The OPTIONS study. Evaluating a patients' decision tool (OPTIONS tool) for considering treatment choices for the elderly with end stage kidney disease.

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001090606

Enrollment

122

Registered

2014-10-14

Start date

2015-03-17

Completion date

2016-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

70 Years to No maximum

Healthy volunteers

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

Outcome results