<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/NCT02208947</url>
  </required_header>
  <id_info>
    <org_study_id>PRO13120230</org_study_id>
    <nct_id>NCT02208947</nct_id>
  </id_info>
  <brief_title>Consumer Engagement to Increase Advance Care Planning</brief_title>
  <official_title>Consumer Engagement to Increase Advance Care Planning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Donaghue Medical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Robert Wood Johnson Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aims of the project are: 1) to test the effectiveness of consumer-directed&#xD;
      financial incentives paired with provider-directed financial incentives, compared to&#xD;
      provider-directed financial incentives alone, for increasing advance care planning (ACP)&#xD;
      among Medicaid beneficiaries; and 2) to assess perceptions regarding the appropriateness of&#xD;
      consumer-directed financial incentives for ACP among study participants. The investigators&#xD;
      hypothesize that consumer-directed financial incentives will result in a 15-percentage point&#xD;
      absolute increase in the proportion of subjects completing ACP. The investigators do not&#xD;
      advance hypotheses about the qualitative component.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a parallel cluster randomized controlled single-blind trial of consumer-directed&#xD;
      financial incentives paired with provider-directed financial incentives (intervention),&#xD;
      compared to provider-directed financial incentives alone (control) on the completion of ACP&#xD;
      among Partnership HealthPlan of California (PHC) Medi-Cal patients. PHC is a county-organized&#xD;
      health system contracted by the State of California to provide a health care delivery system&#xD;
      for 360,000 Medi-Cal beneficiaries in Northern California. PHC has 400 contracted Primary&#xD;
      Care Provider (PCP) entities, representing over 2000 individual physicians, working in solo&#xD;
      practice, small groups, community health centers, large groups, and integrated health&#xD;
      systems. The rationale for using PHC is their commitment to experimenting with strategies to&#xD;
      improve ACP, including their current quality improvement program incentive payment to PCPs to&#xD;
      discuss and document ACP with patients 65+ and &lt;65 with a serious chronic illness.&#xD;
&#xD;
      The investigators will randomize 40 PCPs to one of two different patient education packets&#xD;
      for their patients. Each PCP is eligible for financial incentives for documenting ACP (usual&#xD;
      care), regardless of the randomization group.&#xD;
&#xD;
      Each PCP will be responsible for identifying and enrolling 10 eligible subjects during&#xD;
      routine clinic visits, for a target enrollment of 400 patient subjects.&#xD;
&#xD;
      The investigators will stratify randomization based on salience of the financial incentive&#xD;
      (e.g., accrues directly to non-salaried provider, such as in a private practice, or accrues&#xD;
      to the organization of a salaried provider, such as in a Federally Qualified Health Center or&#xD;
      multispecialty group).&#xD;
&#xD;
      All enrolled patients will receive access to the patient education tool, Prepare for Your&#xD;
      Care (www.prepareforyourcare.org), developed by Dr. Sudore for low-literacy Medi-Cal&#xD;
      populations, in their education packets. The intervention group patients will additionally be&#xD;
      offered a consumer (patient) financial incentive. the primary outcome of the study is having&#xD;
      a conversation with the PCP about ACP. Secondary outcomes include: 1) website use metrics and&#xD;
      2) attitudes about providing financial incentives for ACP (among a purposively sampled subset&#xD;
      of participants).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    failure to accure&#xD;
  </why_stopped>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Advance care planning conversation with provider</measure>
    <time_frame>2 months (+/- 1 month)</time_frame>
    <description>The primary outcome is the patient discussing their ACP with their provider within 2 months of having received the study advance care planning information packet, measured by the provider submitting an attestation form to Partnership HealthPlan of California to receive their ACP quality incentive payment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of the PREPARE website</measure>
    <time_frame>2 months (+/- 1 month)</time_frame>
    <description>The process measure is developing a plan using the PREPARE website, measured by tracking website user metrics and receipt of the subject's &quot;action plan and summary&quot; by e-mail.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Advance Care Planning</condition>
  <arm_group>
    <arm_group_label>PREPARE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Partnership HealthPlan of California (PHC) pays primary care physicians (PCPs) to discuss and document ACP with Medi-Cal beneficiaries aged 65 and older and those younger than 65 with a life-limiting illness (usual care). The control condition, or &quot;enhanced usual care,&quot; adds a packet of educational information about ACP and access to the PREPARE website and verbal encouragement by their PCP delivered during a routine clinic visit to usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PREPARE + consumer financial incentive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental condition adds a consumer-directed financial incentive to enhanced usual care (provider-directed financial incentive and educational packet with information about the PREPARE website). Specifically, subjects will receive an immediate financial reward upon completing self-directed ACP (e.g., PREPARE steps 1-4) and a small probability of a large reward for discussing the plans with their physician (e.g., PREPARE step 5, documented by the PHC ACP attestation form).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Consumer financial incentive</intervention_name>
    <description>Immediate financial reward upon completing self-directed ACP (e.g., completing the web-based educational modules on PREPARE steps 1-4) and a small probability of a large reward for discussing the plans with their physician (e.g., PREPARE step 5, documented by the PHC ACP attestation form).</description>
    <arm_group_label>PREPARE + consumer financial incentive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PREPARE</intervention_name>
    <description>PREPARE for your care is 5-step on-line ACP process developed specifically for low-literacy Medi-Cal populations. PREPARE can be navigated as interactive, self-directed modules or &quot;played&quot; like a movie, at a time or a place of the subject's own choosing (e.g., home, work, public library).</description>
    <arm_group_label>PREPARE</arm_group_label>
    <arm_group_label>PREPARE + consumer financial incentive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PCP Subject Inclusion Criteria:&#xD;
&#xD;
          -  Partnership HealthPlan of California Medicaid and/or Medicare provider&#xD;
&#xD;
        PCP Subject Exclusion Criteria:&#xD;
&#xD;
          -  Prohibition by clinic director&#xD;
&#xD;
        Patient Subject Inclusion Criteria:&#xD;
&#xD;
          -  Partnership HealthPlan of California Medicaid and/or Medicare enrollee;&#xD;
&#xD;
          -  Age 65+ or &lt; 65 with a life-limiting illness (including advanced cardiac disease&#xD;
             [end-stage congestive heart failure, severe coronary artery disease, cardiomyopathy&#xD;
             (LVEF &lt;25%)], advanced chronic obstructive pulmonary disease, amputation due to&#xD;
             vascular disease, cancer [metastatic/recurrent], dementia, diabetes mellitus with&#xD;
             creatinine clearance under 50, or an amputation, end stage renal disease, generalized&#xD;
             debility and decreased functioning, long term resident of skilled nursing facility,&#xD;
             stroke [w/at least 50% decreased function]);&#xD;
&#xD;
          -  Internet access (computer, tablet, phone)&#xD;
&#xD;
        Patient Subject Exclusion Criteria:&#xD;
&#xD;
          -  Completion of a Partnership HelathPlan of California advance care planning attestation&#xD;
             form within the last 12 months;&#xD;
&#xD;
          -  Inability to read English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amber E Barnato, MD MPH MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Partnership HealthPlan-contracting provider groups in Northern California</name>
      <address>
        <city>Fairfield</city>
        <state>California</state>
        <zip>94534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>June 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>June 13, 2017</last_update_submitted>
  <last_update_submitted_qc>June 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Amber Barnato, MD, MPH, MS</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>advance care planning</keyword>
  <keyword>decision making</keyword>
  <keyword>patient engagement</keyword>
  <keyword>patient education</keyword>
  <keyword>financial incentives</keyword>
  <keyword>behavioral economics</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/NCT02208947
org study id: PRO13120230
nct id: NCT02208947
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The specific aims of the project are: 1) to test the effectiveness of consumer-directed
      financial incentives paired with provider-directed financial incentives, compared to
      provider-directed financial incentives alone, for increasing advance care planning (ACP)
      among Medicaid beneficiaries; and 2) to assess perceptions regarding the appropriateness of
      consumer-directed financial incentives for ACP among study participants. The investigators
      hypothesize that consumer-directed financial incentives will result in a 15-percentage point
      absolute increase in the proportion of subjects completing ACP. The investigators do not
      advance hypotheses about the qualitative component.
This is a parallel cluster randomized controlled single-blind trial of consumer-directed
      financial incentives paired with provider-directed financial incentives (intervention),
      compared to provider-directed financial incentives alone (control) on the completion of ACP
      among Partnership HealthPlan of California (PHC) Medi-Cal patients. PHC is a county-organized
      health system contracted by the State of California to provide a health care delivery system
      for 360,000 Medi-Cal beneficiaries in Northern California. PHC has 400 contracted Primary
      Care Provider (PCP) entities, representing over 2000 individual physicians, working in solo
      practice, small groups, community health centers, large groups, and integrated health
      systems. The rationale for using PHC is their commitment to experimenting with strategies to
      improve ACP, including their current quality improvement program incentive payment to PCPs to
      discuss and document ACP with patients 65+ and <65 with a serious chronic illness.

      The investigators will randomize 40 PCPs to one of two different patient education packets
      for their patients. Each PCP is eligible for financial incentives for documenting ACP (usual
      care), regardless of the randomization group.

      Each PCP will be responsible for identifying and enrolling 10 eligible subjects during
      routine clinic visits, for a target enrollment of 400 patient subjects.

      The investigators will stratify randomization based on salience of the financial incentive
      (e.g., accrues directly to non-salaried provider, such as in a private practice, or accrues
      to the organization of a salaried provider, such as in a Federally Qualified Health Center or
      multispecialty group).

      All enrolled patients will receive access to the patient education tool, Prepare for Your
      Care (www.prepareforyourcare.org), developed by Dr. Sudore for low-literacy Medi-Cal
      populations, in their education packets. The intervention group patients will additionally be
      offered a consumer (patient) financial incentive. the primary outcome of the study is having
      a conversation with the PCP about ACP. Secondary outcomes include: 1) website use metrics and
      2) attitudes about providing financial incentives for ACP (among a purposively sampled subset
      of participants).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Advance care planning conversation with provider
time frame: 2 months (+/- 1 month)
description: The primary outcome is the patient discussing their ACP with their provider within 2 months of having received the study advance care planning information packet, measured by the provider submitting an attestation form to Partnership HealthPlan of California to receive their ACP quality incentive payment.
measure: Use of the PREPARE website
time frame: 2 months (+/- 1 month)
description: The process measure is developing a plan using the PREPARE website, measured by tracking website user metrics and receipt of the subject's "action plan and summary" by e-mail.
arm group label: PREPARE
arm group type: Active Comparator
description: Partnership HealthPlan of California (PHC) pays primary care physicians (PCPs) to discuss and document ACP with Medi-Cal beneficiaries aged 65 and older and those younger than 65 with a life-limiting illness (usual care). The control condition, or "enhanced usual care," adds a packet of educational information about ACP and access to the PREPARE website and verbal encouragement by their PCP delivered during a routine clinic visit to usual care.
arm group label: PREPARE + consumer financial incentive
arm group type: Experimental
description: The experimental condition adds a consumer-directed financial incentive to enhanced usual care (provider-directed financial incentive and educational packet with information about the PREPARE website). Specifically, subjects will receive an immediate financial reward upon completing self-directed ACP (e.g., PREPARE steps 1-4) and a small probability of a large reward for discussing the plans with their physician (e.g., PREPARE step 5, documented by the PHC ACP attestation form).
intervention type: Behavioral
intervention name: Consumer financial incentive
description: Immediate financial reward upon completing self-directed ACP (e.g., completing the web-based educational modules on PREPARE steps 1-4) and a small probability of a large reward for discussing the plans with their physician (e.g., PREPARE step 5, documented by the PHC ACP attestation form).
arm group label: PREPARE + consumer financial incentive
intervention type: Behavioral
intervention name: PREPARE
description: PREPARE for your care is 5-step on-line ACP process developed specifically for low-literacy Medi-Cal populations. PREPARE can be navigated as interactive, self-directed modules or "played" like a movie, at a time or a place of the subject's own choosing (e.g., home, work, public library).
arm group label: PREPARE
arm group label: PREPARE + consumer financial incentive
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amber E Barnato, MD MPH MS
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Amber Barnato, MD, MPH, MS
investigator title: Associate Professor