- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02235597
Improving Healthcare Systems for Access to Care by Underserved Patients (PCORI)
November 27, 2017 updated by: Huanmei Wu, Indiana University
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).
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
92
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Cayuga, Indiana, United States, 47928
- Valley Professionals Community Health Center
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Delphi, Indiana, United States, 46923
- North Central Nursing Clinics
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Indianapolis, Indiana, United States, 46222
- Shalom Health Center
-
Indianapolis, Indiana, United States, 46224
- HealthNet Health Center
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Lafayette, Indiana, United States, 47904
- Riggs Community Health Center
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Muncie, Indiana, United States, 47302
- Open Door Community Health Clinic
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Portage, Indiana, United States, 46368
- North Shore Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community Clinic patient Population
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients and Staff of Community Clinics
Patients and Staff of Community Clinics who shared strategies and solutions to overcome barriers to accessing health care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Huanmei Wu, PhD, Indiana University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
September 3, 2014
First Submitted That Met QC Criteria
September 8, 2014
First Posted (Estimate)
September 10, 2014
Study Record Updates
Last Update Posted (Actual)
November 29, 2017
Last Update Submitted That Met QC Criteria
November 27, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PCORI-WU-4198014
- Improving Healthcare Systems (Other Grant/Funding Number: IH -12-11-5488)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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