Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000510943
Ethics application status
Approved
Date submitted
16/05/2011
Date registered
16/05/2011
Date last updated
16/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing patient perception of the effectiveness of two methods of delivery of orthopaedic joint replacement pre admission information in a private healthcare facility.
Scientific title
To determine the efficacy of the pre admission education in fulfilling the total joint replacement patients' educational requirements and preparedness for surgery, pain managment and the post operative period from the patients' perspective.
Secondary ID [1] 533 0
Epworth Healthcare Study Number 40508
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients will have a surgery date booked for a total hip or knee joint replacement. 265860 0
Condition category
Condition code
Musculoskeletal 3106 3106 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention participants received the standard written information which consisted of the Australian Orthopaedic Association Hip or Knee Replacement Surgery, A Guide for Patients (Edition No 2, May 2008 Mitec Medical Publishing) and a preparation for joint replacement surgery booklet collated by the researcher covering the hospital stay, the episode in hospital including pain management, physiotherapy and occupational therapy roles and home aid requirements. In addition intervention participants attended a pre admission program which consisted of a two hour conference with presentations by nursing, physiotherapy and occupational therapy staff members. One on one time with a physiotherapist for individual advice and learning how to use walking aids also occurred. The intervention participants plus support person(s) also viewed a hip or knee replacement 3D multimedia patient education module. The modules were included as an adjunct to the surgical informed consent process, to reinforce information provided by the surgeon and the education program.
Intervention code [1] 2701 0
Treatment: Other
Intervention code [2] 3188 0
Other interventions
Comparator / control treatment
The control participants received the standard written informationwhich consisted of the Australian Orthopaedic Association Hip or Knee Replacement Surgery, A guide for Patients (Edition No 2, May 2008 Mitec Medical Publishing) and a a preparation for joint replacement booklet collated by the researcher covering the hospital stay, the episode in hospital including pain management, physiotherapy and occupational therapy roles and home aid requirements.
Control group
Active

Outcomes
Primary outcome [1] 3996 0
Measuring the effectiveness of the effectiveness of the pre admission education as reported by the patients by comparing the likert scale responses from the two groups. The study participants completed project specific mailed questionnaires two weeks pre operatively and prior to attending the education session for the intervention group, and at six week post operatively.
Timepoint [1] 3996 0
Pre operatively, did the participants believe they had enough pre operative information and were prepared for surgery.
Primary outcome [2] 4512 0
Did the particiants in retrospect feel they were prepared for surgery, did they feel the pre admission information prepared them for the management of their post operative pain?
Timepoint [2] 4512 0
Post operatively, via the six week post operative questionnaire. .
Secondary outcome [1] 6728 0
Comparison of the intervention and control group participants' in-patient length of stay.
Timepoint [1] 6728 0
Post discharge.
Secondary outcome [2] 6729 0
Patient complaints as registerd on the hospital Riskman database.
Timepoint [2] 6729 0
Up to three months after discharge.

Eligibility
Key inclusion criteria
Patients must be over 18 years of age, able to read and write English and not have a visual, hearing or cognitive impairment. Participants will be scheduled for hip or knee replacement surgery at Epworth Richmond or Eastern campus's. Participants will all receive the standard hospital education pack from their surgeon. Participants will be matched by gender, age (within 10 years), hip or knee surgery, previous surgery and previous orthopaedic surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are not scheduled for total hip or knee repalcement surgery at Epworth Richmond or Eastern sites,are under 18 years of age , who are unable to read or write English or have a visual, hearing or cognitive impairment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was nor concealed. Patients to be admitted to Epworth Richmond were allocated to the Intervention and those booked for surgery at Epworth Eastern were allocated to the Control Group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257835 0
Hospital
Name [1] 257835 0
Epworth HealthCare
Country [1] 257835 0
Australia
Primary sponsor type
Hospital
Name
Epworth HealthCare
Address
89 Bridge Road
Richmond
Victoria
3121
Country
Australia
Secondary sponsor category [1] 257037 0
None
Name [1] 257037 0
Address [1] 257037 0
Country [1] 257037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259866 0
Epworth Healthcare
Ethics committee address [1] 259866 0
Ethics committee country [1] 259866 0
Australia
Date submitted for ethics approval [1] 259866 0
05/03/2008
Approval date [1] 259866 0
12/03/2008
Ethics approval number [1] 259866 0
40408

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28469 0
Address 28469 0
Country 28469 0
Phone 28469 0
Fax 28469 0
Email 28469 0
Contact person for public queries
Name 11626 0
Karren Ekberg
Address 11626 0
Musculoskeletal Research Centre
Suite 1.0
89 Bridge Road
Richmond
Victoria
3121
Country 11626 0
Australia
Phone 11626 0
+61 3 9426 8500
Fax 11626 0
+61 3 9426 8492
Email 11626 0
[email protected]
Contact person for scientific queries
Name 2554 0
Karren Ekberg
Address 2554 0
Epworth HealthCare
89 Bridge Road
Richmond
Victoria
3121
Country 2554 0
Australia
Phone 2554 0
+61 3 94268500
Fax 2554 0
+61 3 94268492
Email 2554 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.