Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001580369
Ethics application status
Approved
Date submitted
23/06/2017
Date registered
27/11/2017
Date last updated
27/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Who are they? Do patients have an understanding of the roles and experience of members of their surgical team?
Scientific title
Who are they? Do patients have an understanding of the roles and experience of members of their surgical team? Does a preoperative pamphlet distributed to patients about to undergo surgery improve their understanding of their team structure and does this improve their satisfaction.
Secondary ID [1] 291331 0
None
Universal Trial Number (UTN)
U1111-1193-6949
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient peri operative education 302317 0
Condition category
Condition code
Surgery 301899 301899 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aims

To develop and test a patient education pamphlet aimed at educating surgical patients about their surgical team makeup and about the level of experience of those doing their procedures.

Study Phase 1

We plan to distribute post procedure questionnaires to 110 post surgical patients on both the Plastics and Orthopaedic wards over a period of 4 weeks. This group of patients termed is termed the Alpha survey group.

Study Phase 2

We plan to distribute an educational pamphlet pre-operatively about the structure and roles of surgical teams to all patients on both the Plastics and Orthopaedic wards over a period of 4 weeks. Post procedure questionnaires will be distributed to 110 post surgical patients on both the Plastics and Orthopaedic wards over the same period of 4 weeks. This group of patients is termed the Beta survey group.

There will be a 2 week break between the two survey groups.

The pamphlet distributed details the make up of a surgical team, the roles of each team member, the experience of each team member and the hierarchy of the team. The pamphlet will be given to all surgical patients during the trial period regardless of wether they choose to complete the survey or not.
Intervention code [1] 297363 0
Other interventions
Comparator / control treatment
Study Phase 1

We plan to distribute post procedure questionnaires to 110 post surgical patients on both the Plastics and Orthopaedic wards over a period of 4 weeks. This group of patients termed is termed the Alpha survey group.

Study Phase 2

We plan to distribute an educational pamphlet pre-operatively about the structure and roles of surgical teams to all patients on both the Plastics and Orthopaedic wards over a period of 4 weeks. Post procedure questionnaires will be distributed to 110 post surgical patients on both the Plastics and Orthopaedic wards over the same period of 4 weeks. This group of patients is termed the Beta survey group.
Control group
Active

Outcomes
Primary outcome [1] 301334 0
Primary outcome is testing a patients satisfaction with the care they received. Patients will be asked their satisfaction level for the care they received on a scale of 1 to 5.
Timepoint [1] 301334 0
Survey will be delivered post operatively. In the intervention group the educational pamphlet will be disseminated pre operatively. Question about patient satisfaction will be in the survey. The survey will be completed whilst an inpatient prior to discharge.
Secondary outcome [1] 336307 0
A secondary outcome we will be assessing, is the knowledge patients have about their surgical team. Patients will be asked their understanding of surgical team structure, and have a scale of 1 to 5. They will also be asked various questions about the hierarchy and and make up of their surgical team.
Timepoint [1] 336307 0
Survey will be delivered post operatively. In the intervention group the educational pamphlet will be disseminated pre operatively. Questions about knowledge will be in the survey. The survey will be completed whilst an inpatient prior to discharge.

Eligibility
Key inclusion criteria
All acute patients undergoing surgery at Christchurch Public Hospital under the care of Plastics and Orthopaedic teams on Wards 18, 19 and 20 during the study period will be asked to enrol in the study. Only patients ages 16 and over are on these wards. The Study will run over a 5-week period with a 1-week hiatus between the Alpha and Beta survey groups. All patients undergoing surgery will be invited to participate, patients who cannot consent will be exclude. A paragraph detailing consent for the survey will be at the beginning of the survey.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1: Patient choice
2: Unable to consent for the survey
3: Age less than 16 years

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
One group will receive a survey to complete, the second group in a different time period will be exposed to an educational pamphlet and then receive the same survey.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This data will be presented using standard methods for statistical summaries of discrete and continuous data sets.

Standard statistical summaries (e.g. medians and ranges or means and variances, dependent on the distribution of the outcome) and graphical plots showing correlations will be presented.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2017
Actual
Date of last participant enrolment
Anticipated
28/02/2018
Actual
Date of last data collection
Anticipated
28/02/2018
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment outside Australia
Country [1] 9011 0
New Zealand
State/province [1] 9011 0
Canterbury

Funding & Sponsors
Funding source category [1] 295794 0
Self funded/Unfunded
Name [1] 295794 0
Heath Lash
Country [1] 295794 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 295803 0
None
Name [1] 295803 0
Address [1] 295803 0
Country [1] 295803 0
Other collaborator category [1] 279611 0
Individual
Name [1] 279611 0
Phil Fletcher
Address [1] 279611 0
C/O Christchurch Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country [1] 279611 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297090 0
HDEC New Zealand
Ethics committee address [1] 297090 0
Postal address
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 297090 0
New Zealand
Date submitted for ethics approval [1] 297090 0
27/02/2017
Approval date [1] 297090 0
31/10/2017
Ethics approval number [1] 297090 0
17/STH/107

Summary
Brief summary
We aim to develop and test a patient education pamphlet aimed at educating surgical patients about their surgical team makeup and about the level of experience of those doing their procedures.

We will evaluate whether information delivered in the form of a preoperative pamphlet helps patients to understand the make up of their surgical team with the hope this leads to better informed consent, more patient satisfaction and better patient understanding of their own surgical care.

The Medical Council of New Zealand states that if a ‘Student or Trainee is present during a consultation he or she should be formally introduced to the Patient’ . However, there is no current guidance on how the trainee should be introduced to help the patient identify them and understand their roll. There are also no guidelines in place for when the entire consultation, or operation, will be performed by a trainee or junior registrar, without a consultant in the room. A recent study performed at Christchurch hospital indicated that the terms used to denote seniority, i.e. house officer, registrar and consultant, are meaningless to the majority of our patients .

Previous studies in medical literature have shown that patients may decline treatment if they know a resident (junior registrar) is doing the procedure , but studies also show that general public understanding about the level of training of their doctor is poor. On top of this, studies on patients undergoing surgery have suggested that patients worry about whether the people involved in their care are appropriately trained, and feel that they want to know about their surgeons’ level of experience .

Our study plans to survey a group of patients about their knowledge of their surgical team, we then plan to introduce an educational pamphlet and repeat the survey on a second cohort of patients to see if the pamphlet improves awareness and potentially improves patient satisfaction and knowledge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72946 0
Dr Heath Lash
Address 72946 0
C/O Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 72946 0
New Zealand
Phone 72946 0
+6421585466
Fax 72946 0
Email 72946 0
[email protected]
Contact person for public queries
Name 72947 0
Dr Heath Lash
Address 72947 0
C/O Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 72947 0
New Zealand
Phone 72947 0
+6421585466
Fax 72947 0
Email 72947 0
[email protected]
Contact person for scientific queries
Name 72948 0
Dr Heath Lash
Address 72948 0
C/O Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 72948 0
New Zealand
Phone 72948 0
+6421585466
Fax 72948 0
Email 72948 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
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Documents added automatically
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