<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/NCT03011840</url>
  </required_header>
  <id_info>
    <org_study_id>Project no 1775</org_study_id>
    <nct_id>NCT03011840</nct_id>
  </id_info>
  <brief_title>Effect of Patient Information Leaflet on Working Pattern and Patient Satisfaction Level for Day Care Surgeries.</brief_title>
  <official_title>Effect of Patient Information Leaflet on Working Pattern and Patient Satisfaction Level in a Busy Indian Day Care Operative Theatre Complex</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tata Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tata Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to understand the benefits of imparting pre operative instructions through&#xD;
      written leaflets. The influence on the number of avoidable postponements and delay is also&#xD;
      studied.The study is restricted to patients undergoing Head &amp; Neck procedures under General&#xD;
      Anaesthesia, at the minor OT complex at Tata Memorial Hospital&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION:&#xD;
&#xD;
      Patient Information is one of the key determinants of patient satisfaction. Adequate&#xD;
      information about the disease condition, treatment plan, waiting times and 'what to do next'&#xD;
      affects patients' overall satisfaction level. Good quality information not only reduces&#xD;
      patient anxiety and stress, but also reduces unreasonable expectations and misconceptions.&#xD;
      Patient satisfaction has always remained an important and commonly used indicator for&#xD;
      measuring the quality in health care.&#xD;
&#xD;
      In the recent years there is a gradual upward trend in day care surgeries all across the&#xD;
      globe; an estimated 83% of the surgeries in the United States being performed on an&#xD;
      ambulatory basis. In India, about 20 percent of all surgical procedures are performed on&#xD;
      outpatients. It is estimated that by 2020, 75 percent of all surgical operations in India&#xD;
      will be carried out in ambulatory surgery centers. The increasing trend of ambulatory&#xD;
      surgeries has emerged from advances in anesthesia and surgical techniques. Patient&#xD;
      information and effective communication is critical in these surgeries especially the ones&#xD;
      that need General Anesthesia.&#xD;
&#xD;
      Provision of information is one of the mainstays of effective day surgery management. This&#xD;
      needs to cover not only what to do before and after surgery, but also what will happen on the&#xD;
      day of surgery. There are several ways of providing information like written information,&#xD;
      using a video, over telephone or by patient interviews before and after surgery. Verbal&#xD;
      information alone is inadequate and must be reinforced with well-presented printed material.&#xD;
&#xD;
      Tata Memorial Hospital is a premier tertiary level cancer hospital in India. Around 140-150&#xD;
      patients undergo minor surgical procedures (diagnostic and therapeutic) in the Minor OT&#xD;
      complex every day. About 30-40% of surgeries belong to the Head &amp; Neck region alone.About&#xD;
      40-50% of these surgeries are done under general anesthesia. At present the communication&#xD;
      with patients in the busy outpatient department is mainly verbal. Due to time constrains,&#xD;
      lack of a responsible attendant with the patient, important information with respect to the&#xD;
      day care procedure is often not effectively delivered. This leads to patients not following&#xD;
      instruction adequately with respect to starvation, medications to be taken on the day of the&#xD;
      procedure and also not carrying all essential documents. This leads to delays, rescheduling&#xD;
      of cases and rarely postponement of procedures.&#xD;
&#xD;
      Does an information leaflet provide an effective way of communication in the peri-procedure&#xD;
      period? Will it help in better information delivery and hence reduce the number of avoidable&#xD;
      postponements and delay. And does this translate to better patient satisfaction is want this&#xD;
      study aims to see. The study is restricted to patients undergoing Head &amp; Neck procedures&#xD;
      under general anesthesia, as they form the major bulk of patients in our minor OT complex and&#xD;
      for logistic reasons to start with a defined group of patients.&#xD;
&#xD;
      AIMS AND OBJECTIVES:&#xD;
&#xD;
        1. To reduce postponement of cases due to lack of information to patients prior to the&#xD;
           procedure.&#xD;
&#xD;
        2. To compare satisfaction levels between patients , before and after introduction of&#xD;
           information leaflet&#xD;
&#xD;
      Primary end point:&#xD;
&#xD;
      To reduce postponement of cases due to lack of information to patients prior to the&#xD;
      procedure.&#xD;
&#xD;
      Secondary end point To compare satisfaction levels between patients, before and after&#xD;
      introduction of information leaflet.&#xD;
&#xD;
      Design of the study: Intervention&#xD;
&#xD;
      MATERIAL AND METHODS&#xD;
&#xD;
      After Institutional Review Board approval, all adult patients meeting inclusion criteria and&#xD;
      undergoing surgeries in the Minor operation theater 'OT' complex during a 5 month period will&#xD;
      be enrolled in the study. The study will be done in two parts.&#xD;
&#xD;
      In the First half of study- planned over 2 months (Jan - Feb), feedback forms will be&#xD;
      collected from patients at the end of minor 'OT' procedure. All patients, meeting inclusion&#xD;
      criteria, at the end of the procedure prior to discharge from the minor 'OT' will be&#xD;
      explained about the study and they shall be given a feedback form to be filled and submitted.&#xD;
      Also the number of postponement or rescheduling of cases will be noted.&#xD;
&#xD;
      Postponement or rescheduling of case is defined as an event when the patient who is called&#xD;
      for his turn in minor 'OT' is deferred for any amount of time in account of starvation not&#xD;
      adequate, investigations not brought, medications not taken as prescribed.Any postponement in&#xD;
      view of awaiting opinion form senior consultant , special equipment or any investigations&#xD;
      called in view of patients clinical conditions which was not anticipated in the Out Patient&#xD;
      Department 'OPD' by the surgical colleague, or due to lack of OT time will not be included.&#xD;
&#xD;
      After the initial collection of feedback over 2 months, the patient information leaflet (PIL)&#xD;
      will be handed over to all patients planned for procedure in the minor 'OT' complex (Second&#xD;
      half of study). This leaflet will be handed over by the attending doctor in the Head neck&#xD;
      'OPD'. The checklist pertaining to counselling at the Head neck 'OPD' will be ticked after&#xD;
      they are carried out. The patient will be instructed to read leaflet carefully and carry the&#xD;
      leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the&#xD;
      'PIL' would be carried out by all concerned including the surgical, anesthesia and nursing&#xD;
      team. A period of 1 month will be allowed to streamline the use of patient information&#xD;
      leaflet.&#xD;
&#xD;
      In the subsequent 2 months,Apr- May , the impact of use of 'PIL' will be assessed. Firstly by&#xD;
      noting the number of postponement or rescheduling of cases. In addition all patients meeting&#xD;
      inclusion criteria will be given the feedback form. at the end of their procedure in minor&#xD;
      'OT'.&#xD;
&#xD;
      For patients coming to minor 'OT' without a patient information leaflet- one would ascertain&#xD;
      if the leaflet was handed in 'OPD' and not brought to minor OT or if the leaflet was not&#xD;
      handed at all. The numbers of such misses will be recorded.Patients who did not get the&#xD;
      leaflet in the 'OPD' will be excluded from study.&#xD;
&#xD;
      Sample size calculation:&#xD;
&#xD;
      From the investigator's preliminary review of postponement rate at the study center is around&#xD;
      20%. The investigators aim for a reduction in postponement by 50%. Group sample sizes of 199&#xD;
      in group 1 and 199 in group 2 achieve 80.007% power to detect a difference between the group&#xD;
      proportions of -0.1000. The proportion in group 1 (the treatment group) is assumed to be&#xD;
      0.2000 under the null hypothesis and 0.1000 under the alternative hypothesis. The proportion&#xD;
      in group 2 (the control group) is 0.2000. The test statistic used is the two-sided Z-Test&#xD;
      with pooled variance. The significance level of the test is 0.0500.Considering a 20% loss to&#xD;
      follow up from 'OPD' to minor 'OT', the sample size needed is 480 patients.On an average at&#xD;
      least 250 patients of head neck patients undergo procedure under general anesthesia, per&#xD;
      month (12-15 patients /day x 20 working days). With due consideration of our inclusion&#xD;
      criteria, a two month recruitment period before and after the intervention should be&#xD;
      adequate.&#xD;
&#xD;
      MEASUREMENTS&#xD;
&#xD;
        -  No. of cases postponed before and after the introduction of the leaflet and reasons&#xD;
           behind them&#xD;
&#xD;
        -  Primary data collected will be patient satisfaction levels after the procedure (both pre&#xD;
           and post 'PIL') on a 5 point Likert scale (Ranging from very poor = 0 to Excellent = 4)&#xD;
&#xD;
        -  No of patients who did not receive the patient information leaflet in the' OPD'&#xD;
&#xD;
        -  No of patients who received the Patient information leaflet but did not get it along to&#xD;
           the minor OT&#xD;
&#xD;
      STATISTICAL ANALYSIS All Data will be analyzed using Statistical Analysis Software Package&#xD;
      (SPSS) software. Likert scores will be treated as ordinal data. Proportions will be compared&#xD;
      using chi square analysis. Additionally Multivariate logistic regression analysis will be&#xD;
      used to assess the contribution of possible covariates, including age sex and patient&#xD;
      knowledge on patient satisfaction. For all data P-value &lt; 0.05 will be considered as&#xD;
      statistical significant&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">December 6, 2017</completion_date>
  <primary_completion_date type="Actual">June 23, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period</measure>
    <time_frame>On scheduled minor operative procedure day</time_frame>
    <description>Cases postponed will be recorded and those caused due to lack of information of basic instruction to be followed prior to a procedure under GA will be recorded as an event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction About Information With Respect to Instructions to be Followed</measure>
    <time_frame>On scheduled minor operative procedure day</time_frame>
    <description>Patients satisfaction with respect to instruction to be followed with administration of GA will be captured on a five point Likert scale -(5-Excellent, 4-Very good, 3-Good, 2-Poor, 1-Very poor)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">449</enrollment>
  <condition>Patient Compliance</condition>
  <arm_group>
    <arm_group_label>Pre intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.&#xD;
Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information leaflet</intervention_name>
    <description>Patient information leaflet with instructions to be carried out before procedure under general anesthesia</description>
    <arm_group_label>Post Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All adult patients (&gt; 18yrs), ASA I-III, undergoing elective therapeutic/diagnostic Head &amp;&#xD;
        Neck surgeries under General Anaesthesiain the Minor OT complex and discharged on the same&#xD;
        day will be included. The surgeries will include Head &amp; Neck surgeries like DL scopies,&#xD;
        laser surgeries, EUA, excision biopsies etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients refusing to take part in study&#xD;
&#xD;
          2. Patients undergoing emergency surgeries&#xD;
&#xD;
          3. ASA IV patients, or high risk patients planned for admission&#xD;
&#xD;
          4. Admitted patients for minor OT procedure&#xD;
&#xD;
          5. Patients not getting the Information leaflet due to any reason (in 2nd half of study)&#xD;
&#xD;
          6. Patient and his attendant, both illiterate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sumitra G Bakshi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor, Department of Anesthesia, Critical Care and Pain</affiliation>
  </overall_official>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>November 5, 2018</results_first_submitted>
  <results_first_submitted_qc>September 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2019</results_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tata Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Dr Sumitra G Bakshi</investigator_full_name>
    <investigator_title>Professor and Anesthetist</investigator_title>
  </responsible_party>
  <keyword>Patient education handout</keyword>
  <keyword>Patient satisfaction</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03011840/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03011840/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pre Intervention</title>
          <description>In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.&#xD;
Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed.</description>
        </group>
        <group group_id="P2">
          <title>Post Intervention</title>
          <description>In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.&#xD;
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="232"/>
                <participants group_id="P2" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="232"/>
                <participants group_id="P2" count="196"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not received PIL in post PIL phase</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>For primary endpoint -Total no of patients who underwent procedure under GA and the no of postponements in the minor OT in the given time frame was captured. All patients were not enrolled in the feedback process.&#xD;
For secondary endpoint - patients were enrolled after screening, consenting and feedback was collected from the them</population>
      <group_list>
        <group group_id="B1">
          <title>Pre Intervention</title>
          <description>In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.&#xD;
Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed.</description>
        </group>
        <group group_id="B2">
          <title>Post Intervention</title>
          <description>In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.&#xD;
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="232"/>
            <count group_id="B2" value="196"/>
            <count group_id="B3" value="428"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="232"/>
                    <count group_id="B2" value="196"/>
                    <count group_id="B3" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>18-44 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>44-59 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60 years and above</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Data missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="232"/>
                    <count group_id="B2" value="196"/>
                    <count group_id="B3" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="176"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="324"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Data missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="232"/>
                    <count group_id="B2" value="196"/>
                    <count group_id="B3" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Illiterate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>School</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Graduate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post Graduate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Data missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Person filling form</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="232"/>
                    <count group_id="B2" value="196"/>
                    <count group_id="B3" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Patient</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Attendent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="189"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Data missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period</title>
        <description>Cases postponed will be recorded and those caused due to lack of information of basic instruction to be followed prior to a procedure under GA will be recorded as an event.</description>
        <time_frame>On scheduled minor operative procedure day</time_frame>
        <population>Number participants analysed depends upon the number of patients visited to the minor ot complex during assigned time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Pre Intervention</title>
            <description>In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.&#xD;
Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed.</description>
          </group>
          <group group_id="O2">
            <title>Post Intervention</title>
            <description>In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.&#xD;
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period</title>
          <description>Cases postponed will be recorded and those caused due to lack of information of basic instruction to be followed prior to a procedure under GA will be recorded as an event.</description>
          <population>Number participants analysed depends upon the number of patients visited to the minor ot complex during assigned time period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="472"/>
                <count group_id="O2" value="573"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction About Information With Respect to Instructions to be Followed</title>
        <description>Patients satisfaction with respect to instruction to be followed with administration of GA will be captured on a five point Likert scale -(5-Excellent, 4-Very good, 3-Good, 2-Poor, 1-Very poor)</description>
        <time_frame>On scheduled minor operative procedure day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pre Intervention</title>
            <description>In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.&#xD;
Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed.</description>
          </group>
          <group group_id="O2">
            <title>Post Intervention</title>
            <description>In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.&#xD;
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction About Information With Respect to Instructions to be Followed</title>
          <description>Patients satisfaction with respect to instruction to be followed with administration of GA will be captured on a five point Likert scale -(5-Excellent, 4-Very good, 3-Good, 2-Poor, 1-Very poor)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="232"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Info about instructions to follow before surgery</title>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Data missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Info about instructions to follow after surgery</title>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Data missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours</time_frame>
      <desc>No adverse events noted</desc>
      <group_list>
        <group group_id="E1">
          <title>Pre Intervention</title>
          <description>prior to introduction of patient information leaflet</description>
        </group>
        <group group_id="E2">
          <title>Post Intervention</title>
          <description>after introduction of patient information leaflet</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>No adverse events noted</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Disease specific information not incorporated&#xD;
Did not assess the patient anxiety regarding the PIL</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Sumitra Bakshi</name_or_title>
      <organization>Tata Memorial Hospital, Mumbai</organization>
      <phone>+912224177058</phone>
      <email>sumitrabakshi@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03011840
org study id: Project no 1775
nct id: NCT03011840
lead sponsor: 
has dmc: Yes
This study aims to understand the benefits of imparting pre operative instructions through
      written leaflets. The influence on the number of avoidable postponements and delay is also
      studied.The study is restricted to patients undergoing Head & Neck procedures under General
      Anaesthesia, at the minor OT complex at Tata Memorial Hospital
INTRODUCTION:

      Patient Information is one of the key determinants of patient satisfaction. Adequate
      information about the disease condition, treatment plan, waiting times and 'what to do next'
      affects patients' overall satisfaction level. Good quality information not only reduces
      patient anxiety and stress, but also reduces unreasonable expectations and misconceptions.
      Patient satisfaction has always remained an important and commonly used indicator for
      measuring the quality in health care.

      In the recent years there is a gradual upward trend in day care surgeries all across the
      globe; an estimated 83% of the surgeries in the United States being performed on an
      ambulatory basis. In India, about 20 percent of all surgical procedures are performed on
      outpatients. It is estimated that by 2020, 75 percent of all surgical operations in India
      will be carried out in ambulatory surgery centers. The increasing trend of ambulatory
      surgeries has emerged from advances in anesthesia and surgical techniques. Patient
      information and effective communication is critical in these surgeries especially the ones
      that need General Anesthesia.

      Provision of information is one of the mainstays of effective day surgery management. This
      needs to cover not only what to do before and after surgery, but also what will happen on the
      day of surgery. There are several ways of providing information like written information,
      using a video, over telephone or by patient interviews before and after surgery. Verbal
      information alone is inadequate and must be reinforced with well-presented printed material.

      Tata Memorial Hospital is a premier tertiary level cancer hospital in India. Around 140-150
      patients undergo minor surgical procedures (diagnostic and therapeutic) in the Minor OT
      complex every day. About 30-40% of surgeries belong to the Head & Neck region alone.About
      40-50% of these surgeries are done under general anesthesia. At present the communication
      with patients in the busy outpatient department is mainly verbal. Due to time constrains,
      lack of a responsible attendant with the patient, important information with respect to the
      day care procedure is often not effectively delivered. This leads to patients not following
      instruction adequately with respect to starvation, medications to be taken on the day of the
      procedure and also not carrying all essential documents. This leads to delays, rescheduling
      of cases and rarely postponement of procedures.

      Does an information leaflet provide an effective way of communication in the peri-procedure
      period? Will it help in better information delivery and hence reduce the number of avoidable
      postponements and delay. And does this translate to better patient satisfaction is want this
      study aims to see. The study is restricted to patients undergoing Head & Neck procedures
      under general anesthesia, as they form the major bulk of patients in our minor OT complex and
      for logistic reasons to start with a defined group of patients.

      AIMS AND OBJECTIVES:

        1. To reduce postponement of cases due to lack of information to patients prior to the
           procedure.

        2. To compare satisfaction levels between patients , before and after introduction of
           information leaflet

      Primary end point:

      To reduce postponement of cases due to lack of information to patients prior to the
      procedure.

      Secondary end point To compare satisfaction levels between patients, before and after
      introduction of information leaflet.

      Design of the study: Intervention

      MATERIAL AND METHODS

      After Institutional Review Board approval, all adult patients meeting inclusion criteria and
      undergoing surgeries in the Minor operation theater 'OT' complex during a 5 month period will
      be enrolled in the study. The study will be done in two parts.

      In the First half of study- planned over 2 months (Jan - Feb), feedback forms will be
      collected from patients at the end of minor 'OT' procedure. All patients, meeting inclusion
      criteria, at the end of the procedure prior to discharge from the minor 'OT' will be
      explained about the study and they shall be given a feedback form to be filled and submitted.
      Also the number of postponement or rescheduling of cases will be noted.

      Postponement or rescheduling of case is defined as an event when the patient who is called
      for his turn in minor 'OT' is deferred for any amount of time in account of starvation not
      adequate, investigations not brought, medications not taken as prescribed.Any postponement in
      view of awaiting opinion form senior consultant , special equipment or any investigations
      called in view of patients clinical conditions which was not anticipated in the Out Patient
      Department 'OPD' by the surgical colleague, or due to lack of OT time will not be included.

      After the initial collection of feedback over 2 months, the patient information leaflet (PIL)
      will be handed over to all patients planned for procedure in the minor 'OT' complex (Second
      half of study). This leaflet will be handed over by the attending doctor in the Head neck
      'OPD'. The checklist pertaining to counselling at the Head neck 'OPD' will be ticked after
      they are carried out. The patient will be instructed to read leaflet carefully and carry the
      leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the
      'PIL' would be carried out by all concerned including the surgical, anesthesia and nursing
      team. A period of 1 month will be allowed to streamline the use of patient information
      leaflet.

      In the subsequent 2 months,Apr- May , the impact of use of 'PIL' will be assessed. Firstly by
      noting the number of postponement or rescheduling of cases. In addition all patients meeting
      inclusion criteria will be given the feedback form. at the end of their procedure in minor
      'OT'.

      For patients coming to minor 'OT' without a patient information leaflet- one would ascertain
      if the leaflet was handed in 'OPD' and not brought to minor OT or if the leaflet was not
      handed at all. The numbers of such misses will be recorded.Patients who did not get the
      leaflet in the 'OPD' will be excluded from study.

      Sample size calculation:

      From the investigator's preliminary review of postponement rate at the study center is around
      20%. The investigators aim for a reduction in postponement by 50%. Group sample sizes of 199
      in group 1 and 199 in group 2 achieve 80.007% power to detect a difference between the group
      proportions of -0.1000. The proportion in group 1 (the treatment group) is assumed to be
      0.2000 under the null hypothesis and 0.1000 under the alternative hypothesis. The proportion
      in group 2 (the control group) is 0.2000. The test statistic used is the two-sided Z-Test
      with pooled variance. The significance level of the test is 0.0500.Considering a 20% loss to
      follow up from 'OPD' to minor 'OT', the sample size needed is 480 patients.On an average at
      least 250 patients of head neck patients undergo procedure under general anesthesia, per
      month (12-15 patients /day x 20 working days). With due consideration of our inclusion
      criteria, a two month recruitment period before and after the intervention should be
      adequate.

      MEASUREMENTS

        -  No. of cases postponed before and after the introduction of the leaflet and reasons
           behind them

        -  Primary data collected will be patient satisfaction levels after the procedure (both pre
           and post 'PIL') on a 5 point Likert scale (Ranging from very poor = 0 to Excellent = 4)

        -  No of patients who did not receive the patient information leaflet in the' OPD'

        -  No of patients who received the Patient information leaflet but did not get it along to
           the minor OT

      STATISTICAL ANALYSIS All Data will be analyzed using Statistical Analysis Software Package
      (SPSS) software. Likert scores will be treated as ordinal data. Proportions will be compared
      using chi square analysis. Additionally Multivariate logistic regression analysis will be
      used to assess the contribution of possible covariates, including age sex and patient
      knowledge on patient satisfaction. For all data P-value < 0.05 will be considered as
      statistical significant
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period
time frame: On scheduled minor operative procedure day
description: Cases postponed will be recorded and those caused due to lack of information of basic instruction to be followed prior to a procedure under GA will be recorded as an event.
measure: Satisfaction About Information With Respect to Instructions to be Followed
time frame: On scheduled minor operative procedure day
description: Patients satisfaction with respect to instruction to be followed with administration of GA will be captured on a five point Likert scale -(5-Excellent, 4-Very good, 3-Good, 2-Poor, 1-Very poor)
arm group label: Pre intervention
arm group type: No Intervention
description: In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.
Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed.
arm group label: Post Intervention
arm group type: Experimental
description: In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.
intervention type: Other
intervention name: Information leaflet
description: Patient information leaflet with instructions to be carried out before procedure under general anesthesia
arm group label: Post Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sumitra G Bakshi
role: Principal Investigator
affiliation: Professor, Department of Anesthesia, Critical Care and Pain
responsible party type: Principal Investigator
investigator affiliation: Tata Memorial Hospital
investigator full name: Dr Sumitra G Bakshi
investigator title: Professor and Anesthetist
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Disease specific information not incorporated
Did not assess the patient anxiety regarding the PIL
point of contact: 