Developing and Evaluating the Yorkshire Dialysis Decision Aid (YoDDA)

April 30, 2014 updated by: Hilary L Bekker, University of Leeds

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

488

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Doncaster, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU3 2JZ
        • Hull and East Yorkshire Hospital Trust
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S57AU
        • Sheffield Northern General Teaching Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS97TF
        • St James University Hospital
    • Yorkshire
      • Bradford, Yorkshire, United Kingdom, BD5 0NA
        • Bradford Teaching Hospital
      • York, Yorkshire, United Kingdom, YO31 8HE
        • York Teaching Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preparation for decision making scale
Time Frame: one and six weeks after provision information about dialysis choices
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usefulness of information
Time Frame: one and six weeks after the provision 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialysis treatment preferences
Time Frame: one week and six weeks after the information
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

Baxter Healthcare Corporation
National Health Service, United Kingdom
Foundation for Informed Medical Decision Making
Kidney Cancer UK

Investigators

  • Principal Investigator: Hilary L Bekker, PhD, University of Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 23, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V4_01_JUN_12
  • SP2/Choices/2012 (Other Grant/Funding Number: Kidney Research UK)
  • 0171-1 (Other Grant/Funding Number: Foundation of Informed Decision Making research grant)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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