To Develop a Validated Program and Use it to Evaluate Patients Post-operatively (Anesthesia)

October 5, 2017 updated by: Sudta Parakkamodom, Siriraj Hospital

The Develop a Validated Si-2-AQ and Use it to Evaluate Patients Postoperatively

Annually, the Department of Anesthesiology, Siriraj hospital has responsibilities to take care of more than 50,000 patients peri-operatively. According to Maslow's hierarchy of needs; human's pleasure is classified as physiological, safety, belonging, esteem and self-actualization. Since defining and measuring quality of healthcare service is an inevitable challenge for all institutes in medical fields, a questionnaire is developed to assess the quality of all services. The Siriraj Anesthesia Quality Assessment Questionnaire (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and convenience, Communication and Information, Process of care, Technical Quality, Psychological support, Physical support and Royalty.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Anesthesia service is the medical specialty that focuses on peri-operative medicine and the administration of anesthetics. It expresses traditionally as the conditions of no pain perception during surgical procedure. This includes three broad categories: 1) General Anesthesia is a medically induced state of unconsciousness with loss of protective reflexes; 2) Sedation is a state of irritability or agitation reduction to facilitate a medical or diagnostic procedure; and 3) Regional Anesthesia is a technique to abolish either or both motor and sensory sensitivity in a specific part of the body.

Siriraj Hospital, Mahidol University, Bangkok is a tertiary, general hospital with more than 2,200 beds. Annually, the Department of Anesthesiology has responsibilities to take care of more than 50,000 patients peri-operatively. Currently, it plays a part in many surgical departments: Traumatic surgery (TRAU); Orthopedics surgery (ORT); Eye surgery (EYE); Ear, Nose and Throat surgery (ENT); Plastics surgery (PLA); Cardio-thoracic surgery (CVT); Neurosurgery (NEU); General surgery (GEN), Urological surgery (URO); Head and Neck surgery (H&N); Pediatric surgery (PED); Obstetrics surgery (OBG); Gynecological surgery (GYN); Electro-convulsive therapy (PSY); Radiological services (RAD); Endoscopic center (SCOP); Intensive Care Unit (ICU); Acute Pain service (APS); Pain Clinic (PC); and Pre-Anesthesia Assessment Center (SiPAC).

According to Maslow's hierarchy of needs; human's pleasure is classified as physiological, safety, belonging, esteem and self-actualization. Likewise, patients' satisfaction seems to cover all these aspects; since participants crave for an excellent healthcare services. As a result, their contentment become a crucial factor to determine the quality of care particularly in Anesthesia procedure. This includes many processes in peri-Anesthesia management such as patient safety in operating theater, pain controlling and mutually convenient inter-relationship, etc. To solve these procedural running by means of patients' desires, a quality survey seems to be a promising tool that right on the target.

Since defining and measuring quality of healthcare service is an inevitable challenge for all institutes in medical fields, many organizations try to work out intensively. Currently, there are many leading quality assessment tools in healthcare services, namely Hospital Consumer Assessment of Healthcare Providers and System (HCAHPS), Patient Satisfaction Questionnaire (PSQ), Service Quality Questionnaire (SERVQUAL), Quality of Recover after anesthesia 40 (QoR-40), Post-operative Quality of Recovery Questionnaire and Developing and Testing Questionnaire. These tests have been already verified for its validity and reliability.

HCAHPS a 33-item survey in three dimensions, comprises nurse and doctor communication, medical communication, responsiveness of hospital staff, pain management, discharge information, care transition 17 items; cleanliness and quietness of hospital environment 2 items; as well as overall rating of hospital and willingness to recommend hospital 2 items.

PSQ an 18-item questionnaire in seven dimensions, consists of general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor as well as accessibility and convenience.

SERVQUAL a questionnaire related to hospital services in five dimensions, is composed of tangibles, reliability, responsiveness, assurance and empathy.

QoR-40 a 40-item questionnaire concerning good quality recovery after anesthesia and surgery, includes emotional states, physical and physiological support, physical independence and pain management.

Based upon the previously mentioned; investigators, therefore, would like to develop a questionnaire to assess the quality of our services. The Siriraj Anesthesia Quality Assessment Questionnaire (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and convenience (5 items), Communication and Information (10 items), Process of care (8 items), Technical Quality (9 items) Psychological support (4 items) Physical support (2 items) and Royalty (2 items).

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A developed and validated questionnaire will be studied in 450 patients as target group (4 months). Post-operatively, a nurse anesthetist visits a patient to explain the details of the study and ask for consent. Afterwards, a participant responses to a questionnaire privately (10 minutes). Co-investigators collect data in a computer file. A statistician who not involved in the study analyzes the data.

Description

Inclusion Criteria:

  • Volunteered, literate and communicable, well-conscious, in-patients ASA I-III, aged 18-65 years who underwent elective surgery.

Exclusion Criteria:

  • Patients with severe diseases such as congestive heart failure, end-stage renal disease, etc. Patients refuse to join the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' satisfaction
Time Frame: 4 months
questionnaires
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Chairal Shayakul, M.D., Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 23, 2017

Primary Completion (ANTICIPATED)

December 31, 2017

Study Completion (ANTICIPATED)

December 31, 2017

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (ESTIMATE)

January 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • COA no. Si 790/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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