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
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Failure
Other: Decision Aid
Other: Decision aid + patient stories
Other: Decision Aid + values task
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments

Resource links provided by NLM:


Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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)


Enrollment: 488
Study Start Date: January 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: decision aid
The Yorkshire Dialysis Decision Aid (YoDDA). Delivered as a leaflet in clinic and a web resource outside the NHS.
Other: Decision Aid
The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
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.
Other: Decision Aid
The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
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 + patient stories
The Yorkshire Dialysis Decision Aid (YoDDA) + patient stories. Delivered as an web-based resource outside the NHS.
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
No Intervention: usual predialysis education
The consultations and information usually provided by the predialysis health professionals

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671228

Locations
United Kingdom
Hull and East Yorkshire Hospital Trust
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Sheffield Northern General Teaching Hospital
Sheffield, South Yorkshire, United Kingdom, S57AU
St James University Hospital
Leeds, West Yorkshire, United Kingdom, LS97TF
Bradford Teaching Hospital
Bradford, Yorkshire, United Kingdom, BD5 0NA
York teaching Hospital NHS Foundation trust
York, Yorkshire, United Kingdom, YO31 8HE
Doncaster Royal Infirmary
Doncaster, United Kingdom, DN2 5LT
Sponsors and Collaborators
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)
Investigators
Principal Investigator: Hilary L Bekker, PhD University of Leeds
  More Information

No publications provided

Responsible Party: Hilary L Bekker, Senior Lecturer in Behavioural Sciences and Chartered Psychologist, University of Leeds
ClinicalTrials.gov Identifier: NCT01671228     History of Changes
Other Study ID Numbers: V4_01_JUN_12, SP2/Choices/2012, 0171-1
Study First Received: August 16, 2012
Last Updated: April 30, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Leeds:
dialysis
chronic kidney failure
informed choice
patient decision making
decision aid

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014