<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/NCT02206386</url>
  </required_header>
  <id_info>
    <org_study_id>R01MH096441</org_study_id>
    <secondary_id>R01MH096441</secondary_id>
    <nct_id>NCT02206386</nct_id>
  </id_info>
  <brief_title>Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression</brief_title>
  <official_title>Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To identify effective implementation strategies that can efficiently promote the use of&#xD;
      evidence-based practices (EBP) across a large number of geographically dispersed, independent&#xD;
      Home Health Agencies (HHAs). This study will use an agency-randomized design to test the&#xD;
      effectiveness of a web-based implementation strategy (MHTraining-Net) on the use of an&#xD;
      evidence-based practice for geriatric depression by home healthcare agencies. The EBP is&#xD;
      known as the Depression CARE for PATients at Home (CAREPATH) Intervention. The effectiveness&#xD;
      of MHTraining-Net will be measured by an agency's adherence to the Depression CAREPATH&#xD;
      protocol with its depressed patients and changes in their patients' depressive symptoms over&#xD;
      the episode of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MHTraining-Net uses a web-based platform and several long distance tools (e.g., e-learning&#xD;
      modules, telephone or web consultation, telephone calls, toolkits, and discussion boards) to&#xD;
      deliver four types of implementation activities: infrastructure development, training and&#xD;
      education, quality improvement, and social networking. MHTraining-Net was developed to ensure&#xD;
      that the Depression CAREPATH (CARE for PATients at Home), specifically, and evidence-based&#xD;
      practices, generally, can be implemented widely and successfully across independent&#xD;
      organizations within a sector of care.&#xD;
&#xD;
      PROCEDURES: The effectiveness of MHTraining-Net on the implementation of the Depression&#xD;
      CAREPATH will be tested in an agency-randomized trial of 160 HHAs. All HHAs are clients of&#xD;
      Brightree (formerly CareAnyware, Inc), a software company that offers web-based point-of-care&#xD;
      clinical management and administrative support for HHA nationwide. HHA clinicians record&#xD;
      relevant data that is transmitted directly to Brightree for clinical and administrative&#xD;
      purposes, including quality improvement initiatives. As part of each HHA's contract with&#xD;
      Brightree is permission for using these data for performance enhancement research.&#xD;
&#xD;
      Brightree has already programmed Cornell's Depression CAREPATH, a depression care management&#xD;
      protocol, into its clinical management system so that all nurses use the protocol. To promote&#xD;
      the use of the protocol, Brightree has posted two relevant videos (archived Patient Health&#xD;
      Questionnaire-9 training web seminar training); demonstration of how to navigate the protocol&#xD;
      within the software) on its user education website.&#xD;
&#xD;
      Brightree will randomize HHAs to either MHTraining-Net, (N=100) or to Enhanced Support&#xD;
      (N=60). Enhanced Support will have access to only the two training videos until the end of&#xD;
      the study when they will be invited to MHTraining-Net. These procedures represent Brightree's&#xD;
      typical &quot;roll-out&quot; approach on introducing new training and products to their client HHAs.&#xD;
&#xD;
      The study will test its hypotheses using three sets of data:&#xD;
&#xD;
        1. Summary statistics describing the size and type of the 160 HHAs as well as their average&#xD;
           nurse productivity over the 12 months preceding and following the study;&#xD;
&#xD;
        2. Routinely collected administrative data on patients age &gt;65 who screen positive for&#xD;
           depression over one year, including Medicare-mandated assessments, medication lists,&#xD;
           transaction files, indicators of whether the depression care management protocol was&#xD;
           used, and Medicare case-mix adjustment and reimbursement indicators. We are using to&#xD;
           term 'patients' to refer to a full episode of patient care, defined from the&#xD;
           Start-of-Care date to Discharge, recognizing that a small proportion of unique&#xD;
           individuals may have more than one full episode of care. We will not be able to identify&#xD;
           such individuals. These data will be aggregated at the patient level in preparation for&#xD;
           performance enhancement analyses using Brightree's routine procedures. Brightree will&#xD;
           code the data, remove identifiers, and transmit them to Weill Cornell on a regular basis&#xD;
           using the Weill Cornell ITS Department secure servers and protocols.&#xD;
&#xD;
        3. Agency-level data on the use of the MHTraining-Net website (e.g., summary reports on&#xD;
           'hits' of each webpage) and agency-initiated contacts (telephone, email) through records&#xD;
           maintained by Cornell project staff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nurse adherence to the depression care management protocol (Depression CAREPATH intervention).</measure>
    <time_frame>one episode (60 days)</time_frame>
    <description>At least one follow-up depression assessment and evidence of case coordination (e.g., contacting the patient's physician or a specialist) to evaluate treatment needs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reduction in depression symptoms</measure>
    <time_frame>one episode of care (60 days)</time_frame>
    <description>Patient Health Questionnaire (two item version and nine item version)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">7800</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>MentalHealthTraining-Net</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MHTraining-Net is an implementation strategy that uses a web-based platform with several long distance tools (e.g. e-learning modules, consultation, telephone calls, toolkits, and discussion boards) to deliver four types of implementation activities: infrastructure development, training and education, quality improvement, and social networking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Support</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded trainings in the use of the protocol and depression screening posted by Brightree.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MHTraining-Net</intervention_name>
    <description>See Arm Description for more details.</description>
    <arm_group_label>MentalHealthTraining-Net</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Support</intervention_name>
    <description>Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded training in the use of the protocol and depression screening posted by Brightree.</description>
    <arm_group_label>Enhanced Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Geriatric patients 65 and older&#xD;
&#xD;
          -  Patients screened for depression using the Patient Health Questionnaire-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Geriatric patients under age 65&#xD;
&#xD;
          -  Patients who were not screened for depression using the Patient Health Questionnaire-2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martha L Bruce, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bruce ML, Raue PJ, Sheeran T, Reilly C, Pomerantz JC, Meyers BS, Weinberger MI, Zukowski D. Depression Care for Patients at Home (Depression CAREPATH): home care depression care management protocol, part 2. Home Healthc Nurse. 2011 Sep;29(8):480-9. doi: 10.1097/NHH.0b013e318229d75b.</citation>
    <PMID>21881429</PMID>
  </reference>
  <reference>
    <citation>Bruce ML, Sheeran T, Raue PJ, Reilly CF, Greenberg RL, Pomerantz JC, Meyers BS, Weinberger MI, Johnston CL. Depression care for patients at home (Depression CAREPATH): intervention development and implementation, part 1. Home Healthc Nurse. 2011 Jul-Aug;29(7):416-26. doi: 10.1097/NHH.0b013e31821fe9f7.</citation>
    <PMID>21716043</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT02206386
org study id: R01MH096441
secondary id: R01MH096441
nct id: NCT02206386
lead sponsor: 
collaborator: 
has dmc: No
To identify effective implementation strategies that can efficiently promote the use of
      evidence-based practices (EBP) across a large number of geographically dispersed, independent
      Home Health Agencies (HHAs). This study will use an agency-randomized design to test the
      effectiveness of a web-based implementation strategy (MHTraining-Net) on the use of an
      evidence-based practice for geriatric depression by home healthcare agencies. The EBP is
      known as the Depression CARE for PATients at Home (CAREPATH) Intervention. The effectiveness
      of MHTraining-Net will be measured by an agency's adherence to the Depression CAREPATH
      protocol with its depressed patients and changes in their patients' depressive symptoms over
      the episode of care.
MHTraining-Net uses a web-based platform and several long distance tools (e.g., e-learning
      modules, telephone or web consultation, telephone calls, toolkits, and discussion boards) to
      deliver four types of implementation activities: infrastructure development, training and
      education, quality improvement, and social networking. MHTraining-Net was developed to ensure
      that the Depression CAREPATH (CARE for PATients at Home), specifically, and evidence-based
      practices, generally, can be implemented widely and successfully across independent
      organizations within a sector of care.

      PROCEDURES: The effectiveness of MHTraining-Net on the implementation of the Depression
      CAREPATH will be tested in an agency-randomized trial of 160 HHAs. All HHAs are clients of
      Brightree (formerly CareAnyware, Inc), a software company that offers web-based point-of-care
      clinical management and administrative support for HHA nationwide. HHA clinicians record
      relevant data that is transmitted directly to Brightree for clinical and administrative
      purposes, including quality improvement initiatives. As part of each HHA's contract with
      Brightree is permission for using these data for performance enhancement research.

      Brightree has already programmed Cornell's Depression CAREPATH, a depression care management
      protocol, into its clinical management system so that all nurses use the protocol. To promote
      the use of the protocol, Brightree has posted two relevant videos (archived Patient Health
      Questionnaire-9 training web seminar training); demonstration of how to navigate the protocol
      within the software) on its user education website.

      Brightree will randomize HHAs to either MHTraining-Net, (N=100) or to Enhanced Support
      (N=60). Enhanced Support will have access to only the two training videos until the end of
      the study when they will be invited to MHTraining-Net. These procedures represent Brightree's
      typical "roll-out" approach on introducing new training and products to their client HHAs.

      The study will test its hypotheses using three sets of data:

        1. Summary statistics describing the size and type of the 160 HHAs as well as their average
           nurse productivity over the 12 months preceding and following the study;

        2. Routinely collected administrative data on patients age >65 who screen positive for
           depression over one year, including Medicare-mandated assessments, medication lists,
           transaction files, indicators of whether the depression care management protocol was
           used, and Medicare case-mix adjustment and reimbursement indicators. We are using to
           term 'patients' to refer to a full episode of patient care, defined from the
           Start-of-Care date to Discharge, recognizing that a small proportion of unique
           individuals may have more than one full episode of care. We will not be able to identify
           such individuals. These data will be aggregated at the patient level in preparation for
           performance enhancement analyses using Brightree's routine procedures. Brightree will
           code the data, remove identifiers, and transmit them to Weill Cornell on a regular basis
           using the Weill Cornell ITS Department secure servers and protocols.

        3. Agency-level data on the use of the MHTraining-Net website (e.g., summary reports on
           'hits' of each webpage) and agency-initiated contacts (telephone, email) through records
           maintained by Cornell project staff.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Nurse adherence to the depression care management protocol (Depression CAREPATH intervention).
time frame: one episode (60 days)
description: At least one follow-up depression assessment and evidence of case coordination (e.g., contacting the patient's physician or a specialist) to evaluate treatment needs.
measure: Patient reduction in depression symptoms
time frame: one episode of care (60 days)
description: Patient Health Questionnaire (two item version and nine item version)
arm group label: MentalHealthTraining-Net
arm group type: Experimental
description: MHTraining-Net is an implementation strategy that uses a web-based platform with several long distance tools (e.g. e-learning modules, consultation, telephone calls, toolkits, and discussion boards) to deliver four types of implementation activities: infrastructure development, training and education, quality improvement, and social networking.
arm group label: Enhanced Support
arm group type: Active Comparator
description: Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded trainings in the use of the protocol and depression screening posted by Brightree.
intervention type: Other
intervention name: MHTraining-Net
description: See Arm Description for more details.
arm group label: MentalHealthTraining-Net
intervention type: Other
intervention name: Enhanced Support
description: Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded training in the use of the protocol and depression screening posted by Brightree.
arm group label: Enhanced Support
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Martha L Bruce, PhD, MPH
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
citation: Bruce ML, Raue PJ, Sheeran T, Reilly C, Pomerantz JC, Meyers BS, Weinberger MI, Zukowski D. Depression Care for Patients at Home (Depression CAREPATH): home care depression care management protocol, part 2. Home Healthc Nurse. 2011 Sep;29(8):480-9. doi: 10.1097/NHH.0b013e318229d75b.
PMID: 21881429
citation: Bruce ML, Sheeran T, Raue PJ, Reilly CF, Greenberg RL, Pomerantz JC, Meyers BS, Weinberger MI, Johnston CL. Depression care for patients at home (Depression CAREPATH): intervention development and implementation, part 1. Home Healthc Nurse. 2011 Jul-Aug;29(7):416-26. doi: 10.1097/NHH.0b013e31821fe9f7.
PMID: 21716043
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder