

Not available in web format, please use the contact details 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

Primary outcome measure

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 study start date

01/07/2010

Overall study end date

01/07/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type(s)

Patient

Age group

Adult

Sex

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

England, United Kingdom

Study participating centre

Imperial College London
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
England
United Kingdom

Sponsor type

University/education

Website

ROR

https://ror.org/041kmwe10

Funders

Funder type

Hospital/treatment centre

Funder name

Imperial College London

Alternative name(s)

Imperial College of Science, Technology and Medicine, Imperial College London in United Kingdom, imperialcollege, Imperial College London, UK, Imperial College London, London, England, ICL

Funding Body Type

government organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes

18/04/2017: No publications found, verifying study status with principal investigator.