<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/NCT02260778</url>
  </required_header>
  <id_info>
    <org_study_id>2012P000664</org_study_id>
    <secondary_id>P60AR047782</secondary_id>
    <nct_id>NCT02260778</nct_id>
  </id_info>
  <brief_title>Treat-to-target in RA: Collaboration To Improve adOption and adhereNce</brief_title>
  <acronym>TRACTION</acronym>
  <official_title>Treat-to-target in RA: Collaboration To Improve adOption and adhereNce (TRACTION)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if a Learning Collaborative is an effective tool to&#xD;
      improve adoption and adherence to a Treat-to-Target (TTT) treatment strategy in U.S.&#xD;
      rheumatology practices for the treatment of Rheumatoid Arthritis (RA). The TTT strategy has&#xD;
      been embraced by the American College of Rheumatology through the RA Treatment Guidelines and&#xD;
      by EULAR,however several lines of evidence suggest that TTT is not practiced consistently&#xD;
      across rheumatology settings.Participating practices will be randomized to receive the&#xD;
      Learning Collaborative intervention in one of two phases. Coaching consistent with Learning&#xD;
      Collaborative practices will be used to promote adherence to TTT. Chart abstraction will be&#xD;
      used to determine if the Learning Collaborative was an effective tool to increase TTT&#xD;
      adherence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twelve rheumatology practices around the U.S. will be recruited to participate in a Learning&#xD;
      Collaborative (LC). Eligible practices will have at least 50 rheumatoid arthritis patients,&#xD;
      at least 2 rheumatologists, and an electronic medical record or typed notes. Each practice&#xD;
      will be randomized to receive the intervention in either phase 1 (first 9 months) or phase 2&#xD;
      (second 9 months).&#xD;
&#xD;
      The collaborative will consist of a series of 9 Learning Sessions (1 conducted face-to-face,&#xD;
      the remaining conducted via webinar) as well as regular coaching sessions and collaborative&#xD;
      sessions. The structure of the collaborative will be such that each learning session will&#xD;
      focus on resources, expertise, and best practices that address common barriers to&#xD;
      Treat-to-Target (TTT) adoption. The follow-up coaching and collaborative sessions will give&#xD;
      providers the opportunity to reflect on what they have learned from their own practices and&#xD;
      from each other.&#xD;
&#xD;
      The first Learning Session was a one-day face-to-face meeting that consisted of orienting the&#xD;
      teams to the Model for Improvement, describing the Change Package and its content, conducting&#xD;
      team building activities focused on developing ideas for plan-do-study-act (PDSA) cycles, and&#xD;
      cross-team learning activities. (The PDSA cycles refer to tests of change, using four stages,&#xD;
      that are performed as part of a quality improvement process.) The day primarily consisted of&#xD;
      discussion sessions, and several lectures on TTT, disease activity measures, and shared&#xD;
      decision making helped orient teams to the Change Package contents. There was ample time for&#xD;
      teams to get feedback from expert faculty on their proposed tests of change and results to&#xD;
      date. Subsequent Learning Sessions were conducted via webinar.&#xD;
&#xD;
      We developed a web-based collaborative tool for the Learning Collaborative. It helped manage&#xD;
      contents being shared across teams (i.e., key resources, PDSAs), displayed monthly&#xD;
      improvement metrics, and provided a discussion board with conversation &quot;threads.&quot; The tool&#xD;
      was used in all Learning Sessions.&#xD;
&#xD;
      Specific patient data will never be identified in the sessions of the Collaborative, and no&#xD;
      specific patient data will be shared between the participating providers. Providers will be&#xD;
      able to interact with each other to share general practice patterns and behaviors, but&#xD;
      sensitive patient information will not be shared.&#xD;
&#xD;
      The intervention will be conducted in 2 phases. In phase 1, a group of 5practices [Cohort 1]&#xD;
      will initiate the collaborative, which will last 9 months. After 9 months, phase 2 will begin&#xD;
      with the remaining practices [Cohort 2] initiating the second collaborative of the same&#xD;
      content as cohort 1, and the second collaborative will also take 9 months to complete. The&#xD;
      cohort 1 and cohort 2 collaborative groups will not have any interaction with each other, but&#xD;
      cohort 2 will serve as a concurrent control to cohort 1 in the first 9 months of the&#xD;
      intervention.&#xD;
&#xD;
      De-identified data will be collected from participating sites to compare TTT practices prior&#xD;
      to and following the Learning Collaborative intervention using a chart review abstraction&#xD;
      tool. The tool has four items: 1) documentation of a treatment target; 2) documentation of&#xD;
      shared decision making; 3) documentation of a disease activity measure; and 4) evidence that&#xD;
      this information guided treatment decisions. This tool will be used to grade the visit in the&#xD;
      two months immediately prior to the start of Phase 1 and the visit in the two months&#xD;
      immediately prior to the end of Phase 1; a change score between baseline to follow-up will be&#xD;
      calculated. The range of change in implementation of TTT can vary from -4 (worsening from 4&#xD;
      at baseline to 0 at follow-up) to +4 (improvement from 0 at baseline to 4 at follow-up).&#xD;
      Thus, the range of change scores will be from -4 to +4, a 9-point ordinal scale. The baseline&#xD;
      visit will be considered the patient visit within two months before the start of Phase 1&#xD;
      (January 2015). If there are multiple visits in this time-frame, then the note for the visit&#xD;
      most proximal to January 2015 (start of the study) will be assessed. The end of Phase 1 visit&#xD;
      will be considered the visit within two months before November 1, 2015. Again, if there are&#xD;
      multiple visits in this time-frame, then the note for the visit most proximal to October 1,&#xD;
      2015 will be assessed. When assessing the performance at each site, we will randomly sample&#xD;
      the medical records of patients with RA who have visits documented within these two&#xD;
      time-frames.&#xD;
&#xD;
      Surveys will also be collected from patients and providers to assess satisfaction with the&#xD;
      patient-provider interaction and shared decision-making. RA patients were randomly selected&#xD;
      at each site to complete a questionnaire rating their satisfaction with the shared&#xD;
      decision-making process using the three item collaboRATE scale. This was carried out at the&#xD;
      start of Phase I and will be re-assessed at the end of Phase 1. Similarly, we asked providers&#xD;
      involved in the Learning Collaborative from all sites in both groups to complete a modified&#xD;
      version of this questionnaire; this will also be re-assessed at the end of Phase 1. During&#xD;
      Phase 2, the only outcomes we plan to assess are the primary outcome of TTT implementation as&#xD;
      well as the patient collaboRATE scale.&#xD;
&#xD;
      The primary analysis will compare the primary outcome among the Learning Collaborative sites&#xD;
      with the control sites. The mean change in implementation of TTT for the Learning&#xD;
      Collaborative arm will be compared with implementation of TTT for the control arm after&#xD;
      accounting for intra-cluster correlation using linear mixed models. Although the normality&#xD;
      assumption may be violated when the outcome variable is ordinal, linear mixed models should&#xD;
      still be valid for the proposed sample size. Treatment arm will be the exposure of interest.&#xD;
      Covariates included in the model will include provider-level characteristics (such as age,&#xD;
      gender, training), patient-level characteristics (age, gender, baseline disease activity,&#xD;
      baseline RA drugs), and other covariates found to be unbalanced at baseline. While these&#xD;
      characteristics should be balanced given the random assignment to treatment arm, the small&#xD;
      number of centers in each arm opens the possibility of baseline differences and thus the&#xD;
      rationale for adjustment. Similarly, for the secondary outcomes (dichotomous variables), we&#xD;
      will use generalized linear mixed models for binary outcomes.&#xD;
&#xD;
      The trial has been powered based on the primary outcome - the estimated difference in change&#xD;
      in TTT implementation between the Learning Collaborative intervention and the control sites.&#xD;
      Several other assumptions underpin the sample size estimation. First, the control group would&#xD;
      have no or only small change (0-5%) change in implementation of TTT compared with a change in&#xD;
      the intervention group of 20-40%, an improvement level observed in a similar prior trial&#xD;
      using a Learning Collaborative. Second, we will include 5 sites in the intervention group,&#xD;
      and 6 in the control group. We assume that average number of providers in each practice is 5,&#xD;
      and expect there would be substantial intra-cluster correlation (ICC) among patients within a&#xD;
      given provider. We conservatively assume a range of ICC is 0.1-0.3 based on prior work.&#xD;
      Third, the significant level (alpha) would be two-sided 0.05, and the goal power would be&#xD;
      80%.&#xD;
&#xD;
      Based on these assumptions, we estimated sample sizes for the proposed trial. The required&#xD;
      number of patients per provider needed to detected meaningful differences was calculated for&#xD;
      each set of assumptions. Based on these estimates, we will review a random 6 patients per&#xD;
      provider with eligible visits to ensure an adequate sample size to achieve 80% power.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of adherence to TTT by provider</measure>
    <time_frame>9 months</time_frame>
    <description>Chart abstraction will determine how strongly providers adhered to treat-to-target principles before and following the Learning Collaborative.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient disease activity and adverse events</measure>
    <time_frame>9 months</time_frame>
    <description>Chart abstraction will determine how TTT adherence correlates with patient disease activity and adverse events before and following the Learning Collaborative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient/provider satisfaction</measure>
    <time_frame>within 1 month following intervention</time_frame>
    <description>Surveys will determine how the TTT principle of shared decision making affects satisfaction with the patient and provider experiences before and following the Learning Collaborative.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Resource Utilization</measure>
    <time_frame>9 months</time_frame>
    <description>Chart abstraction will determine if a directional relationship exists between adherence to TTT and resource utilization (frequency of medications, labs, clinical exams, etc.) before and following the Learning Collaborative.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>Phase I Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The learning collaborative as designed will be delivered to this arm during phase I, which will last a period of approximately 9 months. After the 9 months, there will be passive follow-up of this arm to see if outcomes following the first 9 months are sustained.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase II Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm will serve as a control for the Phase I intervention arm during the first 9 months of the study for primary analysis. After the first 9 months, the Phase II intervention arm will receive the learning collaborative during the following 9 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Learning Collaborative</intervention_name>
    <description>A learning collaborative is an established technique that uses the model for improvement to bridge the gap between what we know and what we do. Structured learning sessions and collaborative coaching are used to guide small cycles of change called Plan-Do-Study-Act (PDSA) cycles. This quality improvement intervention will help providers adopt treat-to-target practices through the structured learning collaborative.</description>
    <arm_group_label>Phase I Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  rheumatology practices with at least 50 RA patients for the practice&#xD;
&#xD;
          -  rheumatology practices with at least 2 rheumatologists&#xD;
&#xD;
          -  rheumatology practices utilizing an electronic medical record or typed notes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  rheumatology practices already explicitly employing Treat-to-target principles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel H Solomon, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
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  <verification_date>February 2023</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Daniel H. Solomon, M.D.,MPH</investigator_full_name>
    <investigator_title>Chief, Section of Clinical Sciences</investigator_title>
  </responsible_party>
  <keyword>Learning Collaborative</keyword>
  <keyword>Treat-to-Target</keyword>
  <keyword>Arthritis, Rheumatoid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT02260778
org study id: 2012P000664
secondary id: P60AR047782
nct id: NCT02260778
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine if a Learning Collaborative is an effective tool to
      improve adoption and adherence to a Treat-to-Target (TTT) treatment strategy in U.S.
      rheumatology practices for the treatment of Rheumatoid Arthritis (RA). The TTT strategy has
      been embraced by the American College of Rheumatology through the RA Treatment Guidelines and
      by EULAR,however several lines of evidence suggest that TTT is not practiced consistently
      across rheumatology settings.Participating practices will be randomized to receive the
      Learning Collaborative intervention in one of two phases. Coaching consistent with Learning
      Collaborative practices will be used to promote adherence to TTT. Chart abstraction will be
      used to determine if the Learning Collaborative was an effective tool to increase TTT
      adherence.
Twelve rheumatology practices around the U.S. will be recruited to participate in a Learning
      Collaborative (LC). Eligible practices will have at least 50 rheumatoid arthritis patients,
      at least 2 rheumatologists, and an electronic medical record or typed notes. Each practice
      will be randomized to receive the intervention in either phase 1 (first 9 months) or phase 2
      (second 9 months).

      The collaborative will consist of a series of 9 Learning Sessions (1 conducted face-to-face,
      the remaining conducted via webinar) as well as regular coaching sessions and collaborative
      sessions. The structure of the collaborative will be such that each learning session will
      focus on resources, expertise, and best practices that address common barriers to
      Treat-to-Target (TTT) adoption. The follow-up coaching and collaborative sessions will give
      providers the opportunity to reflect on what they have learned from their own practices and
      from each other.

      The first Learning Session was a one-day face-to-face meeting that consisted of orienting the
      teams to the Model for Improvement, describing the Change Package and its content, conducting
      team building activities focused on developing ideas for plan-do-study-act (PDSA) cycles, and
      cross-team learning activities. (The PDSA cycles refer to tests of change, using four stages,
      that are performed as part of a quality improvement process.) The day primarily consisted of
      discussion sessions, and several lectures on TTT, disease activity measures, and shared
      decision making helped orient teams to the Change Package contents. There was ample time for
      teams to get feedback from expert faculty on their proposed tests of change and results to
      date. Subsequent Learning Sessions were conducted via webinar.

      We developed a web-based collaborative tool for the Learning Collaborative. It helped manage
      contents being shared across teams (i.e., key resources, PDSAs), displayed monthly
      improvement metrics, and provided a discussion board with conversation "threads." The tool
      was used in all Learning Sessions.

      Specific patient data will never be identified in the sessions of the Collaborative, and no
      specific patient data will be shared between the participating providers. Providers will be
      able to interact with each other to share general practice patterns and behaviors, but
      sensitive patient information will not be shared.

      The intervention will be conducted in 2 phases. In phase 1, a group of 5practices [Cohort 1]
      will initiate the collaborative, which will last 9 months. After 9 months, phase 2 will begin
      with the remaining practices [Cohort 2] initiating the second collaborative of the same
      content as cohort 1, and the second collaborative will also take 9 months to complete. The
      cohort 1 and cohort 2 collaborative groups will not have any interaction with each other, but
      cohort 2 will serve as a concurrent control to cohort 1 in the first 9 months of the
      intervention.

      De-identified data will be collected from participating sites to compare TTT practices prior
      to and following the Learning Collaborative intervention using a chart review abstraction
      tool. The tool has four items: 1) documentation of a treatment target; 2) documentation of
      shared decision making; 3) documentation of a disease activity measure; and 4) evidence that
      this information guided treatment decisions. This tool will be used to grade the visit in the
      two months immediately prior to the start of Phase 1 and the visit in the two months
      immediately prior to the end of Phase 1; a change score between baseline to follow-up will be
      calculated. The range of change in implementation of TTT can vary from -4 (worsening from 4
      at baseline to 0 at follow-up) to +4 (improvement from 0 at baseline to 4 at follow-up).
      Thus, the range of change scores will be from -4 to +4, a 9-point ordinal scale. The baseline
      visit will be considered the patient visit within two months before the start of Phase 1
      (January 2015). If there are multiple visits in this time-frame, then the note for the visit
      most proximal to January 2015 (start of the study) will be assessed. The end of Phase 1 visit
      will be considered the visit within two months before November 1, 2015. Again, if there are
      multiple visits in this time-frame, then the note for the visit most proximal to October 1,
      2015 will be assessed. When assessing the performance at each site, we will randomly sample
      the medical records of patients with RA who have visits documented within these two
      time-frames.

      Surveys will also be collected from patients and providers to assess satisfaction with the
      patient-provider interaction and shared decision-making. RA patients were randomly selected
      at each site to complete a questionnaire rating their satisfaction with the shared
      decision-making process using the three item collaboRATE scale. This was carried out at the
      start of Phase I and will be re-assessed at the end of Phase 1. Similarly, we asked providers
      involved in the Learning Collaborative from all sites in both groups to complete a modified
      version of this questionnaire; this will also be re-assessed at the end of Phase 1. During
      Phase 2, the only outcomes we plan to assess are the primary outcome of TTT implementation as
      well as the patient collaboRATE scale.

      The primary analysis will compare the primary outcome among the Learning Collaborative sites
      with the control sites. The mean change in implementation of TTT for the Learning
      Collaborative arm will be compared with implementation of TTT for the control arm after
      accounting for intra-cluster correlation using linear mixed models. Although the normality
      assumption may be violated when the outcome variable is ordinal, linear mixed models should
      still be valid for the proposed sample size. Treatment arm will be the exposure of interest.
      Covariates included in the model will include provider-level characteristics (such as age,
      gender, training), patient-level characteristics (age, gender, baseline disease activity,
      baseline RA drugs), and other covariates found to be unbalanced at baseline. While these
      characteristics should be balanced given the random assignment to treatment arm, the small
      number of centers in each arm opens the possibility of baseline differences and thus the
      rationale for adjustment. Similarly, for the secondary outcomes (dichotomous variables), we
      will use generalized linear mixed models for binary outcomes.

      The trial has been powered based on the primary outcome - the estimated difference in change
      in TTT implementation between the Learning Collaborative intervention and the control sites.
      Several other assumptions underpin the sample size estimation. First, the control group would
      have no or only small change (0-5%) change in implementation of TTT compared with a change in
      the intervention group of 20-40%, an improvement level observed in a similar prior trial
      using a Learning Collaborative. Second, we will include 5 sites in the intervention group,
      and 6 in the control group. We assume that average number of providers in each practice is 5,
      and expect there would be substantial intra-cluster correlation (ICC) among patients within a
      given provider. We conservatively assume a range of ICC is 0.1-0.3 based on prior work.
      Third, the significant level (alpha) would be two-sided 0.05, and the goal power would be
      80%.

      Based on these assumptions, we estimated sample sizes for the proposed trial. The required
      number of patients per provider needed to detected meaningful differences was calculated for
      each set of assumptions. Based on these estimates, we will review a random 6 patients per
      provider with eligible visits to ensure an adequate sample size to achieve 80% power.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Evidence of adherence to TTT by provider
time frame: 9 months
description: Chart abstraction will determine how strongly providers adhered to treat-to-target principles before and following the Learning Collaborative.
measure: Patient disease activity and adverse events
time frame: 9 months
description: Chart abstraction will determine how TTT adherence correlates with patient disease activity and adverse events before and following the Learning Collaborative.
measure: Patient/provider satisfaction
time frame: within 1 month following intervention
description: Surveys will determine how the TTT principle of shared decision making affects satisfaction with the patient and provider experiences before and following the Learning Collaborative.
measure: Resource Utilization
time frame: 9 months
description: Chart abstraction will determine if a directional relationship exists between adherence to TTT and resource utilization (frequency of medications, labs, clinical exams, etc.) before and following the Learning Collaborative.
arm group label: Phase I Intervention
arm group type: Experimental
description: The learning collaborative as designed will be delivered to this arm during phase I, which will last a period of approximately 9 months. After the 9 months, there will be passive follow-up of this arm to see if outcomes following the first 9 months are sustained.
arm group label: Phase II Intervention
arm group type: No Intervention
description: This arm will serve as a control for the Phase I intervention arm during the first 9 months of the study for primary analysis. After the first 9 months, the Phase II intervention arm will receive the learning collaborative during the following 9 months.
intervention type: Behavioral
intervention name: Learning Collaborative
description: A learning collaborative is an established technique that uses the model for improvement to bridge the gap between what we know and what we do. Structured learning sessions and collaborative coaching are used to guide small cycles of change called Plan-Do-Study-Act (PDSA) cycles. This quality improvement intervention will help providers adopt treat-to-target practices through the structured learning collaborative.
arm group label: Phase I Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel H Solomon, MD MPH
role: Principal Investigator
affiliation: Brigham and Women's Hospital
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responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Daniel H. Solomon, M.D.,MPH
investigator title: Chief, Section of Clinical Sciences
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid