The OPTIONS study. Evaluating a patients' decision tool (OPTIONS tool) for considering treatment choices for the elderly with end stage kidney disease.
Not Applicable
Recruiting
- Conditions
- Chronic Kidney DiseaseRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12614001090606
- Lead Sponsor
- Queensland University of Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 122
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
Exclusion Criteria
Non english speaking
Declared medically incompetent
Eligible for kidney transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[This outcome will be measured at time point 1 - one month after delivery of intervention - OPTIONS tool.];Decision as measured by Decision Regret Scale[Repeated measurement - Time point 1 - one month, Time point 2 - three months, Time point 3 - 6 months]
- Secondary Outcome Measures
Name Time Method 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.[Time point 1 - one month];Quality of life as measured by SF-36 Vs2.1.[Time point 1 - one month<br>Time point 2 - three months<br>Time point 3 - six months];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.[Time point 1 - one month]