ANZCTR - Registration

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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]

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

Condition category

Condition code

Surgery

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]

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]

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]

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]

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]

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?

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]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Heath Lash

Address [1]

C/O Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Christchurch Hospital

Address

Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Phil Fletcher

Address [1]

C/O Christchurch Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDEC New Zealand

Ethics committee address [1]

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]

New Zealand

Date submitted for ethics approval [1]

27/02/2017

Approval date [1]

31/10/2017

Ethics approval number [1]

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

Dr Heath Lash

Address

C/O Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+6421585466

Fax

nzheath@hotmail.com

Contact person for public queries

Name

Heath Lash

Address

C/O Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+6421585466

Fax

nzheath@hotmail.com

Contact person for scientific queries

Name

Heath Lash

Address

C/O Orthopaedic Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+6421585466

Fax

nzheath@hotmail.com

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.

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