<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/NCT02188667</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201300433</org_study_id>
    <secondary_id>8578749</secondary_id>
    <nct_id>NCT02188667</nct_id>
  </id_info>
  <brief_title>Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care</brief_title>
  <acronym>I-PRO</acronym>
  <official_title>An Integrative and Sustainable Approach to Pain Management in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the impact of clinician education, electronic health&#xD;
      record integrated patient reported outcomes, and electronic health record integrated decision&#xD;
      support on pain-related care quality, outcomes, and service utilization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The initiative has three components to aid clinicians' care of patients with chronic&#xD;
      noncancer pain: (1) education, (2) standardized patient reported outcomes data collection,&#xD;
      and (3) evidence-based brief treatment reminders. Practices will be randomized to either&#xD;
      receive the three novel components (treatment group) or continue with usual care (control&#xD;
      group).&#xD;
&#xD;
      Providers in the treatment group will be asked (a) to complete a series of six online&#xD;
      education modules in pain care, (b) will be given access to new patient reported outcomes&#xD;
      questionnaire data collected from patients within the electronic health record, (c) asked to&#xD;
      review this data and related care recommendations during the patient visit, and (d) asked to&#xD;
      complete baseline and monthly online surveys related to experiences and satisfaction with&#xD;
      providing care to patients with chronic noncancer pain.&#xD;
&#xD;
      Providers in the control group will provide care as usual to patients and will be asked to&#xD;
      complete baseline and monthly online surveys related to experiences and satisfaction with&#xD;
      providing care to patients with chronic noncancer pain.&#xD;
&#xD;
      Primary study outcomes include comparison of treatment and control group provider and patient&#xD;
      satisfaction surveys. Secondary outcome measures include provider referral rates, patient&#xD;
      outcomes, patient treatments recommended/ordered, and patient service utilization/costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Provider Satisfaction Survey</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>This is a 16 item web based questionnaire about general experiences and satisfaction with providing care to patients with chronic noncancer pain. Data will be collected at baseline (June 2014) and monthly thereafter through the end of the study period (July 2014 - September 2015). Provider satisfaction data for both the treatment and control groups will be compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction Survey</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>This is a four to five question phone survey (depending on whether patient is seeing a provider in a treatment or control group) about general and pain-specific satisfaction with visit. Data will be collected after each visit for chronic noncancer pain through the study period (July 2014 - September 2015). Patient satisfaction data for both the treatment and control groups will be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Readmission Rates</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The data will be collected retrospectively for a history of hospital readmission rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lab Orders and Results</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The data will be collected retrospectively for a history of lab orders and results (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data will be</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescribed and Dispensed Medications</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The data will be collected retrospectively for a history of prescribed and dispensed medications (June 2011 - June 2015). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The data will be collected retrospectively for a history of pain intensity (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Costs</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The data will be collected retrospectively for a history of medical costs (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.This will include cost of pain related care for charge amounts and billed amounts for specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Care Utilization</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The data will be collected retrospectively for a history of health care utilization (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. This will include utilization of specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Specialist Referral Rates</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The data will be collected retrospectively for a history of pain specialist referral rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Chronic Noncancer Pain</condition>
  <arm_group>
    <arm_group_label>Providers of Novel Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Providers of Usual Care</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Providers of Novel Care</intervention_name>
    <description>Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.</description>
    <arm_group_label>Providers of Novel Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Providers of Usual Care</intervention_name>
    <description>Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.</description>
    <arm_group_label>Providers of Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Providers at one of six active Community Health and Family Medicine locations in the&#xD;
             University of Florida Health system Gainesville service area (Hampton Oaks, Eastside,&#xD;
             Jonesville, and Haile) between May 1, 2014 and September 1, 2015&#xD;
&#xD;
          -  Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Advanced Registered&#xD;
             Nurse Practitioner (ARNP), Physician Assistant (PA) or other faculty professional&#xD;
             providing primary care services&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Residents or other trainees at one of four active Community Health and Family Medicine&#xD;
             locations in the University of Florida Health system Gainesville service area (Hampton&#xD;
             Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher A Harle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert W Hurley, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicole Marlow, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Family Medicine at Hampton Oaks</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medicine at Haile Plantation</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastside Community Practice</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32641</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medicine at Jonesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32669</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Noncancer Pain</keyword>
  <keyword>Musculoskeletal Pain</keyword>
  <keyword>Neuropathic Pain</keyword>
  <keyword>Headache Pain</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02188667
org study id: IRB201300433
secondary id: 8578749
nct id: NCT02188667
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the impact of clinician education, electronic health
      record integrated patient reported outcomes, and electronic health record integrated decision
      support on pain-related care quality, outcomes, and service utilization.
The initiative has three components to aid clinicians' care of patients with chronic
      noncancer pain: (1) education, (2) standardized patient reported outcomes data collection,
      and (3) evidence-based brief treatment reminders. Practices will be randomized to either
      receive the three novel components (treatment group) or continue with usual care (control
      group).

      Providers in the treatment group will be asked (a) to complete a series of six online
      education modules in pain care, (b) will be given access to new patient reported outcomes
      questionnaire data collected from patients within the electronic health record, (c) asked to
      review this data and related care recommendations during the patient visit, and (d) asked to
      complete baseline and monthly online surveys related to experiences and satisfaction with
      providing care to patients with chronic noncancer pain.

      Providers in the control group will provide care as usual to patients and will be asked to
      complete baseline and monthly online surveys related to experiences and satisfaction with
      providing care to patients with chronic noncancer pain.

      Primary study outcomes include comparison of treatment and control group provider and patient
      satisfaction surveys. Secondary outcome measures include provider referral rates, patient
      outcomes, patient treatments recommended/ordered, and patient service utilization/costs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Provider Satisfaction Survey
time frame: Up to 15 months
description: This is a 16 item web based questionnaire about general experiences and satisfaction with providing care to patients with chronic noncancer pain. Data will be collected at baseline (June 2014) and monthly thereafter through the end of the study period (July 2014 - September 2015). Provider satisfaction data for both the treatment and control groups will be compared.
measure: Patient Satisfaction Survey
time frame: Up to 15 months
description: This is a four to five question phone survey (depending on whether patient is seeing a provider in a treatment or control group) about general and pain-specific satisfaction with visit. Data will be collected after each visit for chronic noncancer pain through the study period (July 2014 - September 2015). Patient satisfaction data for both the treatment and control groups will be compared.
measure: Hospital Readmission Rates
time frame: Up to 5 years
description: The data will be collected retrospectively for a history of hospital readmission rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
measure: Lab Orders and Results
time frame: Up to 5 years
description: The data will be collected retrospectively for a history of lab orders and results (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data will be
measure: Prescribed and Dispensed Medications
time frame: Up to 5 years
description: The data will be collected retrospectively for a history of prescribed and dispensed medications (June 2011 - June 2015). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
measure: Pain Intensity
time frame: Up to 5 years
description: The data will be collected retrospectively for a history of pain intensity (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
measure: Medical Costs
time frame: Up to 5 years
description: The data will be collected retrospectively for a history of medical costs (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.This will include cost of pain related care for charge amounts and billed amounts for specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.
measure: Health Care Utilization
time frame: Up to 5 years
description: The data will be collected retrospectively for a history of health care utilization (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. This will include utilization of specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.
measure: Pain Specialist Referral Rates
time frame: Up to 5 years
description: The data will be collected retrospectively for a history of pain specialist referral rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
arm group label: Providers of Novel Care
arm group type: Active Comparator
description: Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
arm group label: Providers of Usual Care
arm group type: Sham Comparator
description: Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
intervention type: Other
intervention name: Providers of Novel Care
description: Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
arm group label: Providers of Novel Care
intervention type: Other
intervention name: Providers of Usual Care
description: Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
arm group label: Providers of Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher A Harle, PhD
role: Principal Investigator
affiliation: University of Florida
last name: Robert W Hurley, MD, PhD
role: Principal Investigator
affiliation: University of Florida
last name: Nicole Marlow, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided