Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001090606
Ethics application status
Approved
Date submitted
23/09/2014
Date registered
14/10/2014
Date last updated
3/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The OPTIONS study. Evaluating a patients' decision tool (OPTIONS tool) for considering treatment choices for the elderly with end stage kidney disease.
Scientific title
A pragmatic randomised controlled trial of the OPTIONS tool to measure effectiveness of this intervention in reducing decisional conflict and uncertainty for patients' 70 years and older with a kidney function of 20mL/min or less, when choosing between dialysis or non-dialysis treatments.
Secondary ID [1] 285239 0
None
Universal Trial Number (UTN)
U1111-1160-9388
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 292871 0
Condition category
Condition code
Renal and Urogenital 293168 293168 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a decision aid called "OPTIONS Tool" which consists of a self-administered audio workbook, audio recording and personal worksheet. The information within the booklet and audio recording is based on evidence generated from a Systematic Review the researcher has undertaken and covers specific issues such as prognosis, risk and benefits of dialysis, burden of dialysis and non-dialysis management. Once the participant has been randomised to receive the intervention they will be given a DVD, booklet and personal worksheet which they will take home to review and complete with their family. They will return in one months time (as will those who have been randomised to standard education) where a training clinician will provide counselling to ensure the decision they have made best matches their personal values. The booklet, audio recording and personal worksheet will take approximately 30 minutes to complete. There are no strategies undertaken to monitor adherence apart from review of personal worksheet at the clinic appointment with the trained clinician one month after receiving the intervention. It is anticipated that the clinic appointment at one month will take approximately 30 - 45 minutes for both intervention and standard care.
Intervention code [1] 290116 0
Treatment: Other
Comparator / control treatment
Standard education currently delivered to patients 70 years and over with a kidney function of 20mL/min or less. This standard education may differ between sites. The information presented to the participant may differ depending on the clinical condition of the patient and the philosophy of the clinician. At all sites there is a formalised education program including group education sessions and one-on-one sessions. There are a variety of booklets that may be given to the patients, these are available at all sites. Standard education is generalised with no targeted education to a specific age group.
Control group
Active

Outcomes
Primary outcome [1] 293024 0
The primary outcome of the study is decision conflict and uncertainty in decision making. This is observed through recorded scores in the decision conflict scale. The decision conflict scale has been developed by Ottawa Hospital Health Research institute to measure both decisional conflict and uncertainty. The scale has been validated in low literacy populations.
Timepoint [1] 293024 0
This outcome will be measured at time point 1 - one month after delivery of intervention - OPTIONS tool.
Primary outcome [2] 295407 0
Decision as measured by Decision Regret Scale
Timepoint [2] 295407 0
Repeated measurement - Time point 1 - one month, Time point 2 - three months, Time point 3 - 6 months
Secondary outcome [1] 310200 0
Knowledge of options and benefits and harms of these options. Measured by Knowledge questionnaire. This questionnaire was adapted from a template developed by AM O’Conor, Sample Tool: Knowledge (Taoxifen) Copyright 1999. Available from https://decisionaid.ohri.ca/eval_know.html. Content of this decision aid is based on best available evidence. Framework of Knowledge questionnaire has been validated.
Timepoint [1] 310200 0
Time point 1 - one month
Secondary outcome [2] 310203 0
Quality of life as measured by SF-36 Vs2.1.
Timepoint [2] 310203 0
Time point 1 - one month
Time point 2 - three months
Time point 3 - six months
Secondary outcome [3] 310204 0
Preparation for decision making has been designed to assess both the patient's and clinician's perception of how useful the OPTIONS tool was in preparing them for decision making. Preparation for decision making scale will be used to measure this.
Timepoint [3] 310204 0
Time point 1 - one month

Eligibility
Key inclusion criteria
Age equal to/greater than 70 years of age
Glomerular Filtration rate - equal to/less than 20 mL/min
No prior decision made regarding treatment options
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non english speaking
Declared medically incompetent
Eligible for kidney transplant

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)
Allocation involving contacting the holder of the allocation schedule who is "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation has been undertaken based on secondary outcome 'decision regret scale'. The effect size used within this calculation was 15%. Calculations based on 90% power and a type 1 error rate (two-tailed) of 5%. Minimum sample size is 122 patients with 61 patients for each study arm.
Data analysis conducted on intention-to-treat basis. Measurements with only one measure - mean and Standard deviations utilising unpaired t-test if normal distribution. If non-parametric then Mann-Whitney test performed.
For repeated measures - paired t test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/11/2014
Actual
17/03/2015
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
122
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2918 0
Hervey Bay Hospital - Pialba
Recruitment hospital [2] 2919 0
Maryborough Hospital - Maryborough
Recruitment hospital [3] 2920 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 3014 0
Nambour General Hospital - Nambour
Recruitment hospital [5] 5907 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 8643 0
4655 - Hervey Bay
Recruitment postcode(s) [2] 8644 0
4650 - Maryborough
Recruitment postcode(s) [3] 8645 0
4000 - Brisbane
Recruitment postcode(s) [4] 8727 0
4560 - Nambour
Recruitment postcode(s) [5] 13352 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 289858 0
Other Collaborative groups
Name [1] 289858 0
The Australian Centre for Health Services Innovation (AusHSI)
Country [1] 289858 0
Australia
Funding source category [2] 293743 0
Government body
Name [2] 293743 0
Queensland Health
Country [2] 293743 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Nursing
Queensland University of Technology
Level 4, 88 Musk Ave, Kelvin Grove
Qld 4059 Australia
Country
Australia
Secondary sponsor category [1] 288540 0
None
Name [1] 288540 0
Address [1] 288540 0
Country [1] 288540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291704 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 291704 0
HREC Office
Royal Brisbane & Women's Hospital
Level 7
Block 7
Butterfield St
Herston. Qld 4029
Ethics committee country [1] 291704 0
Australia
Date submitted for ethics approval [1] 291704 0
29/09/2014
Approval date [1] 291704 0
24/11/2014
Ethics approval number [1] 291704 0
HREC/14/QRBW/425
Ethics committee name [2] 293083 0
UHREC - Queensland University of Technology
Ethics committee address [2] 293083 0
Office of Research Ethics & Integrity
Level 4, 88 Musk Avenue, Kelvin Grove 4059.QLD
Ethics committee country [2] 293083 0
Australia
Date submitted for ethics approval [2] 293083 0
Approval date [2] 293083 0
20/01/2015
Ethics approval number [2] 293083 0
UHREC 1400000937

Summary
Brief summary
The aim of the study is to examine the effectiveness of an evidence based decision making intervention (OPTIONS tool) for older people considering treatment options for end stage kidney disease. The anticipated study outcome will be reduced decisional conflict and uncertainty, improved knowledge regarding benefits and harms of dialysis and lower decisional regret.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50998 0
Ms Leanne Brown
Address 50998 0
Renal Unit
Hervey Bay Hospital
PO Box592
Pialba. 4655. Qld
Country 50998 0
Australia
Phone 50998 0
+61 448143303
Fax 50998 0
+61 743256787
Email 50998 0
[email protected]
Contact person for public queries
Name 50999 0
Ms Leanne Brown
Address 50999 0
Renal Unit
Hervey Bay Hospital
PO Box592
Pialba. 4655. Qld
Country 50999 0
Australia
Phone 50999 0
+61 448143303
Fax 50999 0
+61 7 43256787
Email 50999 0
[email protected]
Contact person for scientific queries
Name 51000 0
Ms Leanne Brown
Address 51000 0
Renal Unit
Hervey Bay Hospital
PO Box592
Pialba. 4655. Qld
Country 51000 0
Australia
Phone 51000 0
+61 448143303
Fax 51000 0
+61 743256787
Email 51000 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
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial testing a decision support intervention for older patients with advanced kidney disease.2019https://dx.doi.org/10.1111/jan.14112
N.B. These documents automatically identified may not have been verified by the study sponsor.