<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/NCT02996344</url>
  </required_header>
  <id_info>
    <org_study_id>00061161</org_study_id>
    <nct_id>NCT02996344</nct_id>
  </id_info>
  <brief_title>Suicide Prevention Training for PC Providers-in-training</brief_title>
  <official_title>Suicide Prevention Training for Primary Care Providers-in-training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized control study responds to the need for effective suicide prevention&#xD;
      education/training that is grounded in adult learning theory and advances in education, in&#xD;
      the context of a changing health care landscape where primary care providers are likely to&#xD;
      encounter suicidal individuals. The study will test the effectiveness of suicide prevention&#xD;
      education for providers-in-training by comparing two conditions: 1) A Control learning group:&#xD;
      includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online&#xD;
      via brief videos, and 2) An Experimental learning group: includes didactics plus two&#xD;
      standardized patient (SP) interactions. One Experimental learning group SP interaction will&#xD;
      be in person and the other will be conducted remotely using a secure webcam service (OoVoo).&#xD;
      All SP interactions will be recorded. Both groups will be compared in terms of their suicide&#xD;
      prevention skills using an SP 'test case' at 6-month follow up. The primary research question&#xD;
      is to learn about the impact of practice (though SP simulation) over and above didactics&#xD;
      alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Suicide is a national public health crisis and a critical patient safety issue. Suicide is&#xD;
      the 10th leading cause of death overall and, shockingly, the 2nd leading cause of death in&#xD;
      adolescents and young adults (15-34 years old). 1 A recent U.S. study of suicide reported&#xD;
      that 45% of individuals who died by suicide had contact with primary care services within one&#xD;
      month before their death. 2 Another study found that 80% of youth who died by suicide saw&#xD;
      their primary care provider within the year of their death. 3 Patient safety is compromised&#xD;
      when primary care providers lack the knowledge and skills to assess and respond to patients&#xD;
      at risk for suicide.&#xD;
&#xD;
      This randomized control study responds to the need for effective suicide prevention&#xD;
      education/training that is grounded in adult learning theory and advances in education, in&#xD;
      the context of a changing health care landscape where primary care providers are likely to&#xD;
      encounter suicidal individuals. 4 We will test the effectiveness of suicide prevention&#xD;
      education for providers-in-training by comparing two conditions: 1) A Control learning group:&#xD;
      includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online&#xD;
      via brief videos, and 2) An Experimental learning group: includes didactics plus two&#xD;
      standardized patient (SP) interactions. One Experimental learning group SP interaction will&#xD;
      be in person and the other will be conducted remotely using a secure webcam service (OoVoo).&#xD;
      All SP interactions will be recorded. Both groups will be compared in terms of their suicide&#xD;
      prevention skills using an SP 'test case' at 6-month follow up. The primary research question&#xD;
      is to learn about the impact of practice (though SP simulation) over and above didactics&#xD;
      alone. The hypotheses are as follows:&#xD;
&#xD;
      H1: All subjects will demonstrate improved suicide prevention knowledge from pre to post&#xD;
      didactics and maintain improvement 6 months after didactics.&#xD;
&#xD;
      H2: Subjects in the experimental learning group will report greater satisfaction with the&#xD;
      training, greater self-efficacy in identifying and responding to patients at risk for&#xD;
      suicide, greater intention to use, as well as use of suicide prevention skills.&#xD;
&#xD;
      H3: Subjects in the experimental learning group will also be more skillful in responding to&#xD;
      patients at risk for suicide (in an SP interview, measured by objective observed ratings)&#xD;
      compared to the control learning group 6 months after didactics.&#xD;
&#xD;
      Exploratory Aims: We will examine moderators of outcomes, differences among SP simulations&#xD;
      (i.e., face-to-face vs. telehealth modalities), and if there is growth in improved skills&#xD;
      observed over multiple SP experiences in the experimental learning group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2016</start_date>
  <completion_date type="Actual">June 7, 2018</completion_date>
  <primary_completion_date type="Actual">June 7, 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean score using the Commitment to Living: Primary Care Observational Rating form</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Each participant will be evaluated via standardized patient interactions which are video taped and reliably coded using the Commitment to Living: Primary Care Observational Rating form. Score will range from 0 - 32.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in suicide prevention knowledge</measure>
    <time_frame>1 day following enrollment and 15 days from enrollment</time_frame>
    <description>Participants will complete a 17-item knowledge questionnaire prior to and following the online didactic training. Number of correct responses will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in suicide prevention self-efficacy</measure>
    <time_frame>1 day following enrollment and 15 days from enrollment</time_frame>
    <description>Participants will complete a 20-item 5-point likert scale self-efficacy questionnaire prior to and following the online didactic training. Average responses will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in suicide prevention knowledge</measure>
    <time_frame>15 days from enrollment and through study completion, an average of 6 months</time_frame>
    <description>Participants will complete a 17-item knowledge questionnaire following the online didactic training and end of study. Number of correct responses will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants intending to transfer training to practice</measure>
    <time_frame>15 days from enrollment and through study completion, an average of 6 months</time_frame>
    <description>Participants will complete a 8-item intentions to use training in practice on a 5-item likert scale questionnaire following the online didactic training and end of study. Number of participants who report positive intentions to use the training in practice will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in suicide prevention self-efficacy</measure>
    <time_frame>15 days from enrollment and through study completion, an average of 6 months</time_frame>
    <description>Participants will complete a 20-item 5-point likert scale self-efficacy questionnaire following the online didactic training and end of study. Average responses will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of suicide prevention skills</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Participants will self-report whether they used suicide prevention skills in practice on 0-4 point likert scale, with 0 defined as no use and 4 as frequently used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feedback on training</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Participants will provide feedback on their experience with suicide prevention training on 15 items using a 5-point likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Suicide Prevention</condition>
  <arm_group>
    <arm_group_label>Didactic training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Behavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Didactics and standardized patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos plus two practice standardized patient interactions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Didactic training</intervention_name>
    <description>Six online training modules pertaining to suicide prevention in primary care.</description>
    <arm_group_label>Didactic training</arm_group_label>
    <arm_group_label>Didactics and standardized patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standardized patient interaction</intervention_name>
    <description>Two standardized patient practice interactions - 1 face-to-face, 1 remote/telehealth.</description>
    <arm_group_label>Didactics and standardized patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  trainee in family medicine residency, pediatrics residency, or nurse practitioner&#xD;
             program at URMC.&#xD;
&#xD;
          -  speaks/writes English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  on academic probation&#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>Wendi F Cross, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor of Psychiatry (Psychology) and Pediatrics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.</citation>
    <PMID>24567199</PMID>
  </reference>
  <reference>
    <citation>Bridge JA, Horowitz LM, Fontanella CA, Grupp-Phelan J, Campo JV. Prioritizing research to reduce youth suicide and suicidal behavior. Am J Prev Med. 2014 Sep;47(3 Suppl 2):S229-34. doi: 10.1016/j.amepre.2014.06.001.</citation>
    <PMID>25145744</PMID>
  </reference>
  <reference>
    <citation>Wyzga RE. The effect of air pollution upon mortality: a consideration of distributed lag models. J Am Stat Assoc. 1978;73(363):463-72. doi: 10.1080/01621459.1978.10480035. No abstract available.</citation>
    <PMID>12262745</PMID>
  </reference>
  <reference>
    <citation>Pisani AR, Cross WF, Watts A, Conner K. Evaluation of the Commitment to Living (CTL) curriculum: a 3-hour training for mental health professionals to address suicide risk. Crisis. 2012 Jan 1;33(1):30-8. doi: 10.1027/0227-5910/a000099.</citation>
    <PMID>21940243</PMID>
  </reference>
  <reference>
    <citation>Aiken LS, West SG. Multiple regression: Testing and interpreting interactions. Newbury Park, CA: Sage; 1991.</citation>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Wendi Cross</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide Prevention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996344
org study id: 00061161
nct id: NCT02996344
lead sponsor: 
has dmc: No
This randomized control study responds to the need for effective suicide prevention
      education/training that is grounded in adult learning theory and advances in education, in
      the context of a changing health care landscape where primary care providers are likely to
      encounter suicidal individuals. The study will test the effectiveness of suicide prevention
      education for providers-in-training by comparing two conditions: 1) A Control learning group:
      includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online
      via brief videos, and 2) An Experimental learning group: includes didactics plus two
      standardized patient (SP) interactions. One Experimental learning group SP interaction will
      be in person and the other will be conducted remotely using a secure webcam service (OoVoo).
      All SP interactions will be recorded. Both groups will be compared in terms of their suicide
      prevention skills using an SP 'test case' at 6-month follow up. The primary research question
      is to learn about the impact of practice (though SP simulation) over and above didactics
      alone.
Suicide is a national public health crisis and a critical patient safety issue. Suicide is
      the 10th leading cause of death overall and, shockingly, the 2nd leading cause of death in
      adolescents and young adults (15-34 years old). 1 A recent U.S. study of suicide reported
      that 45% of individuals who died by suicide had contact with primary care services within one
      month before their death. 2 Another study found that 80% of youth who died by suicide saw
      their primary care provider within the year of their death. 3 Patient safety is compromised
      when primary care providers lack the knowledge and skills to assess and respond to patients
      at risk for suicide.

      This randomized control study responds to the need for effective suicide prevention
      education/training that is grounded in adult learning theory and advances in education, in
      the context of a changing health care landscape where primary care providers are likely to
      encounter suicidal individuals. 4 We will test the effectiveness of suicide prevention
      education for providers-in-training by comparing two conditions: 1) A Control learning group:
      includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online
      via brief videos, and 2) An Experimental learning group: includes didactics plus two
      standardized patient (SP) interactions. One Experimental learning group SP interaction will
      be in person and the other will be conducted remotely using a secure webcam service (OoVoo).
      All SP interactions will be recorded. Both groups will be compared in terms of their suicide
      prevention skills using an SP 'test case' at 6-month follow up. The primary research question
      is to learn about the impact of practice (though SP simulation) over and above didactics
      alone. The hypotheses are as follows:

      H1: All subjects will demonstrate improved suicide prevention knowledge from pre to post
      didactics and maintain improvement 6 months after didactics.

      H2: Subjects in the experimental learning group will report greater satisfaction with the
      training, greater self-efficacy in identifying and responding to patients at risk for
      suicide, greater intention to use, as well as use of suicide prevention skills.

      H3: Subjects in the experimental learning group will also be more skillful in responding to
      patients at risk for suicide (in an SP interview, measured by objective observed ratings)
      compared to the control learning group 6 months after didactics.

      Exploratory Aims: We will examine moderators of outcomes, differences among SP simulations
      (i.e., face-to-face vs. telehealth modalities), and if there is growth in improved skills
      observed over multiple SP experiences in the experimental learning group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Mean score using the Commitment to Living: Primary Care Observational Rating form
time frame: through study completion, an average of 6 months
description: Each participant will be evaluated via standardized patient interactions which are video taped and reliably coded using the Commitment to Living: Primary Care Observational Rating form. Score will range from 0 - 32.
measure: Changes in suicide prevention knowledge
time frame: 1 day following enrollment and 15 days from enrollment
description: Participants will complete a 17-item knowledge questionnaire prior to and following the online didactic training. Number of correct responses will be compared.
measure: Changes in suicide prevention self-efficacy
time frame: 1 day following enrollment and 15 days from enrollment
description: Participants will complete a 20-item 5-point likert scale self-efficacy questionnaire prior to and following the online didactic training. Average responses will be compared.
measure: Changes in suicide prevention knowledge
time frame: 15 days from enrollment and through study completion, an average of 6 months
description: Participants will complete a 17-item knowledge questionnaire following the online didactic training and end of study. Number of correct responses will be compared.
measure: Number of participants intending to transfer training to practice
time frame: 15 days from enrollment and through study completion, an average of 6 months
description: Participants will complete a 8-item intentions to use training in practice on a 5-item likert scale questionnaire following the online didactic training and end of study. Number of participants who report positive intentions to use the training in practice will be compared.
measure: Changes in suicide prevention self-efficacy
time frame: 15 days from enrollment and through study completion, an average of 6 months
description: Participants will complete a 20-item 5-point likert scale self-efficacy questionnaire following the online didactic training and end of study. Average responses will be compared.
measure: Use of suicide prevention skills
time frame: through study completion, an average of 6 months
description: Participants will self-report whether they used suicide prevention skills in practice on 0-4 point likert scale, with 0 defined as no use and 4 as frequently used.
measure: Feedback on training
time frame: through study completion, an average of 6 months
description: Participants will provide feedback on their experience with suicide prevention training on 15 items using a 5-point likert scale.
arm group label: Didactic training
arm group type: Active Comparator
description: Behavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos.
arm group label: Didactics and standardized patients
arm group type: Experimental
description: Behavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos plus two practice standardized patient interactions.
intervention type: Other
intervention name: Didactic training
description: Six online training modules pertaining to suicide prevention in primary care.
arm group label: Didactic training
arm group label: Didactics and standardized patients
intervention type: Other
intervention name: Standardized patient interaction
description: Two standardized patient practice interactions - 1 face-to-face, 1 remote/telehealth.
arm group label: Didactics and standardized patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wendi F Cross, PhD
role: Principal Investigator
affiliation: Associate Professor of Psychiatry (Psychology) and Pediatrics
facility: 
country: United States
citation: Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.
PMID: 24567199
citation: Bridge JA, Horowitz LM, Fontanella CA, Grupp-Phelan J, Campo JV. Prioritizing research to reduce youth suicide and suicidal behavior. Am J Prev Med. 2014 Sep;47(3 Suppl 2):S229-34. doi: 10.1016/j.amepre.2014.06.001.
PMID: 25145744
citation: Wyzga RE. The effect of air pollution upon mortality: a consideration of distributed lag models. J Am Stat Assoc. 1978;73(363):463-72. doi: 10.1080/01621459.1978.10480035. No abstract available.
PMID: 12262745
citation: Pisani AR, Cross WF, Watts A, Conner K. Evaluation of the Commitment to Living (CTL) curriculum: a 3-hour training for mental health professionals to address suicide risk. Crisis. 2012 Jan 1;33(1):30-8. doi: 10.1027/0227-5910/a000099.
PMID: 21940243
citation: Aiken LS, West SG. Multiple regression: Testing and interpreting interactions. Newbury Park, CA: Sage; 1991.
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Wendi Cross
investigator title: Associate Professor
mesh term: Suicide
mesh term: Suicide Prevention
sharing ipd: No