<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/NCT02247050</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00087820</org_study_id>
    <secondary_id>71475</secondary_id>
    <nct_id>NCT02247050</nct_id>
  </id_info>
  <brief_title>Primary Care Clinician Commitments to Choosing Wisely®</brief_title>
  <official_title>Primary Care Clinician Commitments to Choosing Wisely®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Robert Wood Johnson Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IHA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pragmatic trial examines the uptake and effects of primary care clinician commitments to&#xD;
      follow 3 Choosing Wisely® recommendations. The investigators hypothesize that pre-encounter&#xD;
      invitations to clinicians to commit to the recommendations will decrease ordering of: (1)&#xD;
      imaging tests for low back pain, (2) antibiotics for acute sinusitis, and (3) imaging tests&#xD;
      for headaches. The study is a mixed-methods, stepped wedge cluster randomized trial in which&#xD;
      the intervention will be sequentially introduced to 6 clinics in southeastern Michigan in a&#xD;
      randomly assigned order.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinicians often make decisions about ordering low-value services in the midst of clinical&#xD;
      encounters when their thinking can be rushed and susceptible to patient demands. This&#xD;
      pragmatic trial examines the uptake and effects of shifting clinicians' decisions about&#xD;
      ordering low-value services to the pre-encounter period when their thinking is slower and&#xD;
      more deliberative; inviting clinicians to commit to avoid ordering those services during&#xD;
      patient encounters; and providing to clinicians who committed decision support resources such&#xD;
      as point-of-care reminders, patient education handouts, and access to brief communications&#xD;
      training.&#xD;
&#xD;
      The investigators will conduct a mixed-methods, stepped wedge cluster randomized trial in 6&#xD;
      IHA primary care clinics in southeastern Michigan. The intervention will be introduced in&#xD;
      each clinic in sequence approximately one month apart and in a randomly assigned order (i.e.,&#xD;
      temporal randomization). In each clinic the intervention will continue for 1 to 6 months so&#xD;
      that the intervention ends in all clinics at the same time. For example, in the first clinic&#xD;
      the intervention will run for 6 months; in the sixth clinic the intervention will run for 1&#xD;
      month. The total length of the control period plus the intervention period will be 8 months&#xD;
      at all clinics.&#xD;
&#xD;
      Prior to the start of the study, IHA made its primary care clinicians aware of publicly&#xD;
      available recommendations from the ABIM Foundation's Choosing Wisely® campaign applicable to&#xD;
      avoiding overuse of low-value services for 3 common conditions: (1) low back pain, (2) acute&#xD;
      sinusitis, and (3) headaches. However, research has shown that clinician behavior seldom&#xD;
      changes as a result of information alone. Therefore, at the start of the intervention period&#xD;
      clinicians will be invited to make a pre-encounter commitment to follow the 3 Choosing Wisely&#xD;
      recommendations. Clinicians who choose to commit will throughout the intervention period&#xD;
      receive point-of-care commitment reminders, Choosing Wisely patient education handouts, and&#xD;
      weekly emails with decision support resources. Clinicians will remain free to order services&#xD;
      at any time without penalty.&#xD;
&#xD;
      The investigators will measure whether the clinician-focused intervention leads to declines&#xD;
      in rates of ordering imaging tests for low back pain, antibiotics for acute sinusitis, and&#xD;
      imaging tests for headaches. The study team will analyze ordering patterns and costs using&#xD;
      clinical operations datasets (drawn from electronic health records and from the billing and&#xD;
      practice management system). The following hypotheses will be tested:&#xD;
&#xD;
      Hypothesis 1: Inviting primary care clinicians to commit to avoid ordering imaging for low&#xD;
      back pain, antibiotics for acute sinusitis, and imaging for headaches will decrease ordering&#xD;
      of these services.&#xD;
&#xD;
      Hypothesis 2: Inviting primary care clinicians to commit to avoid ordering imaging for low&#xD;
      back pain, antibiotics for acute sinusitis, and imaging for headaches will reduce health care&#xD;
      costs in patient visits for low back pain, acute sinusitis, and headaches.&#xD;
&#xD;
      Hypothesis 3: Inviting primary care clinicians to commit to avoid ordering low-value services&#xD;
      will reduce per-clinician per-visit health care costs across clinical conditions.&#xD;
&#xD;
      For each outcome investigators will also compare differences between clinicians who did and&#xD;
      did not commit to follow the 3 Choosing Wisely recommendations. Additionally, investigators&#xD;
      will compare differences in outcomes between the 3-month follow-up period (immediately after&#xD;
      the intervention has ended) and the control and intervention periods.&#xD;
&#xD;
      After the intervention period, the study team will conduct surveys and semi-structured&#xD;
      interviews with study clinicians. The survey results will be used to identify correlates of&#xD;
      primary care clinician uptake of invitations to commit to avoid ordering low-value services.&#xD;
      The semi-structured interviews will elicit qualitative data on clinician attitudes towards&#xD;
      overuse of low-value services, clinicians' responses to the intervention, and facilitators of&#xD;
      and barriers to avoidance of delivering low-value care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite rates of ordering 3 potentially low-value services in primary care visits by adult patients</measure>
    <time_frame>Within 10 months of receiving the intervention</time_frame>
    <description>Composite rates of ordering lumbar spine imaging tests in visits for low back pain, ordering antibiotics in visits for acute sinusitis, and ordering head imaging tests in visits for headaches.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite rates of ordering potential substitute services for 3 potentially low-value services in primary care visits by adult patients</measure>
    <time_frame>Within 10 months of receiving the intervention</time_frame>
    <description>Composite rates of ordering potential substitute services for lumbar spine imaging tests in visits for low back pain, ordering antibiotics in visits for acute sinusitis, and ordering head imaging tests in visits for headaches.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Health Services Misuse</condition>
  <condition>Physician's Practice Patterns</condition>
  <condition>Guideline Adherence</condition>
  <condition>Unnecessary Procedures</condition>
  <condition>Health Care Costs</condition>
  <arm_group>
    <arm_group_label>Commitment invitation at time 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Behavioral: Commitment Invitation&#xD;
In the stepped wedge cluster randomized design, the first clinic will remain in the control period (no intervention) for 2 months and then cross over to the intervention period for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commitment invitation at time 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Behavioral: Commitment Invitation&#xD;
In the stepped wedge cluster randomized design, the second clinic will remain in the control period (no intervention) for 3 months and then cross over to the intervention period for 5 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commitment invitation at time 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Behavioral: Commitment Invitation&#xD;
In the stepped wedge cluster randomized design, the third clinic will remain in the control period (no intervention) for 4 months and then cross over to the intervention period for 4 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commitment invitation at time 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Behavioral: Commitment Invitation&#xD;
In the stepped wedge cluster randomized design, the fourth clinic will remain in the control period (no intervention) for 5 months and then cross over to the intervention period for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commitment invitation at time 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Behavioral: Commitment Invitation&#xD;
In the stepped wedge cluster randomized design, the fifth clinic will remain in the control period (no intervention) for 6 months and then cross over to the intervention period for 2 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commitment invitation at time 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Behavioral: Commitment Invitation&#xD;
In the stepped wedge cluster randomized design, the sixth clinic will remain in the control period (no intervention) for 7 months and then cross over to the intervention period for 1 month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Commitment invitation</intervention_name>
    <description>Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.</description>
    <arm_group_label>Commitment invitation at time 1</arm_group_label>
    <arm_group_label>Commitment invitation at time 2</arm_group_label>
    <arm_group_label>Commitment invitation at time 3</arm_group_label>
    <arm_group_label>Commitment invitation at time 4</arm_group_label>
    <arm_group_label>Commitment invitation at time 5</arm_group_label>
    <arm_group_label>Commitment invitation at time 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary care clinicians in 6 primary care (family medicine and internal medicine)&#xD;
             clinics within the IHA organization of Ann Arbor, Michigan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey T. Kullgren, MD, MS, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IHA Ann Arbor Family Medicine</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Family Medicine - Arbor Park</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Internal Medicine - Domino's Farms</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Brighton Family Care</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Internal Medicine - Cherry Hill</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48187</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Reichert Internal Medicine at Towsley</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>May 5, 2016</last_update_submitted>
  <last_update_submitted_qc>May 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Jeffrey T. Kullgren</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Costs and Cost Analysis</keyword>
  <keyword>Professional Practice</keyword>
  <keyword>Attitude of Health Personnel</keyword>
  <keyword>Health Knowledge, Attitudes, and Practice</keyword>
  <keyword>Decision Making</keyword>
  <keyword>Practice Guidelines as Topic</keyword>
  <keyword>Physician-Patient Relations</keyword>
  <keyword>Physician's Role</keyword>
  <keyword>Health Care</keyword>
  <keyword>Quality of Health Care</keyword>
  <keyword>Quality Assurance</keyword>
  <keyword>Physicians, Primary Care</keyword>
  <keyword>Evidence-Based Medicine</keyword>
  <keyword>Evidence-Based Practice</keyword>
  <keyword>Decision Support Systems, Clinical</keyword>
  <keyword>Reminder Systems</keyword>
  <keyword>Judgment</keyword>
  <keyword>Cognition</keyword>
  <keyword>Patient Care</keyword>
  <keyword>Health Services Misuse</keyword>
  <keyword>Unnecessary Procedures</keyword>
  <keyword>Prescribing Patterns, Physician</keyword>
  <keyword>Inappropriate Prescribing</keyword>
  <keyword>Over Prescribing</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Sinusitis</keyword>
  <keyword>Infections, Upper Respiratory</keyword>
  <keyword>Generalized Headache</keyword>
  <keyword>Imaging, Diagnostic</keyword>
  <keyword>Antibiotics</keyword>
  <keyword>Humans</keyword>
  <keyword>Overuse of Low-Value Services</keyword>
  <keyword>Pragmatic Trial</keyword>
  <keyword>Stepped Wedge Design</keyword>
  <keyword>Cluster Randomized Trial</keyword>
  <keyword>Choosing Wisely</keyword>
  <!-- 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/NCT02247050
org study id: HUM00087820
secondary id: 71475
nct id: NCT02247050
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This pragmatic trial examines the uptake and effects of primary care clinician commitments to
      follow 3 Choosing Wisely® recommendations. The investigators hypothesize that pre-encounter
      invitations to clinicians to commit to the recommendations will decrease ordering of: (1)
      imaging tests for low back pain, (2) antibiotics for acute sinusitis, and (3) imaging tests
      for headaches. The study is a mixed-methods, stepped wedge cluster randomized trial in which
      the intervention will be sequentially introduced to 6 clinics in southeastern Michigan in a
      randomly assigned order.
Clinicians often make decisions about ordering low-value services in the midst of clinical
      encounters when their thinking can be rushed and susceptible to patient demands. This
      pragmatic trial examines the uptake and effects of shifting clinicians' decisions about
      ordering low-value services to the pre-encounter period when their thinking is slower and
      more deliberative; inviting clinicians to commit to avoid ordering those services during
      patient encounters; and providing to clinicians who committed decision support resources such
      as point-of-care reminders, patient education handouts, and access to brief communications
      training.

      The investigators will conduct a mixed-methods, stepped wedge cluster randomized trial in 6
      IHA primary care clinics in southeastern Michigan. The intervention will be introduced in
      each clinic in sequence approximately one month apart and in a randomly assigned order (i.e.,
      temporal randomization). In each clinic the intervention will continue for 1 to 6 months so
      that the intervention ends in all clinics at the same time. For example, in the first clinic
      the intervention will run for 6 months; in the sixth clinic the intervention will run for 1
      month. The total length of the control period plus the intervention period will be 8 months
      at all clinics.

      Prior to the start of the study, IHA made its primary care clinicians aware of publicly
      available recommendations from the ABIM Foundation's Choosing Wisely® campaign applicable to
      avoiding overuse of low-value services for 3 common conditions: (1) low back pain, (2) acute
      sinusitis, and (3) headaches. However, research has shown that clinician behavior seldom
      changes as a result of information alone. Therefore, at the start of the intervention period
      clinicians will be invited to make a pre-encounter commitment to follow the 3 Choosing Wisely
      recommendations. Clinicians who choose to commit will throughout the intervention period
      receive point-of-care commitment reminders, Choosing Wisely patient education handouts, and
      weekly emails with decision support resources. Clinicians will remain free to order services
      at any time without penalty.

      The investigators will measure whether the clinician-focused intervention leads to declines
      in rates of ordering imaging tests for low back pain, antibiotics for acute sinusitis, and
      imaging tests for headaches. The study team will analyze ordering patterns and costs using
      clinical operations datasets (drawn from electronic health records and from the billing and
      practice management system). The following hypotheses will be tested:

      Hypothesis 1: Inviting primary care clinicians to commit to avoid ordering imaging for low
      back pain, antibiotics for acute sinusitis, and imaging for headaches will decrease ordering
      of these services.

      Hypothesis 2: Inviting primary care clinicians to commit to avoid ordering imaging for low
      back pain, antibiotics for acute sinusitis, and imaging for headaches will reduce health care
      costs in patient visits for low back pain, acute sinusitis, and headaches.

      Hypothesis 3: Inviting primary care clinicians to commit to avoid ordering low-value services
      will reduce per-clinician per-visit health care costs across clinical conditions.

      For each outcome investigators will also compare differences between clinicians who did and
      did not commit to follow the 3 Choosing Wisely recommendations. Additionally, investigators
      will compare differences in outcomes between the 3-month follow-up period (immediately after
      the intervention has ended) and the control and intervention periods.

      After the intervention period, the study team will conduct surveys and semi-structured
      interviews with study clinicians. The survey results will be used to identify correlates of
      primary care clinician uptake of invitations to commit to avoid ordering low-value services.
      The semi-structured interviews will elicit qualitative data on clinician attitudes towards
      overuse of low-value services, clinicians' responses to the intervention, and facilitators of
      and barriers to avoidance of delivering low-value care.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Composite rates of ordering 3 potentially low-value services in primary care visits by adult patients
time frame: Within 10 months of receiving the intervention
description: Composite rates of ordering lumbar spine imaging tests in visits for low back pain, ordering antibiotics in visits for acute sinusitis, and ordering head imaging tests in visits for headaches.
measure: Composite rates of ordering potential substitute services for 3 potentially low-value services in primary care visits by adult patients
time frame: Within 10 months of receiving the intervention
description: Composite rates of ordering potential substitute services for lumbar spine imaging tests in visits for low back pain, ordering antibiotics in visits for acute sinusitis, and ordering head imaging tests in visits for headaches.
arm group label: Commitment invitation at time 1
arm group type: Experimental
description: Intervention: Behavioral: Commitment Invitation
In the stepped wedge cluster randomized design, the first clinic will remain in the control period (no intervention) for 2 months and then cross over to the intervention period for 6 months.
arm group label: Commitment invitation at time 2
arm group type: Experimental
description: Intervention: Behavioral: Commitment Invitation
In the stepped wedge cluster randomized design, the second clinic will remain in the control period (no intervention) for 3 months and then cross over to the intervention period for 5 months.
arm group label: Commitment invitation at time 3
arm group type: Experimental
description: Intervention: Behavioral: Commitment Invitation
In the stepped wedge cluster randomized design, the third clinic will remain in the control period (no intervention) for 4 months and then cross over to the intervention period for 4 months.
arm group label: Commitment invitation at time 4
arm group type: Experimental
description: Intervention: Behavioral: Commitment Invitation
In the stepped wedge cluster randomized design, the fourth clinic will remain in the control period (no intervention) for 5 months and then cross over to the intervention period for 3 months.
arm group label: Commitment invitation at time 5
arm group type: Experimental
description: Intervention: Behavioral: Commitment Invitation
In the stepped wedge cluster randomized design, the fifth clinic will remain in the control period (no intervention) for 6 months and then cross over to the intervention period for 2 months.
arm group label: Commitment invitation at time 6
arm group type: Experimental
description: Intervention: Behavioral: Commitment Invitation
In the stepped wedge cluster randomized design, the sixth clinic will remain in the control period (no intervention) for 7 months and then cross over to the intervention period for 1 month.
intervention type: Behavioral
intervention name: Commitment invitation
description: Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.
arm group label: Commitment invitation at time 1
arm group label: Commitment invitation at time 2
arm group label: Commitment invitation at time 3
arm group label: Commitment invitation at time 4
arm group label: Commitment invitation at time 5
arm group label: Commitment invitation at time 6
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey T. Kullgren, MD, MS, MPH
role: Principal Investigator
affiliation: University of Michigan
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Jeffrey T. Kullgren
investigator title: Assistant Professor