Developing and Evaluating the Yorkshire Dialysis Decision Aid (YoDDA)
|ClinicalTrials.gov Identifier: NCT01671228|
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : May 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Failure||Other: Decision Aid Other: Decision aid + patient stories Other: Decision Aid + values task||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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 formatOther: 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 formatOther: 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
- 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
- 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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671228
|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|
|Principal Investigator:||Hilary L Bekker, PhD||University of Leeds|