Condition category
Musculoskeletal Diseases
Date applied
17/06/2011
Date assigned
28/07/2011
Last edited
12/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
All patients in England who are having hip replacement surgery are invited to complete a Patient Reported Outcome Measures (PROMs) questionnaire before and six months after their operation. The NHS in England developed this initiative in order to improve the quality of the care that it provides. In Ireland, surgeons’ performance data lacks both the patients’ view and outcome measures. The aim of this study is to find out whether collecting patient-reported outcomes from hip replacement patients and feeding the results back to surgeons is effective at improving patient outcomes.

Who can participate?
Orthopaedic surgeons and patients aged over 18 undergoing hip replacement surgery

What does the study involve?
Patients are asked to complete a questionnaire before and six months after their hip replacement surgery. Surgeons are randomly allocated to one of three groups. The first group receives no feedback on outcome scores. The second group receives feedback and an educational session covering interpretation of the data. The third group receives the same as the second group but with additional information to improve their interpretation of the data.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. AMNCH, Tallaght
2. Cappagh National Orthopaedic Hospital, Dublin
3. St. Mary’s Orthopaedic Hospital, Cork
4. Croom Regional Orthopaedic Hospital, Limerick
5. Lourdes Orthopaedic Hospital, Kilkenny
6. Our Lady‘s Hospital, Navan
7. Tullamore Regional Hospital, Offaly
8. Merlin Park Regional Hospital, Galway
9. Bon Secours Hospital, Cork
10. Bon Secours Hospital, Dublin
11. Bon Secours Hospital, Galway
12. Blackrock Clinic, Dublin
13. Hermitage Medical Clinic, Dublin
14. Sports Surgery Clinic, Dublin
15. The Beacon Medical Clinic, Dublin

When is the study starting and how long is it expected to run for?
April 2011 to May 2013

Who is funding the study?
The Health Research Board (Ireland)

Who is the main contact?
Prof. John Browne
J.Browne@ucc.ie

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Browne

ORCID ID

Contact details

Dept. of Epidemiology and Public Health
Brookfield Health Sciences Complex
University College Cork
Cork
N/A
Ireland
+353 (0)21 490 1598
J.Browne@ucc.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does providing patient-reported outcome feedback to orthopaedic surgeons improve outcomes for patients undergoing hip replacement surgery compared to providing no feedback? A cluster randomised controlled trial

Acronym

PROFILE

Study hypothesis

PROFILE (Patient Reported Outcomes: Feedback, Interpretation and Learning Experiment)
1. Providing feedback with benchmarking of PROMs data to surgeons will improve outcomes for patients undergoing hip replacement surgery.
2. Using methods to improve the interpretability of PROMs will further improve outcomes for patients undergoing hip replacement surgery.

Ethics approval

Clinical Research Ethics Committee, University College Cork, 07/12/2010

Study design

Multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Osteoarthritis/primary hip replacement surgery

Intervention

Participating surgeons will be randomly assigned by an independent person who has no patient or physician contact to one of three groups using a computer generated list of random permuted blocks of numbers. The three arms of the trial are:

1. No feedback on outcome scores (control group).
2. Feedback plus educational session covering benchmarking and interpretation of data (intervention group 1)
3. As intervention group 1 but with additional use of Rasch analysis to improve interpretability of the data (Intervention group 2)

Blinding of surgeons will not be possible, however blinding of patients and those carrying out statistical analyses will be used.

This study will involve a quality improvement package based upon PROMs including a feedback report and an educational session. The type of feedback report will depend on the intervention group and will contain personalised PROMs data for each surgeon. The feedback will be benchmarked against UK PROM data and anonymous Irish peer data to eliminate contamination and confidentiality issues. The educational session will be provided to the intervention groups and will describe the content, scoring and interpretation of the PROMs data. Intervention group 2 will be provided with additional information regarding Rasch analysis.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The Oxford hip score. It is widely used specific instrument to estimate outcomes after hip replacement. It has shown to be responsive to change and is the disease-specific instrument used in the UK PROMs programme. This data will be captured before the operation and at six months after the operation.

Secondary outcome measures

1. The EQ-5D score
2. The Hip Osteoarthritis Outcome Score
3. Surgical complication rate
Measured before the operation and at six months after the operation

Overall trial start date

01/04/2011

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Surgeon:
High volume hip replacement surgeons (defined as at least two primary, unilateral, elective hip replacement operations per week)

Patient:
1. Aged over 18
2. Undergoing primary, unilateral, elective hip replacement surgery
3. Public and private patients

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

27 surgeons and 1,350 patients

Participant exclusion criteria

Surgeon:
1. Low volume hip replacement surgeons
2. Near retirement (in next 2 years)

Patient:
1. Aged under 18
2. Undergoing a bilateral or revision hip replacement
3. Surgery due to trauma
4. Unable to complete a written questionnaire in English be it due to: cognitive impairment, literacy or language comprehension

Recruitment start date

01/04/2011

Recruitment end date

31/05/2013

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Cork
Cork
N/A
Ireland

Sponsor information

Organisation

The Health Research Board (Ireland)

Sponsor details

73 Lower Baggot St
Dublin
N/A
Ireland

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Health Research Board

Alternative name(s)

HRB

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Ireland

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26231755

Publication citations

Additional files

Editorial Notes

12/08/2016: Plain English summary added.