<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/NCT03760107</url>
  </required_header>
  <id_info>
    <org_study_id>quitplan2018</org_study_id>
    <nct_id>NCT03760107</nct_id>
  </id_info>
  <brief_title>Factorial Design to Assess Quit-line Connections</brief_title>
  <official_title>Financial Incentives and Proactive Calling for Reducing Barriers to Tobacco Treatment Among Socioeconomically Disadvantaged Populations: A Factorial Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minnesota Department of Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minnesota Department of Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Improved strategies and scalable interventions to engage low-socioeconomic status (SES)&#xD;
      smokers in tobacco treatment are needed. The investigators tested an intervention designed to&#xD;
      connect low-SES smokers to treatment services, implemented through Minnesota's National&#xD;
      Breast and Cervical Cancer Early Detection Program (Sage) in 2017. Participants were female&#xD;
      smokers from Sage (N=3,365). Using a factorial design, participants were randomized to six&#xD;
      intervention groups consisting of a proactive call (no call vs call) and/or a financial&#xD;
      incentive offered for being connected to treatment services (three levels of incentives). All&#xD;
      individuals received direct mail and could opt for cessation support through Minnesota's&#xD;
      population-based cessation services. The primary outcome was confirmed connection via phone&#xD;
      to the free quit-line.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals were randomized to one of six conditions. The design was a two-factor,&#xD;
      three-by-two factorial design: three levels of financial incentives, and two levels of&#xD;
      proactive calls (yes, no). All groups received direct mail and free tobacco treatment&#xD;
      services.&#xD;
&#xD;
      The intervention was implemented from June 2017 to October 2017. National Breast and Cervical&#xD;
      Cancer Early Detection Programs serve uninsured women with household incomes at or below 250%&#xD;
      of the U.S. federal poverty level; subsequently, the sample was strictly female, and the&#xD;
      investigators included individuals for whom self-reported smoking status was available (from&#xD;
      2014 to 2017). Smoking status was determined using Sage data, which come from clinics and&#xD;
      Sage's call center. Using a uniform measure (&quot;Does the participant currently smoke&#xD;
      cigarettes?&quot;), smoking status was based on cigarette use at the time of contact with the Sage&#xD;
      program (i.e., clinic visit or contact with the call center). Data on smoking intensity were&#xD;
      not available. There were 3,723 smokers who met selection criteria.&#xD;
&#xD;
      All participants received two rounds of direct mail. Mailers consisted of a folded card,&#xD;
      which contained messages and graphics rooted in a loss-frame approach. Following previous&#xD;
      research, the loss-frame approach was designed to indicate that certain behaviors lead to&#xD;
      unhealthy outcomes, and the investigators paired the message with a clear articulation of&#xD;
      behavioral steps.&#xD;
&#xD;
      Sage has a call center staffed by patient navigators. When participants called Sage's number,&#xD;
      patient navigators followed a script, recorded callers' promotion code, determined callers'&#xD;
      desire to participate, and made connections to the quit-line for willing participants. After&#xD;
      two rounds of direct mail, patient navigators placed proactive outreach calls to eligible&#xD;
      participants. Phone numbers were retrieved from the Sage database. Using a script, navigators&#xD;
      reminded participants of the direct mail piece and the program offer. Each participant&#xD;
      received one proactive call. One call attempt was made; navigators left a voicemail for&#xD;
      participants who were unavailable. Proactive calling lasted three months.&#xD;
&#xD;
      Both the mailer and navigators referred participants to Minnesota's free population-based&#xD;
      cessation services. The quit-line is funded and administered by an independent nonprofit&#xD;
      organization. Participants can enroll in services either by phone or online. Tobacco users&#xD;
      can choose telephone counseling or one or more individual services.&#xD;
&#xD;
      Our primary outcome was phone-only treatment connection, which was defined as a confirmed&#xD;
      connection between participants and quit-line staff via three-way calls conducted by patient&#xD;
      navigators. For willing participants, patient navigators called quit-line staff and confirmed&#xD;
      that a patient would be connected via a three-way call. Navigators remained on the line until&#xD;
      communication between participants and quit-line staff was established. Once connected,&#xD;
      trained operators from the quit-line were responsible for administering cessation-related&#xD;
      services.&#xD;
&#xD;
      A secondary measure captured connections to online services. This measure combined both phone&#xD;
      and web connections. The web connection assessed whether participants entered their&#xD;
      individual promotion codes (provided via direct mail) on a unique online landing page. Once&#xD;
      participants entered their individual codes, they were directly connected to the cessation&#xD;
      webpage where they entered their personal information and chose tailored treatment services.&#xD;
      Direct transfers to the online services counted as a connection; each code was counted only&#xD;
      once. The investigators used the confirmed phone connection as our primary outcome as it was&#xD;
      a more conservative measure of connection to tobacco treatment services. The investigators&#xD;
      used the measure that combined phone and web connections in secondary analyses.&#xD;
&#xD;
      Intervention components. The investigators used dummy variables to assess levels of financial&#xD;
      incentives (for all three measures: 1=yes, 0=no). The proactive calling measure was assessed&#xD;
      using a dichotomous measure (1=proactive calling, 0=no proactive calling). The investigators&#xD;
      assessed the components' combined effect by generating interaction terms.&#xD;
&#xD;
      Covariates. The investigators examined whether randomized groups differed according to age&#xD;
      (continuous measure ranging from 20 to 88), race/ethnicity (five dichotomous measures: white,&#xD;
      African American, Hispanic, American Indian, and other races/ethnicities), whether&#xD;
      participants spoke Spanish or not (1=yes, 0=no), whether respondents lived with a fellow&#xD;
      smoker (1=yes, 0=no), time since last contact with Sage (four dichotomous variables: 2014,&#xD;
      2015, 2016, or 2017), and urban residence (1=metro region, 0=other).&#xD;
&#xD;
      Using a per-protocol approach, the investigators eliminated all individuals with bad&#xD;
      addresses. Descriptive statistics were used to compare connection rates and demographics&#xD;
      across intervention arms. The investigators ran a logistic regression model that included&#xD;
      dichotomous measures for all six possible treatment conditions in order to run&#xD;
      post-estimation pairwise comparisons.&#xD;
&#xD;
      Logistic regression is the optimal method for examining unbalanced factorial designs with a&#xD;
      binary outcome. The investigators ran four logistic regression models for the primary&#xD;
      analysis. The investigators examined: (1) the association between incentive levels and&#xD;
      phone-only quit-line connections, (2) the association between proactive calling and&#xD;
      phone-only quit-line connections, (3) the direct effects of financial incentives and&#xD;
      proactive calling, and the interaction between incentive levels and proactive calling, and&#xD;
      (4) the effect of intervention components adjusted for covariates. For the logistic&#xD;
      regression models, the main effects for the incentive and proactive call are interpreted as&#xD;
      the effect when all other variables equal zero, and the interaction coefficients are&#xD;
      interpreted as the test for whether the relationship between proactive calling and&#xD;
      connections to the quit-line depended on receiving an incentive. For the secondary analyses,&#xD;
      the investigators report in the text any differences between the phone-only measure and the&#xD;
      combined measure that combined telephone and web connections.&#xD;
&#xD;
      For cost-effectiveness analysis, the investigators assessed the average cost-effectiveness&#xD;
      ratio, which is the increase in costs by each intervention group compared with the no&#xD;
      incentive, no call group, divided by the increase in connections within each intervention&#xD;
      group compared with the no incentive, no call group. The investigators also examined the&#xD;
      incremental cost-effectiveness ratios, which is the change in cost compared to an adjacent&#xD;
      condition divided by the change in connections compared to the adjacent condition. The&#xD;
      investigators included costs associated with printing, postage, incentives, labor, and the&#xD;
      creation and maintenance of the landing page. Costs were in 2017 US dollars and based on&#xD;
      receipts and labor hours; hourly rates were based on national averages for respective&#xD;
      positions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phone-only treatment connection</measure>
    <time_frame>3 months</time_frame>
    <description>Our primary outcome was phone-only treatment connection, which was defined as a confirmed connection between participants and quit-line staff via three-way calls conducted by patient navigators (1=yes, 0=no).</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">3723</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Incentive Level High, Call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Incentive Level High, No Call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Incentive Level Medium, Call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Incentive Level Medium, No Call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No Incentive, Call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No Incentive, No Call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Connect Smokers to Treatment 1</intervention_name>
    <description>Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.</description>
    <arm_group_label>Incentive Level High, Call</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Connect Smokers to Treatment 2</intervention_name>
    <description>Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.</description>
    <arm_group_label>Incentive Level High, No Call</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Connect Smokers to Treatment 3</intervention_name>
    <description>Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.</description>
    <arm_group_label>Incentive Level Medium, Call</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Connect Smokers to Treatment 4</intervention_name>
    <description>Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.</description>
    <arm_group_label>Incentive Level Medium, No Call</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Connect Smokers to Treatment 5</intervention_name>
    <description>Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.</description>
    <arm_group_label>No Incentive, Call</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Connect Smokers to Treatment 6</intervention_name>
    <description>Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.</description>
    <arm_group_label>No Incentive, No Call</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Uninsured women&#xD;
&#xD;
          -  Household incomes at or below 250% of the U.S. federal poverty levels&#xD;
&#xD;
          -  Individuals who reported smoking (from 2014 to 2017)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  Not a National Breast and Cervical Cancer Early Detection Program patient&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Minnesota Department of Health</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55164</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minnesota Department of Health</investigator_affiliation>
    <investigator_full_name>Michael Parks</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <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/NCT03760107
org study id: quitplan2018
nct id: NCT03760107
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Improved strategies and scalable interventions to engage low-socioeconomic status (SES)
      smokers in tobacco treatment are needed. The investigators tested an intervention designed to
      connect low-SES smokers to treatment services, implemented through Minnesota's National
      Breast and Cervical Cancer Early Detection Program (Sage) in 2017. Participants were female
      smokers from Sage (N=3,365). Using a factorial design, participants were randomized to six
      intervention groups consisting of a proactive call (no call vs call) and/or a financial
      incentive offered for being connected to treatment services (three levels of incentives). All
      individuals received direct mail and could opt for cessation support through Minnesota's
      population-based cessation services. The primary outcome was confirmed connection via phone
      to the free quit-line.
Individuals were randomized to one of six conditions. The design was a two-factor,
      three-by-two factorial design: three levels of financial incentives, and two levels of
      proactive calls (yes, no). All groups received direct mail and free tobacco treatment
      services.

      The intervention was implemented from June 2017 to October 2017. National Breast and Cervical
      Cancer Early Detection Programs serve uninsured women with household incomes at or below 250%
      of the U.S. federal poverty level; subsequently, the sample was strictly female, and the
      investigators included individuals for whom self-reported smoking status was available (from
      2014 to 2017). Smoking status was determined using Sage data, which come from clinics and
      Sage's call center. Using a uniform measure ("Does the participant currently smoke
      cigarettes?"), smoking status was based on cigarette use at the time of contact with the Sage
      program (i.e., clinic visit or contact with the call center). Data on smoking intensity were
      not available. There were 3,723 smokers who met selection criteria.

      All participants received two rounds of direct mail. Mailers consisted of a folded card,
      which contained messages and graphics rooted in a loss-frame approach. Following previous
      research, the loss-frame approach was designed to indicate that certain behaviors lead to
      unhealthy outcomes, and the investigators paired the message with a clear articulation of
      behavioral steps.

      Sage has a call center staffed by patient navigators. When participants called Sage's number,
      patient navigators followed a script, recorded callers' promotion code, determined callers'
      desire to participate, and made connections to the quit-line for willing participants. After
      two rounds of direct mail, patient navigators placed proactive outreach calls to eligible
      participants. Phone numbers were retrieved from the Sage database. Using a script, navigators
      reminded participants of the direct mail piece and the program offer. Each participant
      received one proactive call. One call attempt was made; navigators left a voicemail for
      participants who were unavailable. Proactive calling lasted three months.

      Both the mailer and navigators referred participants to Minnesota's free population-based
      cessation services. The quit-line is funded and administered by an independent nonprofit
      organization. Participants can enroll in services either by phone or online. Tobacco users
      can choose telephone counseling or one or more individual services.

      Our primary outcome was phone-only treatment connection, which was defined as a confirmed
      connection between participants and quit-line staff via three-way calls conducted by patient
      navigators. For willing participants, patient navigators called quit-line staff and confirmed
      that a patient would be connected via a three-way call. Navigators remained on the line until
      communication between participants and quit-line staff was established. Once connected,
      trained operators from the quit-line were responsible for administering cessation-related
      services.

      A secondary measure captured connections to online services. This measure combined both phone
      and web connections. The web connection assessed whether participants entered their
      individual promotion codes (provided via direct mail) on a unique online landing page. Once
      participants entered their individual codes, they were directly connected to the cessation
      webpage where they entered their personal information and chose tailored treatment services.
      Direct transfers to the online services counted as a connection; each code was counted only
      once. The investigators used the confirmed phone connection as our primary outcome as it was
      a more conservative measure of connection to tobacco treatment services. The investigators
      used the measure that combined phone and web connections in secondary analyses.

      Intervention components. The investigators used dummy variables to assess levels of financial
      incentives (for all three measures: 1=yes, 0=no). The proactive calling measure was assessed
      using a dichotomous measure (1=proactive calling, 0=no proactive calling). The investigators
      assessed the components' combined effect by generating interaction terms.

      Covariates. The investigators examined whether randomized groups differed according to age
      (continuous measure ranging from 20 to 88), race/ethnicity (five dichotomous measures: white,
      African American, Hispanic, American Indian, and other races/ethnicities), whether
      participants spoke Spanish or not (1=yes, 0=no), whether respondents lived with a fellow
      smoker (1=yes, 0=no), time since last contact with Sage (four dichotomous variables: 2014,
      2015, 2016, or 2017), and urban residence (1=metro region, 0=other).

      Using a per-protocol approach, the investigators eliminated all individuals with bad
      addresses. Descriptive statistics were used to compare connection rates and demographics
      across intervention arms. The investigators ran a logistic regression model that included
      dichotomous measures for all six possible treatment conditions in order to run
      post-estimation pairwise comparisons.

      Logistic regression is the optimal method for examining unbalanced factorial designs with a
      binary outcome. The investigators ran four logistic regression models for the primary
      analysis. The investigators examined: (1) the association between incentive levels and
      phone-only quit-line connections, (2) the association between proactive calling and
      phone-only quit-line connections, (3) the direct effects of financial incentives and
      proactive calling, and the interaction between incentive levels and proactive calling, and
      (4) the effect of intervention components adjusted for covariates. For the logistic
      regression models, the main effects for the incentive and proactive call are interpreted as
      the effect when all other variables equal zero, and the interaction coefficients are
      interpreted as the test for whether the relationship between proactive calling and
      connections to the quit-line depended on receiving an incentive. For the secondary analyses,
      the investigators report in the text any differences between the phone-only measure and the
      combined measure that combined telephone and web connections.

      For cost-effectiveness analysis, the investigators assessed the average cost-effectiveness
      ratio, which is the increase in costs by each intervention group compared with the no
      incentive, no call group, divided by the increase in connections within each intervention
      group compared with the no incentive, no call group. The investigators also examined the
      incremental cost-effectiveness ratios, which is the change in cost compared to an adjacent
      condition divided by the change in connections compared to the adjacent condition. The
      investigators included costs associated with printing, postage, incentives, labor, and the
      creation and maintenance of the landing page. Costs were in 2017 US dollars and based on
      receipts and labor hours; hourly rates were based on national averages for respective
      positions.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Phone-only treatment connection
time frame: 3 months
description: Our primary outcome was phone-only treatment connection, which was defined as a confirmed connection between participants and quit-line staff via three-way calls conducted by patient navigators (1=yes, 0=no).
arm group label: Incentive Level High, Call
arm group type: Experimental
arm group label: Incentive Level High, No Call
arm group type: Experimental
arm group label: Incentive Level Medium, Call
arm group type: Experimental
arm group label: Incentive Level Medium, No Call
arm group type: Experimental
arm group label: No Incentive, Call
arm group type: Experimental
arm group label: No Incentive, No Call
arm group type: Experimental
intervention type: Behavioral
intervention name: Connect Smokers to Treatment 1
description: Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
arm group label: Incentive Level High, Call
intervention type: Behavioral
intervention name: Connect Smokers to Treatment 2
description: Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
arm group label: Incentive Level High, No Call
intervention type: Behavioral
intervention name: Connect Smokers to Treatment 3
description: Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
arm group label: Incentive Level Medium, Call
intervention type: Behavioral
intervention name: Connect Smokers to Treatment 4
description: Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
arm group label: Incentive Level Medium, No Call
intervention type: Behavioral
intervention name: Connect Smokers to Treatment 5
description: Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
arm group label: No Incentive, Call
intervention type: Behavioral
intervention name: Connect Smokers to Treatment 6
description: Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
arm group label: No Incentive, No Call
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Minnesota Department of Health
investigator full name: Michael Parks
investigator title: Senior Research Scientist
sharing ipd: No