Developing and Evaluating the Yorkshire Dialysis Decision Aid (YoDDA)

This study has been completed.
Sponsor:
Collaborators:
Kidney Research UK
National Health Service, United Kingdom
Baxter Healthcare Corporation
Foundation for Informed Medical Decision Making
X-Lab systems, University of Leeds (www.x-labsystems.co.uk)
Information provided by (Responsible Party):
Hilary L Bekker, University of Leeds
ClinicalTrials.gov Identifier:
NCT01671228
First received: August 16, 2012
Last updated: April 30, 2014
Last verified: April 2014

August 16, 2012
April 30, 2014
January 2011
March 2014   (final data collection date for primary outcome measure)
Preparation for decision making scale [ Time Frame: one and six weeks after provision information about dialysis choices ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01671228 on ClinicalTrials.gov Archive Site
Usefulness of information [ Time Frame: one and six weeks after the provision of information ] [ Designated as safety issue: No ]
Study specific items to assess perceived usefulness of information in helping patients understand chronic kidney disease, dialysis treatments and thinking about dialysis
Same as current
Dialysis treatment preferences [ Time Frame: one week and six weeks after the information ] [ Designated as safety issue: No ]
Study specific measure asking patients to rank order their preferred dialysis treatment (CAPD, APD, home HD, centre HD)
Same as current
 
Developing and Evaluating the Yorkshire Dialysis Decision Aid
Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Chronic Kidney Failure
  • Other: Decision Aid
    The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
  • Other: 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
  • Other: 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)
  • Experimental: decision aid
    The Yorkshire Dialysis Decision Aid (YoDDA). Delivered as a leaflet in clinic and a web resource outside the NHS.
    Intervention: Other: Decision Aid
  • Experimental: Decision Aid + values task
    The Yorkshire Dialysis Decision Aid (YoDDA) + values clarification questions. delivered as a leaflet in clinic and a web-based resource outside the NHS.
    Interventions:
    • Other: Decision Aid
    • Other: Decision Aid + values task
  • Experimental: Decision Aid + patient stories
    The Yorkshire Dialysis Decision Aid (YoDDA) + patient stories. Delivered as an web-based resource outside the NHS.
    Interventions:
    • Other: Decision Aid
    • Other: Decision aid + patient stories
  • No Intervention: usual predialysis education
    The consultations and information usually provided by the predialysis health professionals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
March 2014
March 2014   (final data collection date for primary outcome measure)

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

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01671228
V4_01_JUN_12, SP2/Choices/2012, 0171-1
Yes
Hilary L Bekker, University of Leeds
University of Leeds
  • Kidney Research UK
  • National Health Service, United Kingdom
  • Baxter Healthcare Corporation
  • Foundation for Informed Medical Decision Making
  • X-Lab systems, University of Leeds (www.x-labsystems.co.uk)
Principal Investigator: Hilary L Bekker, PhD University of Leeds
University of Leeds
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP