Validation of an instrument for measuring satisfaction of patients undergoing hemodialysis
| ISRCTN | ISRCTN45318400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45318400 |
| Secondary identifying numbers | BHSR-D-16-00174 |
- Submission date
- 02/03/2017
- Registration date
- 05/04/2017
- Last edited
- 26/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Renal Therapy Services (RTS) Colombia
Transversal 23 #97-73 Piso 6
Bogota
110221
Colombia
 ORCID ID |
0000-0002-5111-9832 |
|---|---|
| Phone | +57 315 3663465 |
| mauricio_sanabria@baxter.com |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Validation of an Instrument for Measuring Satisfaction of Patients Undergoing Hemodialysis: ESUR-HD |
| Study acronym | ESUR - HD |
| Study objectives | 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(s) | Renal Therapy Services Colombia Ethics Committee,11/06/2013, ref: minutes 004 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2013 |
| Completion date | 01/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 370 |
| Total final enrolment | 370 |
| Key inclusion criteria | 1. Adult patient undergoing hemodialysis 2. Colombian nationals 3. Speak Spanish 4. Aged 18 and older |
| Key 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. |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 01/09/2013 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Sixth Floor
Bogotá
110221
Colombia
Sponsor information
Other
Transversal 23#97-73 Floor 6
Bogota
110221
Colombia
| Phone | +57 315 366 3465 |
|---|---|
| mauricio_sanabria@baxter.com | |
"ROR" |
https://ror.org/02a9kts05 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/05/2017 | 26/11/2020 | Yes | No |
Editorial Notes
26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
18/07/2017: Intention to publish date added.
