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 measure
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 (if study stopped)
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
Funders
Funder type
Government
Funder name
Health Research Board
Alternative name(s)
HRB
Funding Body Type
government organisation
Funding Body Subtype
Local government
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26231755