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Improving Healthcare Systems for Access to Care by Underserved Patients (PCORI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02235597
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : November 29, 2017
Patient-Centered Outcomes Research Institute
Arizona State University
Parkview Health
Information provided by (Responsible Party):
Huanmei Wu, Indiana University

Tracking Information
First Submitted Date September 3, 2014
First Posted Date September 10, 2014
Last Update Posted Date November 29, 2017
Study Start Date January 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2014)
patients will have improved access to providers [ Time Frame: 2 years ]
Patients in participating clinics will report improved access to providers for acute and regularly occurring appointments
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02235597 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: September 8, 2014)
Access [ Time Frame: 3 yrs ]
Many patients share the concern "Will I be able to get the care I need if I become ill?" Because our team is a collaborative of patients and stakeholders in Indiana, we anticipate the proposed project will have an immediate impact on access. Expected patient outcomes are increased satisfaction, access, and engagement due to streamlined enrollment and appointment scheduling. Systems will be able to efficiently enroll patients in healthcare plans, and prevent emergency room visits and avoid long waits at clinics
Descriptive Information
Brief Title Improving Healthcare Systems for Access to Care by Underserved Patients
Official Title Improving Healthcare Systems for Access to Care by Underserved Patients
Brief Summary 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).
Detailed Description 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).
Study Type Observational [Patient Registry]
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community Clinic patient Population
Condition Health Services Accessibility
Intervention Not Provided
Study Groups/Cohorts Patients and Staff of Community Clinics
Patients and Staff of Community Clinics who shared strategies and solutions to overcome barriers to accessing health care
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 27, 2017)
Original Estimated Enrollment
 (submitted: September 8, 2014)
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patient at an approved site Community health clinic and over 18 yrs of age.

Exclusion Criteria:

  • do not receive care at an approved site Community health clinic and/or under 18 yrs of age.
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02235597
Other Study ID Numbers PCORI-WU-4198014
Improving Healthcare Systems ( Other Grant/Funding Number: IH -12-11-5488 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Huanmei Wu, Indiana University
Study Sponsor Indiana University
  • Patient-Centered Outcomes Research Institute
  • Arizona State University
  • Parkview Health
Principal Investigator: Huanmei Wu, PhD Indiana University
PRS Account Indiana University
Verification Date November 2017