NCT05931809

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 17, 2023

Last Update Submit

July 1, 2023

Conditions

Keywords

Critically ill patientsServqual toolQuality of careExpectationsPerceptions

Outcome Measures

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.

    30 days

Interventions

Serqual toolBEHAVIORAL

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

JOSE AZEVEDO, MD, PhD

CONTACT

LUIS TUPINAMBA JR, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ICU Assistent Physician

Study Record Dates

First Submitted

June 17, 2023

First Posted

July 5, 2023

Study Start

July 1, 2023

Primary Completion

September 30, 2023

Study Completion

November 1, 2023

Last Updated

July 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share