Condition category
Urological and Genital Diseases
Date applied
02/03/2017
Date assigned
05/04/2017
Last edited
18/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hemodialysis (commonly known as kidney dialysis) is a way to remove waste from the blood when the kidneys are unable to do it on their own. This involves having the blood in the body be passed through a tube to a machine that is able to filter the waste. The blood is then passed back to the patient through another tube.This is usually done around four times a week and takes around four hours each session. As patients spend a long time in dialysis, it is important that patients are happy with their healthcare. Patients’ satisfaction can be an indicator of the quality of healthcare services. Measuring patient satisfaction involves developing and validating a complex instrument. The Scale for Evaluation of Hemodialysis Patient’s Satisfaction with Service (ESUR-HD scale) was developed by nurses and nephrologist (kidney doctors) in four different regions of Colombia that looked at satisfaction with service, personnel, medication and supplies, facilities and processes and phone contact. The aim of this study is to develop and validate ESUR-HD scale provided at a chronic kidney disease unit to see how well it can measure patient’s satisfaction with their care.

Who can participate?
Adults over the age of 19 undergoing hemodialysis

What does the study involve?
Participants who underwent hemodialysis are contacted by telephone and are asked questions about their care using the ESUR-HD scale. The ESUR-HD scale uses 44 items that are rated from one to five. Some participants are also evaluated using the SDIALOR scale (another scale for measuring patient satisfaction). These scores are compared. A group of participants are also re-surveyed two days after their first survey to see if the test is reliable. Some participants are re-surveyed one month after they have hemiodialysis in a newer clinic with newer equipment, waiting rooms, spaces and expert staff to see if the scale is sensitive to change.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.

Where is the study run from?
Renal Therapy Services (RTS) (Colombia)

When is the study starting and how long is it expected to run for?
January 2013 to December 2013

Who is funding the study?
Renal Therapy Services (RTS) (Colombia)

Who is the main contact?
Dr Mauricio Sanabria
mauricio_sanabria@baxter.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mauricio Sanabria

ORCID ID

http://orcid.org/0000-0002-5111-9832

Contact details

Renal Therapy Services (RTS) Colombia
Transversal 23 #97-73 Piso 6
Bogota
110221
Colombia
+57 315 3663465
mauricio_sanabria@baxter.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BHSR-D-16-00174

Study information

Scientific title

Validation of an Instrument for Measuring Satisfaction of Patients Undergoing Hemodialysis: ESUR-HD

Acronym

ESUR - HD

Study hypothesis

The aim of this study is to evaluate the psychometric properties of the Scale for Evaluation of Hemodialysis Patients' Satisfaction with Service (Spanish acronym ESUR) when applied to patients with chronic renal disease receiving hemodialysis treatment in renal care units in Colombia.

Ethics approval

Renal Therapy Services Colombia Ethics Committee,11/06/2013, ref: minutes 004

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Haemodialysis

Intervention

After conducting four focus groups that include three nurses, a nephrologist and two administrative employees in four different regions of Colombia that asked about patient satisfaction, a scale for evaluating patients' satisfaction with the renal services ESUR-HD was created. The focus group defined certain dimensions with patient satisfaction that include overall satisfaction with the services, personnel at the unit, medications and supplies, facilities and processes, and phone contact. The ESUR-HD scale uses 44 items that are rated from one to five using a Likert scale. The final score is obtained by non-weighted sum of the score given to each item (higher scores reflect increased patient satisfaction). The survey takes 15 minutes to complete.

Participants who underwent hemodialysis at the clinics in 2013 are contacted by telephone to participate in the ESUR-HD scale. In order to measure convergent validity, the SDIALOR scale is simultaneously applied in a smaller subgroup of patients. The SDIALOR scale consists of seven domains (organisation of medical care, relationship between nephrologists and general practitioner, locational characteristics, accessibility, care provided by the health personnel, information provided by the doctor, problem solving, overall satisfaction). In order to test the reliability of the study a smaller sample of participants were re-surveyed two days after their initial assessment to consider the scale length. In order to establish the sensitivity to change, another smaller sample of participants are re-evaluated one month after using a new renal clinical within a hospital that includes remodelled spaces, waiting rooms, newer equipment, with more familiar, expert and dedicated healthcare staff.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Convergent validity is assessed by comparing the correlation coefficients based on results of ESUR-HD and SDIALOR at baseline.
2. Test-retest reliability is measured using repeat surveys of ESUR-HD at baseline and day 2.
3. Sensitivity to change is assessed by comparing the ESUR- HD scale scores at baseline and one month after improved care conditions

Secondary outcome measures

No secondary outcome measures.

Overall trial start date

01/01/2013

Overall trial end date

01/12/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult patient undergoing hemodialysis
2. Colombian nationals
3. Speak Spanish
4. Aged 18 and older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

370

Participant exclusion criteria

1. Cognitive impairment, documented in the institutional clinical history, that prevents an adequate understanding of the questions contained in the instrument.
2. Sensory alterations, documented in the institutional clinical history, that prevent the patient from hearing the questions asked or responding to them in a telephone survey.

Recruitment start date

01/06/2013

Recruitment end date

01/09/2013

Locations

Countries of recruitment

Colombia

Trial participating centre

Renal Therapy Services (RTS) Colombia
Transv 23 # 97-73 Sixth Floor
Bogotá
110221

Sponsor information

Organisation

Renal Therapy Services (RTS) Colombia

Sponsor details

Transversal 23#97-73 Floor 6
Bogota
110221
Colombia
+57 315 366 3465
mauricio_sanabria@baxter.com

Sponsor type

Other

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Renal Therapy Services (RTS) Colombia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Mauricio Sanabria: mauricio_sanabria@baxter.com.

Intention to publish date

31/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/07/2017: Intention to publish date added.