Perceptions of Illness Severity, Treatment Goals and Life Expectancy (ePISTLE)

October 19, 2022 updated by: Imperial College London

The ePISTLE Study: Perceptions of Illness Severity, Treatment Goals and Life Expectancy

This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sharing and communicating information with patients is an integral part of medical care, yet research has shown that disparities exist between physicians and patient perceptions of illness severity. In renal medicine, along with many other specialties, expected prognosis can affect treatment offered.Thus appreciating and understanding one's prognosis can influence patients and relatives' expectations for treatment and guide discussions regarding quality of life.

Previous work has highlighted disparities in the United States between expectations of survival of seriously ill haemodialysis patients and their physicians. The investigators plan to repeat this study within the United Kingdom, to see whether similar issues occur and to elucidate current practice on discussions of prognosis, symptom burden and transplant candidacy. The investigators hope to identify where care can be improved and to enable patients to better make informed decisions on treatment and goals of care.

Part one of the study is to repeat this study in haemodialysis patients in the United Kingdom. This has been completed and published (2021) at https://www.kireports.org/article/S2468-0249(21)00103-0/fulltext.

Part two of the study is to extend the study to peritoneal dialysis patients in the United Kingdom.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

Study Contact

Study Locations

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Dialysis patients

Description

Inclusion Criteria:

  • Haemodialysis patients 18-100 years old, with a predicted mortality risk of >20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.
  • Peritoneal dialysis patients 18-100 years old, with a predicted mortality risk of >20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.

Exclusion Criteria:

  • Patients on home haemodialysis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemodialysis patients
Patients undergoing hemodialysis
Other: Questionnaire/Structured Interview
No intervention
Peritoneal dialysis patients
Patients undergoing peritoneal dialysis
Other: Questionnaire/Structured Interview
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current practice regarding discussion of prognosis with seriously ill dialysis patients, to better understand the dissonance between physician and patient beliefs on prognosis, transplant candidacy and goals of care.
Time Frame: Through study completion, an average of 2 years
Completion of questionnaire or structured interview
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of dialysis patients who are more optimistic about prognosis and transplant candidacy than their nephrologists
Time Frame: Through study completion, an average of 2 years
Completion of questionnaire or structured interview
Through study completion, an average of 2 years
Patients' prognostic expectations are associated with their treatment preferences
Time Frame: Through study completion, an average of 2 years
Completion of questionnaire or structured interview
Through study completion, an average of 2 years
Number of patients with dialysis associated symptoms as assessed by IPOS Renal (https://pos-pal.org/maix/ipos-renal-in-english.php).
Time Frame: 7 days
Completion of questionnaire or structured interview
7 days

Collaborators and Investigators

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

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Edwina Brown, MBChB, Imperial College London

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 (Actual)

November 16, 2018

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18HH4336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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