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