Clinical trial NCT01671228: Developing and Evaluating the Yorkshire Dialysis Decision Aid
Official title: Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Failure
Keywords: dialysis
chronic kidney failure
informed choice
patient decision making
decision aid
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Kidney Cancer UK
name: National Health Service, United Kingdom
name: Baxter Healthcare Corporation
name: Foundation for Informed Medical Decision Making
First posted: 2012-08-23
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this research is to develop a patient decision aid in paper and web formats to help patients with chronic kidney disease make informed dialysis treatment decisions.

Detailed description: This research will develop and evaluate a paper and web resource known as a decision-aid to help patients make informed decisions about dialysis treatment. The Yorkshire Dialysis Decision Aid (YoDDA) will help patients' with chronic kidney disease make informed decisions between haemodialysis and peritoneal dialysis choices by a) re-writing dialysis information in a more meaningful way for patients, b) restructuring information to make this difficult decision more manageable, and c) using prompts to help patients imagine the choices' consequences. The research will assess the acceptability of a patient decision aid in paper and web versions to patients and their carers, and its impact on patients choices about dialysis.

The programme of research included:

A survey using qualitative methods of patients with chronic kidney disease and professionals providing predialysis services to develop the Yorkshire Dialysis Decision Aid content, and integration within usual predialysis care practices.

A before-and-after study was carried out to evaluate the acceptability of the YoDDA-booklet to patients with sustained deterioration of kidney function making dialysis decision across the Yorkshire and Humber region, UK.

An experimental study was carried out on-line to evaluate the acceptability of three versions of YoDDA-web (YoDDA; YoDDA+values tasks; YoDDA_patient videos) to people, or carers of people, with kidney disease. The study was advertised with flyers within UK renal units and notices on the National Kidney Federation's website and members' magazine.

Eligibility criteria: Inclusion Criteria: Adult patients with chronic kidney disease and carers of people with chronic kidney diseae who are making decisions about dialysis treatments.

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Exclusion Criteria: Those not literate in English

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Primary outcomes:
measure: Preparation for decision making scale
timeFrame: one and six weeks after provision information about dialysis choices
Secondary outcomes:
measure: Usefulness of information
timeFrame: one and six weeks after the provision of information
Other outcomes:
measure: Dialysis treatment preferences
timeFrame: one week and six weeks after the information
Locations:
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospital Trust
state: East Yorkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Northern General Teaching Hospital
state: South Yorkshire
city: Leeds
country: United Kingdom
facility: St James University Hospital
state: West Yorkshire
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospital
state: Yorkshire
city: York
country: United Kingdom
facility: York teaching Hospital NHS Foundation trust
state: Yorkshire
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
Study officials:
affiliation: University of Leeds
name: Hilary L Bekker, PhD
role: PRINCIPAL_INVESTIGATOR
References: