<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03037996</url>
  </required_header>
  <id_info>
    <org_study_id>COA no. Si 790/2016</org_study_id>
    <nct_id>NCT03037996</nct_id>
  </id_info>
  <brief_title>To Develop a Validated Program and Use it to Evaluate Patients Post-operatively</brief_title>
  <acronym>Anesthesia</acronym>
  <official_title>The Develop a Validated Si-2-AQ and Use it to Evaluate Patients Postoperatively</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Siriraj Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Siriraj Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Annually, the Department of Anesthesiology, Siriraj hospital has responsibilities to take&#xD;
      care of more than 50,000 patients peri-operatively. According to Maslow's hierarchy of needs;&#xD;
      human's pleasure is classified as physiological, safety, belonging, esteem and&#xD;
      self-actualization. Since defining and measuring quality of healthcare service is an&#xD;
      inevitable challenge for all institutes in medical fields, a questionnaire is developed to&#xD;
      assess the quality of all services. The Siriraj Anesthesia Quality Assessment Questionnaire&#xD;
      (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and&#xD;
      convenience, Communication and Information, Process of care, Technical Quality, Psychological&#xD;
      support, Physical support and Royalty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anesthesia service is the medical specialty that focuses on peri-operative medicine and the&#xD;
      administration of anesthetics. It expresses traditionally as the conditions of no pain&#xD;
      perception during surgical procedure. This includes three broad categories: 1) General&#xD;
      Anesthesia is a medically induced state of unconsciousness with loss of protective reflexes;&#xD;
      2) Sedation is a state of irritability or agitation reduction to facilitate a medical or&#xD;
      diagnostic procedure; and 3) Regional Anesthesia is a technique to abolish either or both&#xD;
      motor and sensory sensitivity in a specific part of the body.&#xD;
&#xD;
      Siriraj Hospital, Mahidol University, Bangkok is a tertiary, general hospital with more than&#xD;
      2,200 beds. Annually, the Department of Anesthesiology has responsibilities to take care of&#xD;
      more than 50,000 patients peri-operatively. Currently, it plays a part in many surgical&#xD;
      departments: Traumatic surgery (TRAU); Orthopedics surgery (ORT); Eye surgery (EYE); Ear,&#xD;
      Nose and Throat surgery (ENT); Plastics surgery (PLA); Cardio-thoracic surgery (CVT);&#xD;
      Neurosurgery (NEU); General surgery (GEN), Urological surgery (URO); Head and Neck surgery&#xD;
      (H&amp;N); Pediatric surgery (PED); Obstetrics surgery (OBG); Gynecological surgery (GYN);&#xD;
      Electro-convulsive therapy (PSY); Radiological services (RAD); Endoscopic center (SCOP);&#xD;
      Intensive Care Unit (ICU); Acute Pain service (APS); Pain Clinic (PC); and Pre-Anesthesia&#xD;
      Assessment Center (SiPAC).&#xD;
&#xD;
      According to Maslow's hierarchy of needs; human's pleasure is classified as physiological,&#xD;
      safety, belonging, esteem and self-actualization. Likewise, patients' satisfaction seems to&#xD;
      cover all these aspects; since participants crave for an excellent healthcare services. As a&#xD;
      result, their contentment become a crucial factor to determine the quality of care&#xD;
      particularly in Anesthesia procedure. This includes many processes in peri-Anesthesia&#xD;
      management such as patient safety in operating theater, pain controlling and mutually&#xD;
      convenient inter-relationship, etc. To solve these procedural running by means of patients'&#xD;
      desires, a quality survey seems to be a promising tool that right on the target.&#xD;
&#xD;
      Since defining and measuring quality of healthcare service is an inevitable challenge for all&#xD;
      institutes in medical fields, many organizations try to work out intensively. Currently,&#xD;
      there are many leading quality assessment tools in healthcare services, namely Hospital&#xD;
      Consumer Assessment of Healthcare Providers and System (HCAHPS), Patient Satisfaction&#xD;
      Questionnaire (PSQ), Service Quality Questionnaire (SERVQUAL), Quality of Recover after&#xD;
      anesthesia 40 (QoR-40), Post-operative Quality of Recovery Questionnaire and Developing and&#xD;
      Testing Questionnaire. These tests have been already verified for its validity and&#xD;
      reliability.&#xD;
&#xD;
      HCAHPS a 33-item survey in three dimensions, comprises nurse and doctor communication,&#xD;
      medical communication, responsiveness of hospital staff, pain management, discharge&#xD;
      information, care transition 17 items; cleanliness and quietness of hospital environment 2&#xD;
      items; as well as overall rating of hospital and willingness to recommend hospital 2 items.&#xD;
&#xD;
      PSQ an 18-item questionnaire in seven dimensions, consists of general satisfaction, technical&#xD;
      quality, interpersonal manner, communication, financial aspects, time spent with doctor as&#xD;
      well as accessibility and convenience.&#xD;
&#xD;
      SERVQUAL a questionnaire related to hospital services in five dimensions, is composed of&#xD;
      tangibles, reliability, responsiveness, assurance and empathy.&#xD;
&#xD;
      QoR-40 a 40-item questionnaire concerning good quality recovery after anesthesia and surgery,&#xD;
      includes emotional states, physical and physiological support, physical independence and pain&#xD;
      management.&#xD;
&#xD;
      Based upon the previously mentioned; investigators, therefore, would like to develop a&#xD;
      questionnaire to assess the quality of our services. The Siriraj Anesthesia Quality&#xD;
      Assessment Questionnaire (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises&#xD;
      Accessibility and convenience (5 items), Communication and Information (10 items), Process of&#xD;
      care (8 items), Technical Quality (9 items) Psychological support (4 items) Physical support&#xD;
      (2 items) and Royalty (2 items).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Months</target_duration>
  <primary_outcome>
    <measure>Patients' satisfaction</measure>
    <time_frame>4 months</time_frame>
    <description>questionnaires</description>
  </primary_outcome>
  <enrollment type="Actual">450</enrollment>
  <condition>Patient Relations, Nurse</condition>
  <condition>Post-operative Patients</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patients' response</intervention_name>
    <description>patients' satisfaction to anesthesia services</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A developed and validated questionnaire will be studied in 450 patients as target group (4&#xD;
        months). Post-operatively, a nurse anesthetist visits a patient to explain the details of&#xD;
        the study and ask for consent. Afterwards, a participant responses to a questionnaire&#xD;
        privately (10 minutes). Co-investigators collect data in a computer file. A statistician&#xD;
        who not involved in the study analyzes the data.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteered, literate and communicable, well-conscious, in-patients ASA I-III, aged&#xD;
             18-65 years who underwent elective surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe diseases such as congestive heart failure, end-stage renal&#xD;
             disease, etc. Patients refuse to join the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chairal Shayakul, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok Noi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkoknoi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Siriraj Hospital</investigator_affiliation>
    <investigator_full_name>Sudta Parakkamodom</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>anesthesia</keyword>
  <keyword>satisfaction</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037996
org study id: COA no. Si 790/2016
nct id: NCT03037996
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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).
observational model: Cohort
time perspective: Prospective
measure: Patients' satisfaction
time frame: 4 months
description: questionnaires
intervention type: Other
intervention name: patients' response
description: patients' satisfaction to anesthesia services
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chairal Shayakul, M.D.
role: Study Chair
affiliation: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
facility: 
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Siriraj Hospital
investigator full name: Sudta Parakkamodom
investigator title: Principal Investigator
sharing ipd: No