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Trial registered on ANZCTR


Registration number
ACTRN12614000593639
Ethics application status
Approved
Date submitted
28/05/2014
Date registered
4/06/2014
Date last updated
29/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the engagement of patients suffering from wisdom tooth problems in shared clinical decision making using different formats of health information toward achieving better healthcare outcomes.
Scientific title
The Impact of Guiding Patients Suffering from Wisdom Tooth Problems through Dental Open Educational Resources (DOER) on Enhancing Shared Clinical Decision-Making and Improving Health Care Outcomes: A Randomized Controlled Trial.
Secondary ID [1] 284671 0
Nil
Universal Trial Number (UTN)
U1111-1157-3828
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wisdom tooth problems 292010 0
Condition category
Condition code
Oral and Gastrointestinal 292356 292356 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group (study group):
Participants of this group will receive a list of recommended Dental Open Educational Resources as an additional resources for patient educational materials one month before consultation. Participants can access these information at any time as they are freely accessable online. Knowledge and anexiety will be assessed in pre-consultation survey. Patient participation in shared decision making,, satisfaction and quality of life will be evaluated post intervention pre-consultation and at one month post consultation/ surgery. via a survey thatwill be posted to them. In the pre-consultation survey, participants will be asked if they reviewed the provided resources. A sample of 25 participants will be invited for structured interview that will take place face to face, online, over the phone depending on patient preference.
Intervention code [1] 289456 0
Other interventions
Comparator / control treatment
Control group:
Participants will receive standard care patient education (verbal communication and information leaflets) at consultation. At consultation participants will be requested to fill in a pre-consultation survey to assess their knowledge and anxiety. Patient participation in shared decision making, satisfaction and quality of life will be evaluated through a one month post consultation/ surgery survey that will be conducted either online or by post depending on patient preference.
Control group
Active

Outcomes
Primary outcome [1] 292270 0
1.Engagement in shared clinical decision-making using dyadic SDM-Q-9 for patients and SDM--9-Doc for clinicians
Timepoint [1] 292270 0
At consultation:
1. For patient: using SDM-9Q for patients of consultation survey.
2. For Clinicians: using SDM-Doc of clinician’s survey.
Primary outcome [2] 292271 0
2.Oral and general heath related QoL using OHIP-14 and EuroQol-5D-5L.
Timepoint [2] 292271 0
At baseline (one month before consultation) to get a baseline estimate and on follow-up servey (one month after consultation/ surgical removal).
Secondary outcome [1] 308596 0
1.Patient knowledge measured using wisdom tooth quiz which was designed specifically for this study.
Timepoint [1] 308596 0
At baseline (one month before consultation) and at Pre-consultation (in waiting room before consultation).
Secondary outcome [2] 308597 0
2.Anxiety levels using IDAF-4C.
Timepoint [2] 308597 0
At baseline (one month before consultation) and at Pre-consultation (in waiting room before consultation).
Secondary outcome [3] 308598 0
3. Satisfaction using the satisfaction scale which was designed specifically for this study.
Timepoint [3] 308598 0
At baseline (one month before consultation) and At follow-up (one month after consultation/ surgical removal)
Secondary outcome [4] 308599 0
4. Gap between the preferred decisional role and actual decision experience using decisional role preference scale.
Timepoint [4] 308599 0
At baseline (one month before consultation) and at consultation using consultation survey (after consultation section) that will be completed immediately after consultation and handed to the receptionest..
Secondary outcome [5] 308600 0
5. Decision outcomes: difference between number of teeth refered for extraction and teeth decided to be extracted, treatment pathway and anaesthetic option.
Timepoint [5] 308600 0
Clinican's survey (at consultation).

Eligibility
Key inclusion criteria
Participants who have been diagnosed with wisdom teeth problems otherwise fit and healthy, aged 18-39 years, internet users, signed the informed consent
Minimum age
18 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
non internet user, have serious health problems, non English speakers.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study subjects will be recruited from patients referred for wisdom teeth removal at Adelaide Dental Hospital and East Adelaide Oral and Maxillofacial Clinic. Using patient referral information, participant will be approached by the unit secretary who is normally have an access to patients details providing the eligible participants with the study information sheet, consent form, baseline survey. One the reciept of the signed consent form and the baseline survey a decision will be made by the researcher either to include or exclude from the study. The included participants then will be randomly allocated to either study or control group using a computerized variable block randomization by the researcher. Allocation is not concealed to the researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Equal arm variable block randomization with random seed using radomization.com website. After participants were found to be eligible for inclusion in the study, each participant is provided with a sequential number that is continuous for the study. Depending on the flow of received baseline survey and the signed consent form, a randomization plan is generated from this website when an even number of participants was available: 2, 4, 6..... Each generated randomization plan is has the participant's continuous sequential number, the randomly allocated group, randomization date and time and seed number saved This method allows for blindness the researcher to participants random allocation and no need for an independent person to carry out the randomization.
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
Descriptives, correlations, t-test, linear regression, logit regression.

Sample size calculation
Each group will consist of 250 participants , This calculation was based on the mean of OHIP scores of Australian population survey is 5.82 (SD=8.59). In a recent study carried out by Brennan (2013) and minimum important difference of OHIP 5-point scale (Locker et al., 2004) will generate a sample size of n=47 per group based on alpha 0.05 and power of 80%. However Brennan et al. (2012) have reported that, 25% of persons have reported worsening in their oral health mainly due to dental extractions. This will require multiplying the sample by four times resulting in a sample size of (n+188 per group).
As some of our study participants may not undergo surgical extraction because of a shared clinical decision-making, this will require inflation of sample size to compensate for this percentage or recruit until sample yield is achieved. In addition, this sample size is exceeds the required sample size for using EuroQoL-5D as treatment outcomes variable (Roset, 1999).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/06/2014
Actual
15/09/2014
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2502 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8149 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289297 0
University
Name [1] 289297 0
Australian Research Centre for Population Oral Health,
The University of Adelaide.
Country [1] 289297 0
Australia
Primary sponsor type
Hospital
Name
Adelaide Dental Hospital
Address
Frome Road, Adelaide, south Australia, 5000.
Country
Australia
Secondary sponsor category [1] 287967 0
Hospital
Name [1] 287967 0
East Adelaide Oral and Maxillofacial Clinic
Address [1] 287967 0
1 Hutt Street
Adelaide 5000
South Australia
Country [1] 287967 0
Australia
Other collaborator category [1] 277974 0
Individual
Name [1] 277974 0
Dr Kamal Hanna
Address [1] 277974 0
Australian Research Centre for Population Oral Health, 122 Frome Street, Adelaide, South Australia, 5005
Country [1] 277974 0
Australia
Other collaborator category [2] 277975 0
Individual
Name [2] 277975 0
A/ Prof David Brennan
Address [2] 277975 0
Australian Research Centre for Population Oral Health, 122 Frome Street, Adelaide, South Australia, 5005
Country [2] 277975 0
Australia
Other collaborator category [3] 277976 0
Individual
Name [3] 277976 0
A/ Prof Jason Armfield
Address [3] 277976 0
Australian Research Centre for Population Oral Health, 122 Frome Street, Adelaide, South Australia, 5005
Country [3] 277976 0
Australia
Other collaborator category [4] 277977 0
Individual
Name [4] 277977 0
Dr Paul Sambrook
Address [4] 277977 0
Adelaide Dental Hospital, frome road, Adelaide, South Australia, 5000.
Country [4] 277977 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291061 0
The University of Adelaide
Ethics committee address [1] 291061 0
Ethics committee country [1] 291061 0
Australia
Date submitted for ethics approval [1] 291061 0
Approval date [1] 291061 0
30/05/2013
Ethics approval number [1] 291061 0
HS-2013-023
Ethics committee name [2] 293767 0
Royal Adelaide Hospital (HREC)
Ethics committee address [2] 293767 0
Ethics committee country [2] 293767 0
Australia
Date submitted for ethics approval [2] 293767 0
22/05/2015
Approval date [2] 293767 0
03/07/2015
Ethics approval number [2] 293767 0
HREC/14/RAH/160

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 618 618 0 0
/AnzctrAttachments/366415-Dr Hanna RAH HREC approval letter.pdf

Contacts
Principal investigator
Name 48718 0
A/Prof David Brennan
Address 48718 0
Australian Research Centre for Population Oral Health, 122 Frome Street, adelaide, South Australia, 5005.
Country 48718 0
Australia
Phone 48718 0
+61, 08, 83134046
Fax 48718 0
Email 48718 0
david.brennan@adelaide.edu.au
Contact person for public queries
Name 48719 0
Kamal Hanna
Address 48719 0
Australian Research Centre for Population Oral Health, 122 Frome Street, Adelaide, South Australia, 5005.
Country 48719 0
Australia
Phone 48719 0
+61, 08, 83135626
Fax 48719 0
Email 48719 0
kamal.hanna@adelaide.edu.au
Contact person for scientific queries
Name 48720 0
Kamal Hanna
Address 48720 0
Australian Research Centre for Population Oral HealthAustralian Research Centre for Population Oral Health, 122 Frome Street, Adelaide, South Australia, 5005.
Country 48720 0
Australia
Phone 48720 0
+61, 08, 83135626
Fax 48720 0
Email 48720 0
kamal.hanna@adelaide.edu.au

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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