<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/NCT01693094</url>
  </required_header>
  <id_info>
    <org_study_id>2012P002281</org_study_id>
    <nct_id>NCT01693094</nct_id>
  </id_info>
  <brief_title>A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome</brief_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators plan a prospective randomized controlled study that compares the treatment&#xD;
      decisions made by patients who receive decision aids, as compared to patients treated with&#xD;
      usual care and the American Society for Surgery of the Hand brochures. The investigators&#xD;
      expect to enroll 126 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Decision aids are tools that help patients participate in making decisions by providing&#xD;
      detailed, specific, and personalized information regarding the benefits and risks of various&#xD;
      potential treatment options for a diagnosis. Decision aids can reduce the level of&#xD;
      uncertainty and mental anguish associated with choosing a particular course of action, i.e.&#xD;
      'decisional conflict'. The most common manifestations of decisional conflict include&#xD;
      verbalized uncertainty about choices or undesired consequences of alternatives, vacillation&#xD;
      between choices, and delayed decision making.&#xD;
&#xD;
      Besides the advantages of decision aids in the process of decision-making, the literature is&#xD;
      not conclusive about the effect of decision aids on patient satisfaction. Of the 86&#xD;
      randomized controlled trials identified by authors Stacey et al., eleven studies measured&#xD;
      satisfaction. Of these, four studies reported that people exposed to decision aids had higher&#xD;
      satisfaction with their choice compared to usual care, and the remaining seven reported no&#xD;
      statistically significant difference.&#xD;
&#xD;
      Studies that have directly investigated the effect of decision aids in orthopaedic practice&#xD;
      are limited and further study is necessary to determine the best way to implement decision&#xD;
      aids in a clinical orthopedic practice. 7-12 Randomized trials evaluating the impact of&#xD;
      decision aids on patient knowledge, decisional conflict, satisfaction, and outcomes may have&#xD;
      substantial impact in hand surgery where most treatments are elective and address quality of&#xD;
      life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Not adequate number of staff to continue study at the moment.&#xD;
  </why_stopped>
  <start_date type="Actual">June 10, 2014</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decision conflict scale (DCS)</measure>
    <time_frame>At enrollment</time_frame>
    <description>Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Decision conflict scale (DCS) at 6 weeks</measure>
    <time_frame>At 6-week follow-up</time_frame>
    <description>Change from baseline in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Decision conflict scale (DCS) at 6 months</measure>
    <time_frame>At 6 month follow-up</time_frame>
    <description>6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>11-point ordinal satisfaction scale</measure>
    <time_frame>At enrollment</time_frame>
    <description>The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>11-point ordinal satisfaction scale</measure>
    <time_frame>At enrollment</time_frame>
    <description>11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge questionnaire</measure>
    <time_frame>At Enrollment</time_frame>
    <description>The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage of decision making</measure>
    <time_frame>At Enrollment</time_frame>
    <description>The Stage of decision making is meant to gauge patients' progress in making a treatment decision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision Self-efficacy Scale</measure>
    <time_frame>At enrollment</time_frame>
    <description>The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>At Enrollment</time_frame>
    <description>The Acceptability questionnaire measures the acceptability of the decision aid, including the content of the decision aid.&#xD;
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Self efficacy Questionnaire (PSEQ)</measure>
    <time_frame>At enrollment</time_frame>
    <description>The PSEQ measures the efficacy of patients regarding pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)</measure>
    <time_frame>At enrollment</time_frame>
    <description>The Quick-DASH measures the patient's ability to do following activities in the week before a visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5D-5L Questionnaire (EQ-5D-5L)</measure>
    <time_frame>At Enrollment</time_frame>
    <description>EQ-5D-5L measures the health outcome of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision Regret scale</measure>
    <time_frame>At the 6-month follow-up</time_frame>
    <description>The Decision Regret Scale measures distress or remorse after a health care decision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 11-point ordinal satisfaction scale at 6 weeks</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-week change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 11-point ordinal satisfaction scale at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>6-month change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 11-point ordinal satisfaction scale at 6 weeks</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-week change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 11-point ordinal satisfaction scale at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>6-month change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Stage of decision making at 6 weeks</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-week change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Stage of decision making at 6 months</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-month change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Knowledge questionnaire at 6 weeks</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-week change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Knowledge questionnaire at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>6-month change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Decision Self-efficacy Scale at 6 weeks</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-week change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in the Decision Self-Efficacy Scale at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>6-month change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in the Acceptability questionnaire at 6 weeks</measure>
    <time_frame>At the 6-week follow-up</time_frame>
    <description>6-week change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid.&#xD;
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in the Acceptability questionnaire at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>6-month change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid.&#xD;
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-week change in the PSEQ, which measures the efficacy of patients regarding pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>6-month change in the PSEQ, which measures the efficacy of patients regarding pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 weeks</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks</measure>
    <time_frame>At the 6 week follow-up</time_frame>
    <description>6-week change in the EQ-5D-5L, which measures the health outcome of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>6-month change in the EQ-5D-5L, which measures the health outcome of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Decision Regret scale at 6 months</measure>
    <time_frame>At the 6 month follow-up</time_frame>
    <description>Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Trapeziometacarpal Arthrosis</condition>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Cubital Tunnel Syndrome</condition>
  <condition>Distal Radius Fractures</condition>
  <condition>Trigger Finger</condition>
  <arm_group>
    <arm_group_label>No decision aid</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decision Aid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One cohort will receive a decision aid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>Cohort I will be managed with a decision aid (henceforth &quot;DA&quot;), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them.</description>
    <arm_group_label>Decision Aid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and above&#xD;
&#xD;
          -  Diagnosis of moderate or severe:&#xD;
&#xD;
             2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous interventions for CTS or TF&#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>Neal Chen, MD</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>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>June 11, 2023</last_update_submitted>
  <last_update_submitted_qc>June 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Neal Chung-Jen Chen</investigator_full_name>
    <investigator_title>Principal Investigator, Hand Service</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigger Finger Disorder</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Cubital Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</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/NCT01693094
org study id: 2012P002281
nct id: NCT01693094
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators plan a prospective randomized controlled study that compares the treatment
      decisions made by patients who receive decision aids, as compared to patients treated with
      usual care and the American Society for Surgery of the Hand brochures. The investigators
      expect to enroll 126 patients.
Decision aids are tools that help patients participate in making decisions by providing
      detailed, specific, and personalized information regarding the benefits and risks of various
      potential treatment options for a diagnosis. Decision aids can reduce the level of
      uncertainty and mental anguish associated with choosing a particular course of action, i.e.
      'decisional conflict'. The most common manifestations of decisional conflict include
      verbalized uncertainty about choices or undesired consequences of alternatives, vacillation
      between choices, and delayed decision making.

      Besides the advantages of decision aids in the process of decision-making, the literature is
      not conclusive about the effect of decision aids on patient satisfaction. Of the 86
      randomized controlled trials identified by authors Stacey et al., eleven studies measured
      satisfaction. Of these, four studies reported that people exposed to decision aids had higher
      satisfaction with their choice compared to usual care, and the remaining seven reported no
      statistically significant difference.

      Studies that have directly investigated the effect of decision aids in orthopaedic practice
      are limited and further study is necessary to determine the best way to implement decision
      aids in a clinical orthopedic practice. 7-12 Randomized trials evaluating the impact of
      decision aids on patient knowledge, decisional conflict, satisfaction, and outcomes may have
      substantial impact in hand surgery where most treatments are elective and address quality of
      life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Decision conflict scale (DCS)
time frame: At enrollment
description: Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.
measure: Change from baseline in Decision conflict scale (DCS) at 6 weeks
time frame: At 6-week follow-up
description: Change from baseline in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
measure: Change from baseline Decision conflict scale (DCS) at 6 months
time frame: At 6 month follow-up
description: 6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
measure: 11-point ordinal satisfaction scale
time frame: At enrollment
description: The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment
measure: 11-point ordinal satisfaction scale
time frame: At enrollment
description: 11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
measure: Knowledge questionnaire
time frame: At Enrollment
description: The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
measure: Stage of decision making
time frame: At Enrollment
description: The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
measure: Decision Self-efficacy Scale
time frame: At enrollment
description: The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
measure: Acceptability
time frame: At Enrollment
description: The Acceptability questionnaire measures the acceptability of the decision aid, including the content of the decision aid.
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.
measure: Pain Self efficacy Questionnaire (PSEQ)
time frame: At enrollment
description: The PSEQ measures the efficacy of patients regarding pain.
measure: Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
time frame: At enrollment
description: The Quick-DASH measures the patient's ability to do following activities in the week before a visit.
measure: EuroQol-5D-5L Questionnaire (EQ-5D-5L)
time frame: At Enrollment
description: EQ-5D-5L measures the health outcome of the patient.
measure: Decision Regret scale
time frame: At the 6-month follow-up
description: The Decision Regret Scale measures distress or remorse after a health care decision.
measure: Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
time frame: At the 6 week follow-up
description: 6-week change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
measure: Change from baseline in 11-point ordinal satisfaction scale at 6 months
time frame: At the 6 month follow-up
description: 6-month change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
measure: Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
time frame: At the 6 week follow-up
description: 6-week change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
measure: Change from baseline in 11-point ordinal satisfaction scale at 6 months
time frame: At the 6 month follow-up
description: 6-month change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
measure: Change from baseline in Stage of decision making at 6 weeks
time frame: At the 6 week follow-up
description: 6-week change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
measure: Change from baseline in Stage of decision making at 6 months
time frame: At the 6 week follow-up
description: 6-month change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
measure: Change from baseline in the Knowledge questionnaire at 6 weeks
time frame: At the 6 week follow-up
description: 6-week change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
measure: Change from baseline in the Knowledge questionnaire at 6 months
time frame: At the 6 month follow-up
description: 6-month change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
measure: Change from baseline in the Decision Self-efficacy Scale at 6 weeks
time frame: At the 6 week follow-up
description: 6-week change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
measure: Change from the baseline in the Decision Self-Efficacy Scale at 6 months
time frame: At the 6 month follow-up
description: 6-month change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
measure: Change from the baseline in the Acceptability questionnaire at 6 weeks
time frame: At the 6-week follow-up
description: 6-week change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid.
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.
measure: Change from the baseline in the Acceptability questionnaire at 6 months
time frame: At the 6 month follow-up
description: 6-month change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid.
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.
measure: Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks
time frame: At the 6 week follow-up
description: 6-week change in the PSEQ, which measures the efficacy of patients regarding pain.
measure: Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months
time frame: At the 6 month follow-up
description: 6-month change in the PSEQ, which measures the efficacy of patients regarding pain.
measure: Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 weeks
time frame: At the 6 week follow-up
description: 6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
measure: Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months
time frame: At the 6 month follow-up
description: 6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
measure: Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks
time frame: At the 6 week follow-up
description: 6-week change in the EQ-5D-5L, which measures the health outcome of the patient.
measure: Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months
time frame: At the 6 month follow-up
description: 6-month change in the EQ-5D-5L, which measures the health outcome of the patient.
measure: Change in the Decision Regret scale at 6 months
time frame: At the 6 month follow-up
description: Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.
arm group label: No decision aid
arm group type: No Intervention
description: One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
arm group label: Decision Aid
arm group type: Active Comparator
description: One cohort will receive a decision aid.
intervention type: Behavioral
intervention name: Decision Aid
description: Cohort I will be managed with a decision aid (henceforth "DA"), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them.
arm group label: Decision Aid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neal Chen, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Neal Chung-Jen Chen
investigator title: Principal Investigator, Hand Service
mesh term: Trigger Finger Disorder
mesh term: Osteoarthritis
mesh term: Carpal Tunnel Syndrome
mesh term: Cubital Tunnel Syndrome
mesh term: Syndrome
mesh term: Radius Fractures
mesh term: Wrist Fractures