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Not yet recruitingNCT05931809Updated Jul 5, 2023

Evaluation of the Perception of Quality of Care of Patients Admitted to a Medical-Surgical ICU

An observational study in Critically Ill, sponsored by Hospital Sao Domingos. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by Hospital Sao Domingos · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this prospective observational cohort study is to describe the perception of quality of care of patients or reference companions admitted to a medical-surgical ICU.

Read the detailed description

Background: Quality assessment in health systems is essential for the improvement and development of services. Assessments using the structure, process and outcomes model are the most widespread, however understanding the health system as a business model makes assessment essential. how much the service is able to meet the expectations of the patient and the market.

The Institute for Healthcare Improvement (IHI) highlights three domains (Triple aim) in which health systems must develop. Among them is "Improving the patient experience". One of the 6 domains of quality of care is patient-centeredness. Several funding institutions and scientific authorities have, in recent years, encouraged patient-centered clinical research with the use of outcomes that are also patient-centered.

The perception of the quality of the service provided to the critically ill patient or even is an uncommon outcome in the literature, especially evaluated with an objective and effective tool.

The SERVQUAL tool proposed by Parasuraman et al. It aims to compare the expectations and perceptions of the patient/companion regarding the quality of care provided.

In the literature, data on patient-centered perspectives and demands are scarce.

Purpose: To identify the difference between expectation and perception of care quality during the stay in the general ICU of a tertiary hospital. Objectives: To evaluate the perception of quality of care of patients admitted to a general ICU through the SERVQUAL tool translated and culturally adapted to the portuguese idiom.

Methods: A prospective, observational cohort study involving adult patients admitted to the general ICU (53 beds) of a tertiary hospital from July 1 to September 30, 2023. The SERVQUAL tool questionnaire of expectations will be applied in the first 24 hours after admission to the ICU and the perception questionnaire applied in the first 24 hours after discharge from the unit.

02

Conditions studied

  • Critically Ill

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Keywords

  • Critically ill patients
  • Servqual tool
  • Quality of care
  • Expectations
  • Perceptions
03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's planned enrollment of 200 is above the median of 140 across 814 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Hospital Sao Domingos is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All adult patients admitted to the 53 beds general ICU during the study period. The SERVQUAL scale will be applied with the questionnaire of expectations in the first 24 hours of admission and perception questionnaire within the first 24 hours after discharge.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients ≥ 18 years old
  • consent form signed by the patient or a family member.

Exclusion criteria

Exclusion Criteria:

  • Patients unable to respond and who do not have reference companions
  • Patients readmitted to the ICU during the study period.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • BehavioralSerqual tool

    The SERVQUAL scale will be applied with the questionnaire of expectations in the first 24 hours after admission and perception questionnaire within the first 24 hours after discharge.

06

What researchers measure

Primary outcomes

  1. Servqual tool

    The questionnaire consists of 5 domains with 22 questions graded from 1 to 7 according to perceived quality and expected in each sphere of care delivery. Domains are: 1. Tangibles. Equipment, physical structure, presentation of professionals and materials. 2. Reliability. Ability to resolve problems and resolve them within the deadline, and record without errors. 3. Availability and responsiveness. Ability to inform about the therapeutic plan, to execute on time, availability of professionals to help clients and degree of occupation of professionals to meet demands. 4. Security / Trust. Ability to inspire security, education of professionals and knowledge of processes by professionals. 5. Empathy. To provide individual attention, standard opening hours, sincere interest in resolving demands and ability to meet demands individually. The result is analyzed with the calculation: Average result of reality - Average result of expectation = Gap of perception of quality of care.

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Burstin H, Leatherman S, Goldmann D. The evolution of healthcare quality measurement in the United States. J Intern Med. 2016 Feb;279(2):154-9. doi: 10.1111/joim.12471. PubMed 26785953 ↗
  • Sixma HJ, Kerssens JJ, Campen CV, Peters L. Quality of care from the patients' perspective: from theoretical concept to a new measuring instrument. Health Expect. 1998 Nov;1(2):82-95. doi: 10.1046/j.1369-6513.1998.00004.x. PubMed 11281863 ↗
  • Jonkisz A, Karniej P, Krasowska D. The Servqual Method as an Assessment Tool of the Quality of Medical Services in Selected Asian Countries. Int J Environ Res Public Health. 2022 Jun 26;19(13):7831. doi: 10.3390/ijerph19137831. PubMed 35805492 ↗
  • Malathi A, Jasim KM. Validating the relationship between service quality, patient sensitivity and experience towards medical applications using SERVQUAL. Int J Med Inform. 2022 Dec;168:104883. doi: 10.1016/j.ijmedinf.2022.104883. Epub 2022 Oct 5. PubMed 36209699 ↗
  • Regaira Martinez E, Sola Iriarte M, Goni Viguria R, Del Barrio Linares M, Margall Coscojuela MA, Asiain Erro MC. [Care quality in intensive care evaluated by the patients using a service quality scale (SERVQUAL)]. Enferm Intensiva. 2010 Jan-Mar;21(1):3-10. doi: 10.1016/j.enfi.2009.10.001. Epub 2010 Feb 1. Spanish. PubMed 20170830 ↗
  • Lu SJ, Kao HO, Chang BL, Gong SI, Liu SM, Ku SC, Jerng JS. Identification of quality gaps in healthcare services using the SERVQUAL instrument and importance-performance analysis in medical intensive care: a prospective study at a medical center in Taiwan. BMC Health Serv Res. 2020 Sep 29;20(1):908. doi: 10.1186/s12913-020-05764-8. PubMed 32993641 ↗
  • Fan LH, Gao L, Liu X, Zhao SH, Mu HT, Li Z, Shi L, Wang LL, Jia XL, Ha M, Lou FG. Patients' perceptions of service quality in China: An investigation using the SERVQUAL model. PLoS One. 2017 Dec 22;12(12):e0190123. doi: 10.1371/journal.pone.0190123. eCollection 2017. PubMed 29272312 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2023; primary completion for Sep 2023, 2 months later.

Of 439 non-industry observational studies under Critical Illness, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 2 months is below that.

Counting every sponsor, half of 442 studies reached it within 23 months; a quarter within 12 and three quarters within 46.

Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2023
First posted
Jul 5, 2023
StartEst.
Jul 1, 2023
Primary completionEst.
Sep 30, 2023
CompletionEst.
Nov 2023
Last update
Jul 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05931809
Lead sponsor
Hospital Sao Domingos
Responsible party
José Raimundo Araujo de Azevedo (ICU Assistent Physician, Hospital Sao Domingos) — Principal investigator
First posted
Jul 5, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Sep 30, 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Jul 5, 2023

Study contacts

JOSE AZEVEDO, MD, PhD
Contact
jrazevedo47@gmail.com
+559832168110
LUIS TUPINAMBA JR, MD
Contact
francatupinamba@hotmail.com
+559832168110

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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