<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/NCT02235597</url>
  </required_header>
  <id_info>
    <org_study_id>PCORI-WU-4198014</org_study_id>
    <secondary_id>Improving Healthcare Systems</secondary_id>
    <nct_id>NCT02235597</nct_id>
  </id_info>
  <brief_title>Improving Healthcare Systems for Access to Care by Underserved Patients</brief_title>
  <acronym>PCORI</acronym>
  <official_title>Improving Healthcare Systems for Access to Care by Underserved Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Parkview Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators seek to improve health systems so underserved people, patients without&#xD;
      insurance, Medicaid, Medicare, as well as self pay and their caregivers can better access&#xD;
      health care for common problems and acute care needs (same day appointments).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are different types of participants in this study. Measurements will be assessed with a&#xD;
      questionnaire. The first category includes patients, caregivers, clinical and operational&#xD;
      leaders, and researchers who will be invited for the Delphi study to identify potential&#xD;
      barriers to access and strategies to improve access. The second category includes clinic&#xD;
      staff (physicians, nurses, medical assistants, registrars, etc.) and patients who will be&#xD;
      interviewed during their clinic visits to identify key processes and patients' opinion about&#xD;
      barriers to access. The third category includes all enrolled patients to identify the patient&#xD;
      population characteristics. The fourth category includes the patients and providers of CHCs&#xD;
      in the participating clinics who will be surveyed to assess experience with access to care&#xD;
      and satisfaction with the changes in workflow and efficiency.Category 1: Delphi study. The&#xD;
      investigators will invite 50-60 individuals (patients, caregivers, clinical and operational&#xD;
      leaders, and researchers) for a panel size of 40-50. Category 2: Key Informant Interviews&#xD;
      (Patients and clinic staff (physicians, nurses, medical assistants, registrars, etc). The&#xD;
      investigators will interview at least one patient every time we go to the participating&#xD;
      clinics. The investigators plan to visit each of the participating CHCs approximately every&#xD;
      two months. The investigators expect to interview approximately 12 patients at each clinic&#xD;
      each year, for a total of 84 each year at the seven clinics. Thus, the total number of&#xD;
      patients interviewed will be 252 in three years (12 patients / clinic x 7 clinics = 84&#xD;
      patients per year). The interview questions will be related to access barriers and efficiency&#xD;
      of clinic processes. The investigators will receive the consent of the patient before&#xD;
      starting the interview. The investigators will use IRB-approved consent forms for the study.&#xD;
      The investigators will interview ten staff members during each visit to identify the key&#xD;
      processes. The investigators anticipate interviewing approximately 8 providers and staff in&#xD;
      each clinic during our bimonthly visits, as well as 3-4 during our bimonthly phone calls&#xD;
      during the project period. This is expected to total 12 staff (including providers and&#xD;
      managers) every two months at each clinic, or 6 x 12 = 72. This should total 72 x 7 = 504 at&#xD;
      all the clinics each year. Some of these interviews will be quite brief, lasting only a few&#xD;
      minutes, while others may last 45-60 minutes. Category 3: The investigators will collect&#xD;
      de-identified patient data for the patient populations cared for by the participating CHCs,&#xD;
      that will include age, gender, race, marital status, education, language, income, insurance,&#xD;
      distance to healthcare facility, reason of the visit, diagnoses, co-morbidities, number of&#xD;
      regular visits, visit types and durations, provider types, and time between visits. The&#xD;
      investigators will work with IT and/or quality improvement staff at each of the CHCs to&#xD;
      develop standard procedures to retrieve and de identify the data from electronic medical&#xD;
      records and scheduling system. The investigators will analyze the data to determine patient&#xD;
      population characteristics and care needs to inform the simulation models and analysis of&#xD;
      impact of the interventions. In 2011, the total number of patients seen in seven partner&#xD;
      clinic systems were approximately 130,000. However, the partner clinics provide care services&#xD;
      at several sites. The investigators will choose a single site from each CHC system and&#xD;
      analyze the data for the patients who had at least two prior visits to the selected site&#xD;
      within two years prior to baseline. The investigators expect to analyze the visits for 60,000&#xD;
      patients. The data for each clinic will be analyzed separately. Category 4; The investigators&#xD;
      anticipate surveying a sample of patients at each of the clinics to assess familiarity with&#xD;
      how to obtain access to care, knowledge of the intervention and satisfaction with access.&#xD;
      This will be a blinded (deidentified survey) and not linked to any individual data, other&#xD;
      than study site. The investigators anticipate sampling 100 patients at each site, including&#xD;
      approximately 65 patients who participate at each site., per site. In this study, the&#xD;
      investigators will not consider special vulnerable populations (fetuses, neonates, prisoners,&#xD;
      and institutionalized individuals).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>patients will have improved access to providers</measure>
    <time_frame>2 years</time_frame>
    <description>Patients in participating clinics will report improved access to providers for acute and regularly occurring appointments</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Health Services Accessibility</condition>
  <arm_group>
    <arm_group_label>Patients and Staff of Community Clinics</arm_group_label>
    <description>Patients and Staff of Community Clinics who shared strategies and solutions to overcome barriers to accessing health care</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Community Clinic patient Population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient at an approved site Community health clinic and over 18 yrs of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not receive care at an approved site Community health clinic and/or under 18 yrs of&#xD;
             age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huanmei Wu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Valley Professionals Community Health Center</name>
      <address>
        <city>Cayuga</city>
        <state>Indiana</state>
        <zip>47928</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Central Nursing Clinics</name>
      <address>
        <city>Delphi</city>
        <state>Indiana</state>
        <zip>46923</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shalom Health Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthNet Health Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riggs Community Health Center</name>
      <address>
        <city>Lafayette</city>
        <state>Indiana</state>
        <zip>47904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Open Door Community Health Clinic</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Health Center</name>
      <address>
        <city>Portage</city>
        <state>Indiana</state>
        <zip>46368</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Coulter A, Locock L, Ziebland S, Calabrese J. Collecting data on patient experience is not enough: they must be used to improve care. BMJ. 2014 Mar 26;348:g2225. doi: 10.1136/bmj.g2225. No abstract available.</citation>
    <PMID>24671966</PMID>
  </results_reference>
  <results_reference>
    <citation>Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.</citation>
    <PMID>23381514</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>November 27, 2017</last_update_submitted>
  <last_update_submitted_qc>November 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Huanmei Wu</investigator_full_name>
    <investigator_title>Associate Professor BioHealth Informatics</investigator_title>
  </responsible_party>
  <keyword>patient access</keyword>
  <keyword>patient centered care</keyword>
  <keyword>scheduling</keyword>
  <keyword>access barriers</keyword>
  <keyword>improve efficiency</keyword>
  <keyword>decision making tools</keyword>
  <keyword>underserved</keyword>
  <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/NCT02235597
org study id: PCORI-WU-4198014
secondary id: Improving Healthcare Systems
nct id: NCT02235597
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The investigators seek to improve health systems so underserved people, patients without
      insurance, Medicaid, Medicare, as well as self pay and their caregivers can better access
      health care for common problems and acute care needs (same day appointments).
There are different types of participants in this study. Measurements will be assessed with a
      questionnaire. The first category includes patients, caregivers, clinical and operational
      leaders, and researchers who will be invited for the Delphi study to identify potential
      barriers to access and strategies to improve access. The second category includes clinic
      staff (physicians, nurses, medical assistants, registrars, etc.) and patients who will be
      interviewed during their clinic visits to identify key processes and patients' opinion about
      barriers to access. The third category includes all enrolled patients to identify the patient
      population characteristics. The fourth category includes the patients and providers of CHCs
      in the participating clinics who will be surveyed to assess experience with access to care
      and satisfaction with the changes in workflow and efficiency.Category 1: Delphi study. The
      investigators will invite 50-60 individuals (patients, caregivers, clinical and operational
      leaders, and researchers) for a panel size of 40-50. Category 2: Key Informant Interviews
      (Patients and clinic staff (physicians, nurses, medical assistants, registrars, etc). The
      investigators will interview at least one patient every time we go to the participating
      clinics. The investigators plan to visit each of the participating CHCs approximately every
      two months. The investigators expect to interview approximately 12 patients at each clinic
      each year, for a total of 84 each year at the seven clinics. Thus, the total number of
      patients interviewed will be 252 in three years (12 patients / clinic x 7 clinics = 84
      patients per year). The interview questions will be related to access barriers and efficiency
      of clinic processes. The investigators will receive the consent of the patient before
      starting the interview. The investigators will use IRB-approved consent forms for the study.
      The investigators will interview ten staff members during each visit to identify the key
      processes. The investigators anticipate interviewing approximately 8 providers and staff in
      each clinic during our bimonthly visits, as well as 3-4 during our bimonthly phone calls
      during the project period. This is expected to total 12 staff (including providers and
      managers) every two months at each clinic, or 6 x 12 = 72. This should total 72 x 7 = 504 at
      all the clinics each year. Some of these interviews will be quite brief, lasting only a few
      minutes, while others may last 45-60 minutes. Category 3: The investigators will collect
      de-identified patient data for the patient populations cared for by the participating CHCs,
      that will include age, gender, race, marital status, education, language, income, insurance,
      distance to healthcare facility, reason of the visit, diagnoses, co-morbidities, number of
      regular visits, visit types and durations, provider types, and time between visits. The
      investigators will work with IT and/or quality improvement staff at each of the CHCs to
      develop standard procedures to retrieve and de identify the data from electronic medical
      records and scheduling system. The investigators will analyze the data to determine patient
      population characteristics and care needs to inform the simulation models and analysis of
      impact of the interventions. In 2011, the total number of patients seen in seven partner
      clinic systems were approximately 130,000. However, the partner clinics provide care services
      at several sites. The investigators will choose a single site from each CHC system and
      analyze the data for the patients who had at least two prior visits to the selected site
      within two years prior to baseline. The investigators expect to analyze the visits for 60,000
      patients. The data for each clinic will be analyzed separately. Category 4; The investigators
      anticipate surveying a sample of patients at each of the clinics to assess familiarity with
      how to obtain access to care, knowledge of the intervention and satisfaction with access.
      This will be a blinded (deidentified survey) and not linked to any individual data, other
      than study site. The investigators anticipate sampling 100 patients at each site, including
      approximately 65 patients who participate at each site., per site. In this study, the
      investigators will not consider special vulnerable populations (fetuses, neonates, prisoners,
      and institutionalized individuals).
observational model: Ecologic or Community
time perspective: Prospective
measure: patients will have improved access to providers
time frame: 2 years
description: Patients in participating clinics will report improved access to providers for acute and regularly occurring appointments
arm group label: Patients and Staff of Community Clinics
description: Patients and Staff of Community Clinics who shared strategies and solutions to overcome barriers to accessing health care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Huanmei Wu, PhD
role: Principal Investigator
affiliation: Indiana University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Coulter A, Locock L, Ziebland S, Calabrese J. Collecting data on patient experience is not enough: they must be used to improve care. BMJ. 2014 Mar 26;348:g2225. doi: 10.1136/bmj.g2225. No abstract available.
PMID: 24671966
citation: Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.
PMID: 23381514
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Huanmei Wu
investigator title: Associate Professor BioHealth Informatics
sharing ipd: No