Developing and Evaluating the Yorkshire Dialysis Decision Aid

Phase 1

Completed

• Conditions: Chronic Kidney Failure
• Interventions: Other: Decision Aid; Other: Decision Aid + values task; Other: Decision aid + patient stories

• Registration Number: NCT01671228
• Lead Sponsor: University of Leeds

Brief 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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-23
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
decision aid	Decision Aid	The Yorkshire Dialysis Decision Aid (YoDDA). Delivered as a leaflet in clinic and a web resource outside the NHS.
Decision Aid + values task	Decision Aid	The Yorkshire Dialysis Decision Aid (YoDDA) + values clarification questions. delivered as a leaflet in clinic and a web-based resource outside the NHS.
Decision Aid + values task	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.
Decision Aid + patient stories	Decision Aid	The Yorkshire Dialysis Decision Aid (YoDDA) + patient stories. Delivered as an web-based resource outside the NHS.
Decision Aid + patient stories	Decision aid + patient stories	The Yorkshire Dialysis Decision Aid (YoDDA) + patient stories. Delivered as an web-based resource outside the NHS.

Primary Outcome Measures

Name	Time	Method
Preparation for decision making scale	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

Secondary Outcome Measures

Name	Time	Method
Usefulness of information	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

Trial Locations

Locations (6)

Bradford Teaching Hospital; 🇬🇧 Bradford, Yorkshire, United Kingdom

Hull and East Yorkshire Hospital Trust; 🇬🇧 Hull, East Yorkshire, United Kingdom

Sheffield Northern General Teaching Hospital; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

York teaching Hospital NHS Foundation trust; 🇬🇧 York, Yorkshire, United Kingdom

Doncaster Royal Infirmary; 🇬🇧 Doncaster, United Kingdom

St James University Hospital; 🇬🇧 Leeds, West Yorkshire, United Kingdom