<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/NCT02257554</url>
  </required_header>
  <id_info>
    <org_study_id>2014-287</org_study_id>
    <nct_id>NCT02257554</nct_id>
  </id_info>
  <brief_title>Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery</brief_title>
  <official_title>Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this study are to assess concordance between the patient-surgeon pair regarding&#xD;
      expectations of lumbar spine surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain is a prevalent medical condition afflicting primarily older adults but&#xD;
      affecting all age groups and due to acute and non-acute diagnoses. Multiple possible&#xD;
      conservative therapies exist; however, their major drawback is that the time required to&#xD;
      advance therapy is often prolonged and accompanied by persistent disability and psychological&#xD;
      suffering. Thus, some patients seek surgery after exhausting other therapies and some&#xD;
      patients seek surgery earlier in their course. For both groups, decisions to undergo surgery&#xD;
      are based on personal circumstances, perspectives, and expectations of outcome. Prior studies&#xD;
      have shown that patients typically have high expectations of orthopedic surgery. Although&#xD;
      high aspirations can be motivating, they also may predispose to poor outcomes if they are&#xD;
      unrealistic and cause patients to become discouraged with recuperation time and ignore&#xD;
      recommended lifestyle changes that avert progression of disease. Expectations that are too&#xD;
      low, conversely, also may predispose to poor outcomes if patients lack motivation to&#xD;
      participate in rehabilitation and to follow postop precautions. In order to achieve maximum&#xD;
      benefit from surgery, patients and surgeons need to share an understanding of what is&#xD;
      possible, probable, and realistic, and to join together and work toward the same goals. The&#xD;
      primary objective of this proposed cross-sectional study is to assess the concordance between&#xD;
      patients and their surgeons regarding expectations of lumbar spine surgery. Patients&#xD;
      scheduled for lumbar surgery will be dichotomized according to whether they have acute versus&#xD;
      non-acute conditions. Several days before surgery patients will complete the validated Lumbar&#xD;
      Spine Surgery Expectations Survey measuring their physical and psychological expectations.&#xD;
      Also before surgery their surgeons will complete the surgeon's version of the same survey for&#xD;
      each patient. The main outcome will be a comparison of the concordance within each&#xD;
      patient-surgeon pair according to acute versus non-acute groups based on the concordance&#xD;
      correlation coefficient. Multivariate regression analysis based on the GEE method will be&#xD;
      used to assess covariates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Comparison of Lumbar Spine Surgery Expectations Survey scores for patients and their surgeons.</measure>
    <time_frame>participants will be surveyed before surgery, an expected average of 5 days</time_frame>
    <description>comparison of patients and surgeons responses</description>
  </primary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Lumbar Spine Surgery</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>education</intervention_name>
    <description>Discussion of surgical expectations with patients</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for lumbar spine surgery and their surgeons&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be eligible if they are ≥ 18 years old, speak English, and are scheduled&#xD;
             for non-trauma-related lumbar spine surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded if they have cognitive deficits and cannot provide informed&#xD;
             consent.&#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>Carol A Mancuso, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carol A Mancuso, MD</last_name>
    <phone>212-774-7508</phone>
    <email>mancusoc@hss.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Roland Duculan, MD</last_name>
    <phone>646-714-6046</phone>
    <email>duculanr@hss.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carol A Mancuso, MD</last_name>
      <phone>212-774-7508</phone>
      <email>mancusoc@hss.edu</email>
    </contact>
    <contact_backup>
      <last_name>Roland Duculan, MD</last_name>
      <phone>646-714-6046</phone>
      <email>duculanr@hss.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Federico P Girardi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mancuso CA, Cammisa FP, Sama AA, Hughes AP, Ghomrawi HM, Girardi FP. Development and testing of an expectations survey for patients undergoing lumbar spine surgery. J Bone Joint Surg Am. 2013 Oct 2;95(19):1793-800. doi: 10.2106/JBJS.L.00338.</citation>
    <PMID>24088972</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>expectations</keyword>
  <!-- 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/NCT02257554
org study id: 2014-287
nct id: NCT02257554
lead sponsor: 
has dmc: No
The goals of this study are to assess concordance between the patient-surgeon pair regarding
      expectations of lumbar spine surgery.
Low back pain is a prevalent medical condition afflicting primarily older adults but
      affecting all age groups and due to acute and non-acute diagnoses. Multiple possible
      conservative therapies exist; however, their major drawback is that the time required to
      advance therapy is often prolonged and accompanied by persistent disability and psychological
      suffering. Thus, some patients seek surgery after exhausting other therapies and some
      patients seek surgery earlier in their course. For both groups, decisions to undergo surgery
      are based on personal circumstances, perspectives, and expectations of outcome. Prior studies
      have shown that patients typically have high expectations of orthopedic surgery. Although
      high aspirations can be motivating, they also may predispose to poor outcomes if they are
      unrealistic and cause patients to become discouraged with recuperation time and ignore
      recommended lifestyle changes that avert progression of disease. Expectations that are too
      low, conversely, also may predispose to poor outcomes if patients lack motivation to
      participate in rehabilitation and to follow postop precautions. In order to achieve maximum
      benefit from surgery, patients and surgeons need to share an understanding of what is
      possible, probable, and realistic, and to join together and work toward the same goals. The
      primary objective of this proposed cross-sectional study is to assess the concordance between
      patients and their surgeons regarding expectations of lumbar spine surgery. Patients
      scheduled for lumbar surgery will be dichotomized according to whether they have acute versus
      non-acute conditions. Several days before surgery patients will complete the validated Lumbar
      Spine Surgery Expectations Survey measuring their physical and psychological expectations.
      Also before surgery their surgeons will complete the surgeon's version of the same survey for
      each patient. The main outcome will be a comparison of the concordance within each
      patient-surgeon pair according to acute versus non-acute groups based on the concordance
      correlation coefficient. Multivariate regression analysis based on the GEE method will be
      used to assess covariates.
observational model: Cohort
time perspective: Prospective
measure: Comparison of Lumbar Spine Surgery Expectations Survey scores for patients and their surgeons.
time frame: participants will be surveyed before surgery, an expected average of 5 days
description: comparison of patients and surgeons responses
intervention type: Behavioral
intervention name: education
description: Discussion of surgical expectations with patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carol A Mancuso, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
last name: Carol A Mancuso, MD
phone: 212-774-7508
email: mancusoc@hss.edu
last name: Roland Duculan, MD
phone: 646-714-6046
email: duculanr@hss.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: Mancuso CA, Cammisa FP, Sama AA, Hughes AP, Ghomrawi HM, Girardi FP. Development and testing of an expectations survey for patients undergoing lumbar spine surgery. J Bone Joint Surg Am. 2013 Oct 2;95(19):1793-800. doi: 10.2106/JBJS.L.00338.
PMID: 24088972
responsible party type: Sponsor