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NCT01671228 Clinical Trial

Developing and Evaluating the Yorkshire Dialysis Decision Aid

Chronic Kidney Failure Clinical Trial

— YoDDA  

Official title:
Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01671228
Other study ID # V4_01_JUN_12
Secondary ID SP2/Choices/2012
Status Completed
Phase Phase 1
First received August 16, 2012
Last updated April 30, 2014
Start date January 2011
Est. completion date March 2014

Study information
Verified date April 2014
Source University of Leeds
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 488
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: Adult patients with chronic kidney disease and carers of people with chronic kidney diseae who are making decisions about dialysis treatments.

Exclusion Criteria: Those not literate in English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Other:
• Decision Aid
The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
• Decision aid + patient stories
The Yorkshire dialysis decision aid (YoDDA) plus a set of narratives provided by patients on the treatment options (home and hospital haemodialysis; continuous ambulatory and automated peritoneal dialysis
• Decision Aid + values task
The Yorkshire Dialysis decision aid (YoDDA) plus a set of questions to help patients explore what aspects of their life important to them about this decision (values clarification)

Locations
Country Name City State
United Kingdom Bradford Teaching Hospital Bradford Yorkshire
United Kingdom Doncaster Royal Infirmary Doncaster
United Kingdom Hull and East Yorkshire Hospital Trust Hull East Yorkshire
United Kingdom St James University Hospital Leeds West Yorkshire
United Kingdom Sheffield Northern General Teaching Hospital Sheffield South Yorkshire
United Kingdom York teaching Hospital NHS Foundation trust York Yorkshire

Sponsors (5)
Lead Sponsor Collaborator
University of Leeds Baxter Healthcare Corporation, Foundation for Informed Medical Decision Making, Kidney Research UK, National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Dialysis treatment preferences Study specific measure asking patients to rank order their preferred dialysis treatment (CAPD, APD, home HD, centre HD) one week and six weeks after the information No
Primary Preparation for decision making scale Assesses patient's perception of how useful the resource was in helping patients prepare for a consultation to talk about their health decision (Graham and O'Connor, 2010). http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_PrepDM.pdf one and six weeks after provision information about dialysis choices No
Secondary Usefulness of information Study specific items to assess perceived usefulness of information in helping patients understand chronic kidney disease, dialysis treatments and thinking about dialysis one and six weeks after the provision of information No
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