<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/NCT02209246</url>
  </required_header>
  <id_info>
    <org_study_id>2013P001425</org_study_id>
    <nct_id>NCT02209246</nct_id>
  </id_info>
  <brief_title>The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery</brief_title>
  <official_title>The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators of this study would like to see whether providing feedback to patients&#xD;
      regarding their illness behavior/coping strategies, using online questionnaires, improves&#xD;
      patient-physician communication in orthopaedic surgery. The investigators aim to enroll 128&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psychological and sociological factors are important in the human illness experience, but&#xD;
      biomedical factors are the focus of most office visits, particularly in hand surgery. Both&#xD;
      patients and surgeons can feel uncomfortable discussing emotions, stress, and coping&#xD;
      strategies. Detmar et al. randomized patients in an oncology practice to receive feedback on&#xD;
      a HRQL assessment or not during office visits. They observed that feedback on the HRQL&#xD;
      assessment contributed to physicians' awareness of healthy issues and patient-physician&#xD;
      communication. There was a difference in perceived emotional support, but not in overall&#xD;
      satisfaction with the visit[1]. A retrospective study observed in patients with local&#xD;
      prostate cancer, that pre-therapy HRQL assessment is associated with a better sexual&#xD;
      function, sexual bother and bowel function according to post-therapy HRQL scores[2].&#xD;
&#xD;
      The investigators propose a two arm unblended, randomized (1:1) controlled trial to assess&#xD;
      the effect of providing feedback to patients regarding illness behavior/coping strategies&#xD;
      (using Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive&#xD;
      Testing (CAT) instruments) on patient satisfaction and patient-physician communication in&#xD;
      orthopaedic surgery.&#xD;
&#xD;
      If the results of the study suggest that feedback of results from the questionnaires&#xD;
      increases patients' satisfaction, such an intervention may be used in the future to benefit&#xD;
      future patients.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      The aim of this study is to assess the effect of feedback regarding illness behavior measured&#xD;
      with Patient Reported Outcomes Measurement Instrument System - Computerized Adaptive Testing&#xD;
      (PROMIS- CAT) on patient satisfaction.&#xD;
&#xD;
      Primary Null Hypothesis:&#xD;
&#xD;
      There is no difference in satisfaction between patients who receive feedback about their&#xD;
      illness behavior, measured with PROMIS-CAT, compared to patients who do not.&#xD;
&#xD;
      Secondary Null Hypotheses:&#xD;
&#xD;
      There is no difference in patient-physician communication about patient's illness behavior&#xD;
      between patients who receive feedback about their illness behavior, measured with PROMISCAT,&#xD;
      compared to patients who do not.&#xD;
&#xD;
      There are no predictors for patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <primary_purpose>Health Services Research</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>PROMIS CAT Pain Interference</measure>
    <time_frame>1 day</time_frame>
    <description>A computerized assessment of pain interference measured at enrollment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS CAT Pain Behavior</measure>
    <time_frame>1 day</time_frame>
    <description>A computerized assessment of pain behavior measured at enrollment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS CAT Physical Function</measure>
    <time_frame>1 day</time_frame>
    <description>A computerized assessment of physical function measured at enrollment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Interview Satisfaction Scale (MISS-21)</measure>
    <time_frame>1 day</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-physician communication</measure>
    <time_frame>1 day</time_frame>
    <description>The research assistant determines whether the patient's coping strategies (pain interference and pain behavior) were discussed during the encounter or not.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Hand Surgery</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will be comprised of patients who will complete the PROMIS- CAT for pain interference, pain behavior and physical function prior to the encounter with the physician and then will complete the MISS-21 after the encounter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The control group will complete the PROMIS- CAT for pain interference, pain behavior and physical function after the encounter and after completing a satisfaction questionnaire (MISS-21).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROMIS CAT Pain Interference</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROMIS CAT Pain Behavior</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROMIS CAT Physical Function</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MISS-21</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All new patients visiting the Orthopaedic Hand and Upper Extremity Service&#xD;
&#xD;
          -  English fluency and literacy&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18&#xD;
&#xD;
          -  Inability to complete enrollment forms due to any mental status or language problems&#xD;
             (e.g. dementia, head injury, overall illness).&#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>David Ring, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027. Erratum In: JAMA. 2003 Feb 26;289(8):987.</citation>
    <PMID>12479768</PMID>
  </reference>
  <reference>
    <citation>Chamie K, Sadetsky N, Litwin MS. Physician assessment of pretreatment functional status: a process-outcomes link. J Urol. 2011 Apr;185(4):1229-33. doi: 10.1016/j.juro.2010.11.087. Epub 2011 Feb 22.</citation>
    <PMID>21334026</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 1, 2014</last_update_submitted>
  <last_update_submitted_qc>August 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>David C. Ring, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Illness Behavior</mesh_term>
  </condition_browse>
  <!-- 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/NCT02209246
org study id: 2013P001425
nct id: NCT02209246
lead sponsor: 
has dmc: No
The investigators of this study would like to see whether providing feedback to patients
      regarding their illness behavior/coping strategies, using online questionnaires, improves
      patient-physician communication in orthopaedic surgery. The investigators aim to enroll 128
      patients.
Psychological and sociological factors are important in the human illness experience, but
      biomedical factors are the focus of most office visits, particularly in hand surgery. Both
      patients and surgeons can feel uncomfortable discussing emotions, stress, and coping
      strategies. Detmar et al. randomized patients in an oncology practice to receive feedback on
      a HRQL assessment or not during office visits. They observed that feedback on the HRQL
      assessment contributed to physicians' awareness of healthy issues and patient-physician
      communication. There was a difference in perceived emotional support, but not in overall
      satisfaction with the visit[1]. A retrospective study observed in patients with local
      prostate cancer, that pre-therapy HRQL assessment is associated with a better sexual
      function, sexual bother and bowel function according to post-therapy HRQL scores[2].

      The investigators propose a two arm unblended, randomized (1:1) controlled trial to assess
      the effect of providing feedback to patients regarding illness behavior/coping strategies
      (using Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive
      Testing (CAT) instruments) on patient satisfaction and patient-physician communication in
      orthopaedic surgery.

      If the results of the study suggest that feedback of results from the questionnaires
      increases patients' satisfaction, such an intervention may be used in the future to benefit
      future patients.

      Aim:

      The aim of this study is to assess the effect of feedback regarding illness behavior measured
      with Patient Reported Outcomes Measurement Instrument System - Computerized Adaptive Testing
      (PROMIS- CAT) on patient satisfaction.

      Primary Null Hypothesis:

      There is no difference in satisfaction between patients who receive feedback about their
      illness behavior, measured with PROMIS-CAT, compared to patients who do not.

      Secondary Null Hypotheses:

      There is no difference in patient-physician communication about patient's illness behavior
      between patients who receive feedback about their illness behavior, measured with PROMISCAT,
      compared to patients who do not.

      There are no predictors for patient satisfaction.
allocation: Randomized
primary purpose: Health Services Research
measure: PROMIS CAT Pain Interference
time frame: 1 day
description: A computerized assessment of pain interference measured at enrollment
measure: PROMIS CAT Pain Behavior
time frame: 1 day
description: A computerized assessment of pain behavior measured at enrollment
measure: PROMIS CAT Physical Function
time frame: 1 day
description: A computerized assessment of physical function measured at enrollment
measure: Medical Interview Satisfaction Scale (MISS-21)
time frame: 1 day
description: Questionnaire
measure: Patient-physician communication
time frame: 1 day
description: The research assistant determines whether the patient's coping strategies (pain interference and pain behavior) were discussed during the encounter or not.
arm group label: Intervention
arm group type: Experimental
description: The intervention group will be comprised of patients who will complete the PROMIS- CAT for pain interference, pain behavior and physical function prior to the encounter with the physician and then will complete the MISS-21 after the encounter.
arm group label: Control
arm group type: Experimental
description: The control group will complete the PROMIS- CAT for pain interference, pain behavior and physical function after the encounter and after completing a satisfaction questionnaire (MISS-21).
intervention type: Other
intervention name: PROMIS CAT Pain Interference
arm group label: Control
arm group label: Intervention
intervention type: Other
intervention name: PROMIS CAT Pain Behavior
arm group label: Control
arm group label: Intervention
intervention type: Other
intervention name: PROMIS CAT Physical Function
arm group label: Control
arm group label: Intervention
intervention type: Other
intervention name: MISS-21
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Ring, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
citation: Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027. Erratum In: JAMA. 2003 Feb 26;289(8):987.
PMID: 12479768
citation: Chamie K, Sadetsky N, Litwin MS. Physician assessment of pretreatment functional status: a process-outcomes link. J Urol. 2011 Apr;185(4):1229-33. doi: 10.1016/j.juro.2010.11.087. Epub 2011 Feb 22.
PMID: 21334026
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: David C. Ring, MD
investigator title: Principal Investigator
mesh term: Illness Behavior